SNPMiner Trials by Shray Alag


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Report for Mutation F53L

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 5 clinical trials

Clinical Trials


1 A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects

Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being approved, alternative regimens need to be tested to determine if new drug combinations have increased effectiveness in treating HIV. The purpose of this study is to test the safety, tolerability, and effectiveness of four different regimens in HIV-infected adults who have never taken anti-HIV drugs.

NCT00118898 HIV Infections Drug: Abacavir/Lamivudine Drug: Atazanavir Drug: Efavirenz Drug: Emtricitabine/Tenofovir disoproxil fumarate Drug: Ritonavir Drug: Abacavir/Lamivudine placebo Drug: Emtricitabine/Tenofovir disoproxil fumarate placebo
MeSH: HIV Infections

Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.. Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.. AIDS-defining illnesses were defined per CDC category C definition. --- T69D --- --- L74I --- --- G190C --- --- L24I --- --- F53L ---

Primary Outcomes

Description: Blood samples for determining virologic failure were obtained at visit weeks 16 and 24 , and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks after randomization and before 24 weeks, or >=200 copies/mL at or after 24 weeks. The 5th percentile for time to virologic failure is the time (in weeks) at which 5% of the participants have experienced virologic failure.

Measure: Time From Randomization to Virologic Failure

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables.

Measure: Time From Treatment Dispensation to a Grade 3/4 Safety Event

Time: All follow-up while on initially assigned regimen; the median (25th, 75th percentile) follow-up while on initial regimen was 120 (54, 156) weeks and the range was 0 to 205 weeks.

Description: Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Time From Treatment Dispensation to Treatment Modification

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Secondary Outcomes

Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Time From Treatment Dispensation to Regimen Failure (First Occurrence of Virologic Failure or Treatment Modification)

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Measure: The Number of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL

Time: At Weeks 48 and 96

Measure: Number of Participants With HIV-1 RNA Levels Less Than 200 Copies/mL

Time: At Weeks 48 and 96

Description: Change was calculated as the CD4 count at Week 48 (or at Week 96) minus the baseline CD4 count (mean of pre-entry and entry values).

Measure: Change in CD4 Count (Cells/mm3) From Baseline

Time: At Weeks 48 and 96

Description: Emergence of resistant virus was assessed by genotypic testing performed at Stanford University for all participants who met criteria for virologic failure and retrospectively on baseline samples from these participants. Major mutations were defined by International AIDS Society-United States of America (2008), as well as T69D, L74I, G190C/E/Q/T/V for reverse transcriptase and L24I, F53L, I54V/A/T/S, G73C/S/T/A, N88D for protease.

Measure: Number of Participants With Virologic Failure and Emergence of Major Resistance

Time: Follow-up time was variable,median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: AIDS-defining illnesses were defined per CDC category C definition. HIV-1 related events were defined per CDC category B definition. Events underwent study chair review for classification. See link below for more details. http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm

Measure: Number of Participants Experiencing Certain Targeted Clinical Events, Including Death, AIDS-defining Illness, and HIV-1 Related Events.

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Total Cholesterol Level From Baseline

Time: At Weeks 48 and 96

Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting High-density Lipoprotein (HDL) Cholesterol Level From Baseline

Time: At Weeks 48 and 96

Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Level From Baseline

Time: At Weeks 48 and 96

Description: Only fasting results are included. The protocol did not require that samples be collected fasting.

Measure: Change in Fasting Triglyceride Level From Baseline

Time: At Weeks 48 and 96

Other Outcomes

Description: Participants were to be followed for 96 weeks after the last enrollment. Accrual was expected to take 96 weeks, thus the planned follow-up time was 96 to 192 weeks, dependent on when in the study the participant enrolled. This outcome summarizes that total amount of actual follow-up in weeks from randomization to last contact.

Measure: Amount of Study Follow-up

Time: Follow-up time was variable, median follow-up was 138 weeks

Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.

Measure: Number of Participants With Virologic Failure

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks.

Measure: Cumulative Probability of Not Experiencing Virologic Failure

Time: At week 48 and 96

Description: Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.

Measure: Number of Participants With a Grade 3/4 Safety Event

Time: Over all study follow-up while on initially assigned treatment, median follow-up was 120 weeks

Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Grade 3/4 safety event is defined as a grade 3 or 4 sign, symptom, or laboratory abnormality that is at least one grade higher than at baseline, total bilirubin and creatine kinase (CPK) were excluded. Grading used the Division of AIDS (DAIDS) 2004 Severity of Adverse Events Tables. As-treated analysis censored at 1st modification of initially assigned regimen, participants who never started treatment were excluded.

Measure: Cumulative Probability of Not Experiencing a Grade 3/4 Safety Event

Time: At week 48 and 96

Description: Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Number of Participants With Treatment Modification

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Treatment modification is defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Cumulative Probability of Not Experiencing Treatment Modification

Time: At week 48 and 96

Description: Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Number of Participants With Regimen Failure

Time: Follow-up time was variable, median follow-up was 138 weeks; see 'Amount of study follow-up' outcome for details

Description: Kaplan-Meier estimate of the cumulative survival probability at week 48 and 96. Blood samples for determining virologic failure were obtained at 16 and 24 weeks, and every 12 weeks thereafter. Virologic failure was defined as a confirmed plasma HIV-1 RNA level >= 1000 copies/mL at or after 16 weeks and before 24 weeks or >=200 copies/mL at or after 24 weeks. Treatment modification was defined as the 1st modification of the regimen, including a permanent discontinuation, switch, or substitution.

Measure: Cumulative Probability of Not Experiencing Regimen Failure

Time: At week 48 and 96

2 A Randomized, Open-Label Study Assessing Safety, Tolerability and Efficacy of an Induction-Maintenance Treatment Strategy Including Lopinavir/Ritonavir Plus Tenofovir Disoproxil Fumarate and Emtricitabine Versus Efavirenz Plus Tenofovir Disoproxil Fumarate and Emtricitabine in Antiviral-naïve HIV-1/HCV Co-Infected Subjects

The purpose of this study is to determine whether a simplified lopinavir/ritonavir-based therapy will continue to keep the viral load at very low levels after initial treatment with a combination of Kaletra (lopinavir/ritonavir) plus tenofovir and emtricitabine.

NCT00121017 HIV Infection Hepatitis C Drug: Kaletra (lopinavir/ritonavir) Drug: Sustiva (efavirenz) Drug: Truvada (emtricitabine/tenofovir disoproxil fumarate)
MeSH: Hepatitis C

- The screening HIV-1 genotype resistance report suggests resistance or possible resistance to the study RTI(s) or lopinavir/ritonavir; Evidence of possible resistance to efavirenz; Presence of one of the following mutations: RT L1001, K103N, V106A or M, V108I, Y181C or I, Y188L, G190A or S, P225H, M230L; Evidence of possible resistance to emtricitabine or lamivudine; Presence of one of the following mutations: RTm184V or I; Evidence of possible resistance to tenofovir; Presence of RT K65R or insertion at codon 69, or Presence of 2 or more of the following mutations: RTm41L, D67N, K70R, L210W; any change at T215, K219Q or evidence of possible resistance to lopinavir/ritonavir; Presence of one or more of the following mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, 190M or Presence of 3 or more of the following mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L; any change at I54, A71V or T, G73S. --- K103N --- --- V106A --- --- V108I --- --- Y181C --- --- Y188L --- --- G190A --- --- P225H --- --- M230L --- --- K65R --- --- D67N --- --- K70R --- --- L210W --- --- K219Q --- --- I47V --- --- G48V --- --- I50V --- --- V82A --- --- I84V --- --- L10F --- --- K20M --- --- L24I --- --- V32I --- --- L33F --- --- M36I --- --- M46I --- --- F53L ---

Primary Outcomes

Measure: The proportion of subjects with a plasma HIV-1 RNA level below 50 copies/mL at Week 96.

Secondary Outcomes

Measure: Vital signs

Measure: Physical examinations

Measure: Clinical laboratory tests

3 Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase. A Multicenter Randomised Phase II/III Open Label Study With a Group of 100 Pregnant Women Receiving Lopinavir/Ritonavir and a Group of 50 Receiving Lopinavir/Ritonavir Plus Zidovudine and Lamivudine. ANRS 135 Primeva

In the pre-partum phase the use of antiretroviral therapy for the mother during the last trimester of pregnancy is mandatory. The use of HAART during pregnancy, usually two nucleosides analogues and a protease inhibitor exposes the mother and the child to cumulate toxicities related to both families. The aim of this study is to assess the use of a boosted protease inhibitor without nucleoside analogue during the pre-partum phase for women with no indication of antiretroviral therapy for their own.

NCT00424814 HIV Infections Drug: Kaletra (lopinavir/ritonavir) Drug: Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine)
MeSH: HIV Infections

Inclusion Criteria: Assessed between 20 and 24 months of pregnancy - Pregnancy known before 24 weeks of gestation - Documented HIV-1 infection without indication for ARV therapy - CD4 count above or equal to 350 per mm3 - VL under 30 000 copies per ml - Naïve for PI (except treatment during previous pregnancy) - Informed consent signed Exclusion Criteria: - HIV2 infection or HIV1 group O infection - Any pathology related to pregnancy - Contra-indication to study drugs - Unstable hypertension or diabetes - Known risk of premature delivery - In case of previous treatment with a protease inhibitor : presence of resistance mutations on the HIV-1 protease gene by genotyping analysis (1 mutation among V32I et I47A, I50V V82A/F/S/T, I84V, L90 M or more than 3 mutations among L10 F/I/R/V, K20/M/R, L24I, L33F, M46I/L, F53L, I54M/L/T/V, L63P, A71L/V/T,) Inclusion Criteria: Assessed between 20 and 24 months of pregnancy - Pregnancy known before 24 weeks of gestation - Documented HIV-1 infection without indication for ARV therapy - CD4 count above or equal to 350 per mm3 - VL under 30 000 copies per ml - Naïve for PI (except treatment during previous pregnancy) - Informed consent signed Exclusion Criteria: - HIV2 infection or HIV1 group O infection - Any pathology related to pregnancy - Contra-indication to study drugs - Unstable hypertension or diabetes - Known risk of premature delivery - In case of previous treatment with a protease inhibitor : presence of resistance mutations on the HIV-1 protease gene by genotyping analysis (1 mutation among V32I et I47A, I50V V82A/F/S/T, I84V, L90 M or more than 3 mutations among L10 F/I/R/V, K20/M/R, L24I, L33F, M46I/L, F53L, I54M/L/T/V, L63P, A71L/V/T,) HIV Infections HIV Infections Recent data from the French perinatal cohort and others indicate that HIV-RNA levels at delivery correlate with risk of transmission among women treated with antiretroviral agents. --- V32I --- --- I47A --- --- I50V --- --- V82A --- --- I84V --- --- L24I --- --- L33F --- --- M46I --- --- F53L ---

Inclusion Criteria: Assessed between 20 and 24 months of pregnancy - Pregnancy known before 24 weeks of gestation - Documented HIV-1 infection without indication for ARV therapy - CD4 count above or equal to 350 per mm3 - VL under 30 000 copies per ml - Naïve for PI (except treatment during previous pregnancy) - Informed consent signed Exclusion Criteria: - HIV2 infection or HIV1 group O infection - Any pathology related to pregnancy - Contra-indication to study drugs - Unstable hypertension or diabetes - Known risk of premature delivery - In case of previous treatment with a protease inhibitor : presence of resistance mutations on the HIV-1 protease gene by genotyping analysis (1 mutation among V32I et I47A, I50V V82A/F/S/T, I84V, L90 M or more than 3 mutations among L10 F/I/R/V, K20/M/R, L24I, L33F, M46I/L, F53L, I54M/L/T/V, L63P, A71L/V/T,) Inclusion Criteria: Assessed between 20 and 24 months of pregnancy - Pregnancy known before 24 weeks of gestation - Documented HIV-1 infection without indication for ARV therapy - CD4 count above or equal to 350 per mm3 - VL under 30 000 copies per ml - Naïve for PI (except treatment during previous pregnancy) - Informed consent signed Exclusion Criteria: - HIV2 infection or HIV1 group O infection - Any pathology related to pregnancy - Contra-indication to study drugs - Unstable hypertension or diabetes - Known risk of premature delivery - In case of previous treatment with a protease inhibitor : presence of resistance mutations on the HIV-1 protease gene by genotyping analysis (1 mutation among V32I et I47A, I50V V82A/F/S/T, I84V, L90 M or more than 3 mutations among L10 F/I/R/V, K20/M/R, L24I, L33F, M46I/L, F53L, I54M/L/T/V, L63P, A71L/V/T,) HIV Infections HIV Infections Recent data from the French perinatal cohort and others indicate that HIV-RNA levels at delivery correlate with risk of transmission among women treated with antiretroviral agents. --- V32I --- --- I47A --- --- I50V --- --- V82A --- --- I84V --- --- L24I --- --- L33F --- --- M46I --- --- F53L --- --- I54M --- --- L63P --- --- A71L --- --- V32I --- --- I47A --- --- I50V --- --- V82A --- --- I84V --- --- L24I --- --- L33F --- --- M46I --- --- F53L ---

Primary Outcomes

Measure: Proportion of mother with plasma HIV1 below 200 copies per ml after 8 weeks of treatment

Time: W8

Secondary Outcomes

Measure: Proportion of women maintained with monotherapy until delivery,

Time: delivery

Measure: Proportion of women with a VL below 50 copies per ml at delivery

Time: delivery

Measure: Proportion of women harbouring resistant HIV strains four weeks after delivery

Time: W4 post partum

Measure: Concentrations of studied drug in plasma and in cord-blood

Time: at delivery

Measure: HIV-1 detection and concentrations of studied drug in vaginal secretion before and after treatment

Time: W0, W8 of treatment

Measure: concentrations of studied drugs in the new born gastric fluid, HIV diagnostic in infant (criteria for stopping the trial at second infection)

Time: birth

4 A 24-week, Randomized, Open-label, 2-arm Study to Compare the Safety, Efficacy and Tolerability of Invirase® Tablets With Ritonavir Versus Kaletra® Tablets in HIV 1 Infected Adults on a Kaletra® Based Regimen With 2 Nucleosides/Nucleotides

This study will compare the benefit for patients switching from Kaletra® to Invirase® tablets over remaining on Kaletra® (based on randomization), to elicit the lipid benefits inferred in previous studies

NCT00438152 HIV Infections Drug: Saquinavir (Invirase®) Drug: Lopinavir/ritonavir (Kaletra®)
MeSH: HIV Infections

- Ability and willingness to provide written informed consent and adhere to the study regimen - Females of childbearing potential must have a documented negative serum or urine pregnancy test at screening/baseline and ensure that 2 reliable forms of contraception are being used, including a barrier method, for the duration of the study and for 90 days after the last dose of study medication Exclusion Criteria: - Documented virological failure on a protease inhibitor ARV regimen prior to commencing Kaletra® regimen - Documented protease mutation (one or more from the following list) prior to commencing Kaletra® regimen: - M46I/L/V, I47A/V, G48V/M, I50V, F53L/Y, I54L/M/V/A/T/S, V82A/T/S/F/M/L, I84A/V/C, L90M - Patients with acute hepatitis B or C infection - Females who are pregnant, breast-feeding, or who plan to become pregnant or breast-feed during the study· - Significant renal dysfunction (creatinine clearance [CrCl] <60 mL/min) and/or hepatic impairment (aspartate aminotransferase/alanine aminotransferase [AST/ALT] >3 X ULN and/or documented liver cirrhosis) Note: The site will calculate each patient's CrCl using the Cockcroft-Gault formula [28] as shown below: CrCl = [140 - age (yr)] × weight (kg) × constant 72 × serum creatinine (Cr) (mg/dL) where, constant = 1 for men and 0.85 for women - Any current known clinical or laboratory parameter of ACTG Grade 4 (see Appendix 4). --- M46I --- --- I47A --- --- G48V --- --- I50V --- --- F53L ---

Primary Outcomes

Measure: To evaluate the lipid benefits of Invirase® tablets with ritonavir versus Kaletra® tablets in HIV-1 infected adults on an antiretroviral regimen containing Kaletra® with two nucleosides/nucleotides

Time: 24 weeks

Secondary Outcomes

Measure: To evaluate the efficacy of Invirase® tablets with ritonavir versus Kaletra® tablets in HIV-1 infected adults on an ARV regimen containing Kaletra® with 2 nucleosides/nucleotides.

Time: 4 weeks, 12 weeks and 24 weeks.

Measure: To evaluate additional safety and tolerability of Invirase® tablets with ritonavir versus Kaletra® tablets in HIV-1 infected adults on an antiretroviral regimen containing Kaletra® with 2 nucleosides/nucleotides.

Time: Week 24

5 A Randomized, Open-label Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice Daily + Raltegravir 400 mg Twice Daily in Antiretroviral Naive, HIV-1 Infected Subjects

The purpose of this study is to compare the safety, tolerability, and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibitors to lopinavir/ritonavir tablets when administered in combination with a human immunodeficiency virus type 1 ( HIV-1) integrase inhibitor in antiretroviral naive HIV-1 infected subjects.

NCT00711009 Human Immunodeficiency Virus Infection Drug: lopinavir/ritonavir (LPV/r) Drug: emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) Drug: raltegravir (RAL)
MeSH: Acqu Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Virus Diseases
HPO: Immunodeficiency

Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.. Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey. --- I47V --- --- G48V --- --- I50V --- --- V82A --- --- I84V --- --- L90M --- --- L10F --- --- K20M --- --- L24I --- --- V32I --- --- L33F --- --- M36I --- --- M46I --- --- F53L ---

Primary Outcomes

Description: A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.

Measure: Percentage of Participants Responding (Plasma HIV-1 Ribonucleic Acid [RNA] Levels Less Than 40 Copies/Milliliter [mL]) at Week 48 Based on the Food and Drug Administration (FDA) Time to Loss of Virologic Response (TLOVR) Algorithm

Time: Baseline to Week 48

Description: Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 days after the last dose of study drug. Treatment-emergent, moderate or severe drug-related adverse events that occurred in at least 2% of participants in either treatment arm are presented.

Measure: Percentage of Participants With Moderate or Severe Treatment-emergent, Drug-related Adverse Events

Time: Week 96

Description: Potentially clinically significant laboratory values that occurred in at least 2% of participants in either treatment arm are presented.

Measure: Primary Outcome: Percentage of Participants With Potentially Clinically Significant Laboratory Values

Time: Baseline to Week 96

Secondary Outcomes

Description: A participant was classified as a responder at the first of 2 consecutive visits with plasma HIV-1 RNA levels below 40 copies/mL. The participant continued to be a responder until one of the following: 1) the participant had 2 consecutive values greater than or equal to 40 copies/mL; the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL; the participant discontinued participation in the study or died.

Measure: Percentage of Participants Responding (Plasma HIV-1 RNA Levels Below 40 Copies/Milliliter [mL]) at Each Visit Based on the FDA Time to Loss of Virologic Response (TLOVR) Algorithm

Time: Baseline to Week 96

Measure: Mean Change in CD4+ T-Cell Counts From Baseline to Each Visit

Time: Baseline to Week 96

Description: Time of loss of virologic response was defined as the first of the following: first of 2 consecutive visits with plasma HIV-1 RNA greater than or equal to 40 copies/milliliter (mL), if the participant previously demonstrated 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; Study Day 1, if the subject never achieved 2 consecutive plasma HIV-1 RNA levels below 40 copies/mL; the day of the final measurement, if the final measurement was the first one documenting an increase in plasma HIV-1 RNA level to greater than or equal to 40 copies/mL.

Measure: Time to Loss of Virologic Response - Percentage of Participants Still Categorized as Responders at Day 672

Time: Baseline to Week 96

Description: Resistance to study drugs was defined as described by the International AIDS Society-USA (IAS-USA) Panel. All participants had an HIV-1 drug resistance genotype (lopinavir/ritonavir, tenofovir, or emtricitabine) obtained at the Screening Visit. Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than or equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance to study drug occurred.

Measure: Number of Participants Who Developed Resistance to Each Drug in the Study Regimen, as Defined by the International AIDS Society-USA (IAS-USA) Panel.

Time: Baseline to Week 96

Description: Beginning at Week 8, if participant's plasma HIV-1 RNA was greater than/equal to 40 copies/milliliter (mL) and was below 40 copies/mL at the previous visit, additional procedures were undertaken to determine if resistance occurred. Evidence of lopinavir resistance was more conservatively defined as the presence of 1 or more of these mutations: protease I47V or A, G48V, I50V, V82A or F or T or S, I84V, L90M; or presence of at least 3 or more of these mutations: protease L10F or I or R or V, K20M or R, L24I, V32I, L33F, M36I, M46I or L, F53L, any change to I54, A71V or T, and G73S.

Measure: Number of Participants Who Developed Resistance, Defined Conservatively, to Lopinavir

Time: Baseline to Week 96

Description: The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (for example, visiting with friends or relatives), and other questions that measure quality of life. The physical component summarizes answers to questions about physical status. Possible scores range from 0 to 100. A higher score indicates better health, and increases indicate improvement.

Measure: Change From Baseline on Physical Component Score of the Medical Outcomes Study HIV Health Survey

Time: Baseline to Week 96

Description: The Survey is a brief, comprehensive health status measure used in studies of people with HIV/AIDS. Participants rate their health and mental/emotional condition, how much their health limits physical activities (eating, dressing, bathing, climbing stairs, walking one block, etc.) and social activities (visiting with friends or relatives, etc.), and other questions that measure quality of life. The mental component summarizes answers to questions about emotional and mental wellbeing. Possible scores range from 0 to 100. Higher scores indicates better health, and increases indicate improvement.

Measure: Change From Baseline on Mental Component of Medical Outcomes Study HIV Health Survey

Time: Baseline to Week 96

Description: The Effectiveness Scale of the TSQM evaluates the participant's satisfaction or dissatisfaction (1=extremely dissatisfied to 7=extremely satisfied) with the ability of the medication to prevent or treat the condition, the way the medication relieves symptoms, the amount of time it takes for the medication to start working, and other questions. Scores are converted to a range of 0 to 100. A higher score indicates greater satisfaction.

Measure: Score on Effectiveness Scale of Treatment Satisfaction Questionnaire for Medication (TSQM)

Time: Week 96

Description: The Side Effects scale of the TSQM asks if the participant experiences side effects (yes/no), and if so, how bothersome the side effects are, to what extent they interfere with physical health and ability to function (for example, strength and energy levels), to what extent they interfere with mental function (for example, ability to think clearly, stay awake, etc.), and to what extent the side effects affect the participants overall satisfaction with the medication. Scores are converted to a range of 0 to 100. Higher scores indicate less interference and/or less dissatisfaction.

Measure: Score on Side Effects Scale of Treatment Satisfaction Questionnaire for Medication

Time: Week 96

Description: The Global Satisfaction scale of the TSQM evaluates the participants rating of whether the good things about the medication outweigh the bad things (1=not at all certain to 5=extremely certain) and how satisfied or dissatisfied the participant is with the medication (1=extremely dissatisfied to 7=extremely satisfied). Scores are converted to a range of 0 to 100. Higher scores indicate greater satisfaction.

Measure: Score on Global Satisfaction Scale of Treatment Satisfaction Questionnaire for Medication

Time: Week 96

Measure: Mean Change From Baseline in Hemoglobin (Grams/Liter)

Time: Baseline to Week 96

Description: Hematocrit fraction is the percentage (%) by volume of packed red blood cells (RBCs) in the participant's blood. It was measured using standard clinical laboratory analysis of participants' blood samples.

Measure: Mean Change From Baseline in Hematocrit (Fraction)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Red Blood Cell Count (x 10^12/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Platelet Count (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in White Blood Cell Count (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Neutrophils (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Lymphocytes (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Monocytes (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Eosinophils (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Basophils (x 10^9/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Alanine Aminotransferase (Units/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Aspartate Aminotransferase (Units/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Alkaline Phosphatase (Units/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Creatine Phosphokinase (Units/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Total Bilirubin (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Creatinine (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Blood Urea Nitrogen (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Uric Acid (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Inorganic Phosphate (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Calcium (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Sodium (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Potassium (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Chloride (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Bicarbonate (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Albumin (Grams/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Total Protein (Grams/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Cholesterol (Micromoles/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in High Density Lipoprotein Cholesterol (HDL) (Micromoles/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Low Density Lipoprotein (LDL) (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Low Density Lipoprotein (LDL): High Density Lipoprotein (HDL) Ratio (Ratio)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Triglycerides (Micromoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Calculated Creatinine Clearance (Milliliters/Second)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Fasting Glucose (Millimoles/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Lactate Dehydrogenase (Units/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Lipase (Units/Liter)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Magnesium (Millimoles/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Adiponectin (Micrograms/Milliliter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Interleukin-6 (Nanograms/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Lactate (Millimoles/Liter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-1 (Picograms/Milliliter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Soluble Tumor Necrosis Factor Receptor-2 (Picograms/Milliliter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Leptin (Nanograms/Milliliter)

Time: Baseline to Week 96

Description: Included in measures of metabolic toxicity

Measure: Mean Change From Baseline in Insulin (Picomoles/Liter)

Time: Baseline to Week 96

Description: Urine specific gravity is a laboratory test that measures the concentration of all chemical particles in the urine. The measurement produces a ratio of the urine density to water density.

Measure: Mean Change From Baseline in Urine Specific Gravity

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Urine pH

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Sitting Systolic Blood Pressure (mm Hg)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Sitting Diastolic Blood Pressure (mm Hg)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Sitting Heart Rate (Beats Per Minute)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Weight (kg)

Time: Baseline to Week 96

Measure: Mean Change From Baseline in Temperature (°F)

Time: Baseline to Week 96

Description: Chest circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant's chest circumference was measured at 5 cm above the xiphoid process using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Chest Measurement (cm)

Time: Baseline to Week 96

Description: Waist circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Circumference of participant's waist was measured at the level of the navel using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Waist Measurement (cm)

Time: Baseline to Week 96

Description: Arm circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's arm circumference was measured halfway between the acromial process on the shoulder and the tip of the elbow (olecranon process) using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Mid-Arm Measurement (cm)

Time: Baseline to Week 96

Description: Hip circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Participant was measured at widest width of the hip using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Hips Measurement (cm)

Time: Baseline to Week 96

Description: Mid-thigh circumference is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen. Particpant's thigh circumference was measured halfway between the inguinal crease and the midpoint of the upper border of the patella using non-stretchable measuring tape with half centimeter marks.

Measure: Mean Change From Baseline in Mid-Thigh Measurement (cm)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Fat (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Lean Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Upper Extremity Total Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Fat (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in DEXA Scan of Lower Extremity Lean Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Lower Extremity Total Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Fat (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Lean Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Trunk Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Fat (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Lean Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan is included in the measures of somatic toxicity, which is characterized by loss of fat in the face, arms, and legs, and increase in fat in the base of the back of the neck and in the abdomen.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Total Body Mass (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Content (Grams)

Time: Baseline to Week 96

Description: The dual energy X-ray absorptiometry (DEXA) scan of bone mineral content was used to evaluate potential bone effects of treatment.

Measure: Mean Change From Baseline in Dual Energy X-ray Absorptiometry (DEXA) Scan of Bone Mineral Density (Grams/cm^2)

Time: Baseline to Week 96


HPO Nodes


Immunodeficiency
Genes 257
LETM1 NFKB2 EPG5 BCL10 AK2 MS4A1 RTEL1 IFNGR2 LIG4 NFKB1 AGPAT2 FCGR3A NFKB2 RNF168 TERT ZBTB24 CHD1 ATRX ANTXR2 PKP1 WIPF1 NOP10 GATA2 HYOU1 XRCC4 SDHD NHP2 IRAK4 CORO1A TBX1 RBCK1 MALT1 TNFRSF4 LAT CD247 IL2RG PARN EPG5 BSCL2 PARN AK2 IRF7 ICOS GATA1 TNFSF12 USB1 ACTB SMARCAL1 UNG TYK2 IL21R TTC7A IL2RB STAT1 IKBKG FGFRL1 FOXN1 HIRA CCDC47 CLCA4 ACD TNFRSF13B MYC AICDA IRAK4 CD3G FCN3 CYBA CTBP1 CHD1 LAMTOR2 LIG4 CAVIN1 SIK3 IL7R LCK ICOS NPM1 MYD88 ORAI1 RAG2 CARD11 PTEN IGHM PTPRC LAMTOR2 RAG1 PGM3 ARVCF TNFRSF1B TNFRSF13C IRF8 SEC24C IL2RG COG6 IKBKG CD28 DKC1 POLE CR2 ADA JMJD1C TCF3 AP3D1 MBTPS2 SHANK3 HELLS COMT UFD1 RAG2 TTC37 IFNGR1 BCL11B CD19 CARD9 BLNK PRKDC CR2 BUB1B MEIS2 RAG1 SDHC NSD2 CTPS1 DOCK2 CDCA7 LMNB2 IRF2BP2 CD79B TERC LYST CD19 FOS CD3E TFRC NCF1 NHEJ1 IRF8 CTC1 LYST LRBA DNMT3B CAV1 CRKL STX1A MAGT1 CPLX1 TNFRSF13B MMUT DCLRE1C RMRP GP1BB CTLA4 DCLRE1C SKIV2L LRRC8A CD81 ICOS TGFB1 XIAP XRCC4 IL7R TTC7A SKIV2L TBCE RTEL1 IGLL1 NCF2 IL21 UNC119 SIN3A WHCR TNFRSF13C ISG15 JAK3 CD79A RAG1 USP8 CD19 CR2 STAT1 CD3D CFTR CYBB IL12RB1 WAS AKT1 IL2RA HBB IKBKB ATM STAT1 STK4 PRKCD ACP5 IKBKG SH2D1A MTHFD1 CDC42 ADA2 PGM3 RAG1 XIAP MAPK1 PIK3R1 SLC46A1 CHD7 MS4A1 FOXN1 RREB1 CDH23 KLLN WRAP53 CD40LG SEC23B ZBTB24 PIK3CA BTK FRAS1 TINF2 RAC2 IKZF1 RAB27A DKC1 DCTN4 TINF2 CD81 DKC1 RAG2 PRPS1 NFKB1 IKBKG IL2RG BCR UROS TNFRSF13C POLE SPATA5 TNFSF12 SDHB ADA CUL4B PIK3R1 STIM1 PIK3CD IL12B SP110 NFE2L2 PPARG TBX1 RNF168 AGL RTEL1 RMRP TERT CD40 DNMT3B