SNPMiner Trials by Shray Alag


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Report for Mutation D30N

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There are 6 clinical trials

Clinical Trials


1 A 24 Week Phase IIIb/IV Single Arm Open Label Observational Study to Explore the Efficacy of Protease Inhibitors Given in Combination With Reverse Transcriptase Inhibitors to HIV-1 Infected Subjects With Protease Mutations Selected During Therapy With GW433908 Containing Antiretroviral Therapy

This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.

NCT00242840 Infection, Human Immunodeficiency Virus I HIV Infection Drug: No intervention; Observational study
MeSH: Infection Communicable Diseases HIV Infections Acquired Immunodeficiency Syndrome

Exclusion criteria: - Have 2 or more of the primary resistance mutations D30N, G48V, V82A/F/T/S and L90M. --- D30N ---


2 Prospective Clinical Trial to Assess Safety and Efficacy of DRV/r(TMC 114/r), ETV(TMC 125) and MK-0518 in Addition to OBT in HIV-1 Infected Patients With Limited to No Treatment Options ANRS 139 TRIO

The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.

NCT00460382 HIV Infections Drug: raltegravir potassium Drug: darunavir/ritonavir Drug: etravirine Drug: Optimized background regimen
MeSH: HIV Infections

- Genotypic resistance testing at the screening visit: - Protease inhibitor mutations: over or equal to 3 primary protease inhibitor mutations among: D30N, V32I, L33F, M46I/L, I47A/V, G48V, I50L/V, I54M, L76V, V82A/F/L/T/S, I84V, N88S and L90M (IAS list 2006) but below or equal to 3 mutations among the following: V11I, V32I, L33F, I47V, I50V, I54L/M, G73S, L76V, I84V et L89V (virus sensitivity to darunavir/ritonavir). - Reverse transcriptase mutations: over or equal to 3 NRTI mutations (among IAS list) and below or equal to 3 mutations among: A98G, L100I, K101Q/P/E, K103H/N/S/T, V106A/M, V108I, E138G/K/Q, V179D/E/F/G/I, Y181C/I/V/C/H/L, Y188C/H/L, G190A/C/E/Q/S, P225H, F227C/L, M230I/L, P236L, K238N/T and Y318F (virus sensitivity to etravirine) Exclusion Criteria: - Non effective barrier contraception in women of child bearing potential - Pregnant women or women who are breastfeeding - Opportunistic infection at the acute phase - Decompensated cirrhosis (stage B or C of Child-Pugh score) - Malignancy requiring chemotherapy or radiotherapy - Contraindicated medications being taken by the patient (listed in protocol) - Allergy to the active substances and expedients of darunavir, etravirine and raltegravir. --- D30N ---

Primary Outcomes

Measure: Proportion of patients with HIV RNA levels of less than 50 copies/ml in an intent to treat analysis at week 24

Time: week 24

Secondary Outcomes

Measure: Proportions of patients with HIV RNA levels of less than 50 copies/ml at week 48, with HIV RNA levels of less than 400 copies/ml at weeks 24 and 48

Time: week 24 and 48

Measure: HIV RNA level evolution between baseline and week 48

Time: from week 0 to 48

Measure: HIV proviral DNA and 2LTR circle HIV DNA between baseline and week 48

Time: from week 0 to 48

Measure: Number and type of resistance mutations in case of virologic failure occurrence

Time: from week 0 to 48

Measure: CD4 lymphocyte count and proportion evolution between baseline and week 48

Time: from week 0 to 48

Measure: HIV infection progression

Time: from week 0 to 48

Measure: Frequency of the study regimen modifications and interruption

Time: from week 0 to 48

Measure: Study regimen tolerance

Time: from week 0 to 48

Measure: Study regimen adherence

Time: from week 0 to 48

Measure: Association between study drugs' minimum concentrations at week 4 and week 12 and virologic success at week 24

Time: from week 4 to 24

Measure: Evolution of pharmacokinetics parameters of study drugs in the PK substudy

Time: betwwen week 1 and 4

3 Preservation and Expansion of T-cell Subsets Following HAART De-intensification to Atazanavir/Ritonavir (ATV/r) in Adolescents With CD4 + T Cells > 350 Cells/mm3 Initiating HAART

This study proposes to evaluate a pre-DHHS guideline of HAART initiation and then de-intensification management strategy in adolescents with mild immunosuppression and compare changes in CD4% from baseline to week 48 and then during de-intensification.

NCT00491556 HIV Infections Procedure: Early Initiation of Highly Active Anti-Retroviral Therapy Procedure: Standard Care
MeSH: HIV Infections

The following genotypic mutations exclude subjects from participation in ATN 061: Major ATV mutations I50L; I84V; N88D/S, Major PI mutations including: D30N; V32I; L33I/F/V; M46I/L; I47V/A; G48V; I50V/L; I54V/L/A/M/T/S; L76V; V82A/F/T/S/L; L90M, Any major PI mutation as defined by the most current IAS-USA Drug Resistance Mutations Figures that would adversely affect a subject's future PI choices, Major RT mutations: Q151M and 69 insertion complex; Decisions regarding the selection of an NRTI backbone for subjects with NRTI resistance mutations other than those described above will be made by the site PI in consultation with the protocol chair or his designee. --- I50L --- --- I84V --- --- N88D --- --- D30N ---

Primary Outcomes

Measure: Difference in CD4+ T Cell Percentage Between Week 0 and Week 48

Time: Week 0 and Week 48

Measure: Difference in CD4+ T Cell Percentage Between Week 48 and Week 152

Time: 152 Weeks

Secondary Outcomes

Measure: Difference in CD4+ T Cell Count Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD4+ T Cell Count Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD4+ Naïve T Cell Count Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD4+ Naïve T Cell Count Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD4+ Termed Central Memory (TCM) Count Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD4+ TCM Count Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD4+ Effector Memory (TEM)Ro Count Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD4+ TEMRo Count Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD4+ TEMRa Count Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD4+ TEMRa Count Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8+ Naïve T-Cell Count Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8+ Naïve T-Cell Count Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8+ TCM Count Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8+ TCM Count Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8+ TEMRo Count Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8+ TEMRo Count Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8+ TEMRa Count Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8+ TEMRa Count Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 Naïve CD28 Cell Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 Naïve CD28 Cell Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 Naïve CD38 Cell Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 Naïve CD38 Cell Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 Naïve CD57 Cell Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 Naïve CD57 Cell Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 Naïve T-Cell Percentage Expressing Human Leukocyte Antigen-D Related (HLA-DR) Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 Naïve T-Cell Percentage Expressing HLA-DR Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TCM CD28 Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TCM CD28 Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TCM CD38 Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TCM CD38 Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TCM CD57 Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TCM CD57 Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TCM HLA-DR Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TCM HLA-DR Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TEMRo CD28 Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TEMRo CD28 Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TEMRo CD38 Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TEMRo CD38 Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TEMRo CD57 Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TEMRo CD57 Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TEMRO HLADR Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TEMRo HLA-DR Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TEMRa CD28 Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TEMRa CD28 Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TEMRa CD38 Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TEMRa CD38 Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TEMRa CD57 Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TEMRa CD57 Percentage Between Week 48 and Week 152

Time: 152 weeks

Measure: Difference in CD8 TEMRa HLA-DR Percentage Between Week 0 and Week 48

Time: 48 weeks

Measure: Difference in CD8 TEMRa HLA-DR Percentage Between Week 48 and Week 152

Time: 152 weeks

4 Phase 2 Dose-escalating, P-C, D-B, Parallel Group Study in HIV Treatment-experienced Patients to Evaluate the Safety, Tolerability and Efficacy of PA103001-04 Administered as Functional Monotherapy for 14 Days *(PART B)

The purpose of this study is to evaluate antiretroviral activity of up to five different oral doses administered for two weeks of bevirimat versus placebo in HIV treatment experienced patients, who have documented genotypic resistance to at least one major mutation from the IAS-USA list (2007)of resistance mutations for NRTIs, NNRTIs, or PIs. Patients will also be monitored for side effects, and the pharmacokinetics of bevirimat will be determined.

NCT00511368 HIV Infections Drug: matching placebo Drug: Bevirimat
MeSH: HIV Infections

- Have documented evidence of genotypic resistance in their medical records (at screening) or have resistance at screening by genotype to any major mutation from the IAS-USA list of resistance drug mutations, defined as: NRTI resistance: M41L, K65R, D67N, K70R, K70E, L74V, Y115F, M184V, M184V/I, L210W, T215Y/F, K219Q/E; NNRTI resistance: L100I, K103N, V106M, V106A/M, V108I, Y181C, Y181C/I, Y188L, Y188C/L/H, G190S/A, G190A, P225H; Major PI resistance: D30N, V32I, L33F, M46I/L, I47V/A, G48V, I50L, I50V, I54M/L, L76V, V82A/F/T, V82A/F/T/S, V82L/T, I84V, N88S, L90M - Be receiving an antiretroviral therapy regimen containing at least 3 drugs (regimens containing ritonavir must not exceed a total daily dose of 400 mg) which has been unchanged for at least 8 weeks prior to initial screening. --- M41L --- --- K65R --- --- D67N --- --- K70R --- --- K70E --- --- L74V --- --- Y115F --- --- M184V --- --- M184V --- --- L210W --- --- T215Y --- --- K219Q --- --- L100I --- --- K103N --- --- V106M --- --- V106A --- --- V108I --- --- Y181C --- --- Y181C --- --- Y188L --- --- Y188C --- --- G190S --- --- G190A --- --- P225H --- --- D30N ---

Primary Outcomes

Measure: HIV-1 RNA change from baseline over the first 14 days of study

Time: 14 days

Secondary Outcomes

Measure: safety and tolerability; pharmacokinetics

Time: 14 days

5 A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose-response of TMC114/RTV in 3-class-experienced HIV-1 Infected Subjects, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.

The purpose of this study is to determine the antiviral activity, safety and tolerability of TMC114, formulated as an oral tablet, and administered with a low dose of ritonavir

NCT00650832 HIV Drug: TMC114; darunavir; Prezista

Inclusion Criteria: - Patients with documented HIV-1 infection - Patients receiving a PI-containing regimen at screening initiated at least 8 weeks prior to screening with plasma HIV-1 RNA > 1000 copies/mL - Prior use of more than 1 NRTI for at least 3 months in total - Prior use of one or more NNRTIs (investigational included) as part of a failing regimen - Patients having at least 1 primary PI mutation at screening as defined by the IAS guidelines (D30N, M46I/L, G48V, I50V/L, V82A/F/T/S, I84V, L90M)16 - patients experienced to at least one PI for a total period of at least 3 months - Patients voluntarily signs the informed consent form - Patients can comply with the protocol requirements - Patients having a general medical condition that, in the investigator's opinion, does not interfere with the assessments and the completion of the trial. --- D30N ---

Primary Outcomes

Measure: The primary objective of the trial is to compare all TMC114/RTV dose groups with control at Week 24 (the primary endpoint) by means of the confirmed virologic response, defined as a drop in viral load of at least 1 log10 versus baseline.

Secondary Outcomes

Measure: To evaluate safety and tolerability over 24 to 144 weeks; To evaluate the durability of the antiviral activity; To investigate the dose-response by comparing the different TMC114/RTV dosages.

6 A Pilot Trial Evaluating Maintenance Therapy With Lamivudine(Epivir®) and Dolutegravir(Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol

The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected patients virologically suppressed with triple HAART.

NCT02527096 HIV-1 Infection Drug: dolutegravir (Tivicay®) - Phase 1 Drug: lamivudine (Epivir®) - Phase 2 Drug: dolutegravir (Tivicay®) - Phase 2
MeSH: Acquired Immunodeficiency Syndrome HIV Infections

Inclusion Criteria: - HIV-1 infected patient - Age ≥ 18 years - CD4 cell count nadir > 200/mm3 - Genotype on pre-HAART interpreted with the last version of the ANRS AC11 resistance group's algorithm which presents: - no major mutation on protease among: D30N, V32I, M46I/L, I47A/V, G48V, I50L/V, 154M/L, L76V, V82A/F/T/S, I84V, N88D/S, L90M,- no mutation on RT (except the mutation A98S if the patient is not infected by the virus subtype C), - no mutation on integrase (if the genotype is available), - First-line treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, 1 NNRTI or 1 INI). --- D30N ---

Primary Outcomes

Description: Virological failure is defined by plasma HIV RNA > 50 cp/mL on 2 following samples at 2 to 4 weeks apart.

Measure: Virological success without any intercurrent event leading to interrupt the strategy of the trial (analysis)

Time: from week 8 to week 56 (± 4 weeks)

Secondary Outcomes

Description: Evaluation was calculated as the CD4 count at the corresponding week minus the baseline CD4 count

Measure: Evolution of CD4 and CD8 lymphocytes count (analysis)

Time: from week 8 to week 32 and week 56

Measure: Percentage of participants who discontinued the strategy of the trial for toxicity or with adverse event of grade 3 or 4 (analysis)

Time: week 56

Measure: Profile of resistance mutations in plasma in case of virological failure

Time: week 56

Measure: Percentage of participants with plasma HIV RNA < 1 cp/mL

Time: Day 0, week 8, week 32 and week 56

Description: Influence of total DNA at Day 0 on the occurrence of virological failure or blip

Measure: Influence of total DNA on the occurrence of virological failure or blip

Time: from Day 0 to week 56

Measure: Measure of concentrations of dolutegravir(Tivicay®) and lamivudine(Epivir®) in case of virological failure or with a blip

Time: week 56

Measure: Measure of adherence to treatment (self-reported)

Time: Day 0, week 4, week 8, week 32 and week 56

Measure: Measure of quality of life (self-reported)

Time: Day 0, week 8 and week 56

Description: Evaluation of medico-economic aspects. Evaluate the direct medical cost related to dolutegravir and lamivudine versus the cost of the previous treatment.

Measure: Comparison of Medico-economic substudy (analysis)

Time: week 56

Description: Measure of concentrations of dolutegravir and NRTI, and HIV RNA in semen at Week 8 and Week 32 in a subgroup of 20 participants

Measure: Sperm substudy measure of concentration

Time: Week 8 and week 32


HPO Nodes