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Report for Clinical Trial NCT02770508

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 4, Randomized, Open Label, Controlled Study of Boosted Darunavir and Lamivudine Versus Boosted Darunavir and Emtricitabine/Tenofovir or Lamivudine/Tenofovir in Naïve HIV-1 Infected Subjects

The purpose of this study is to compare the safety and efficacy of a combination of a QD regimen consisting on ritonavir boosted darunavir (FDC) and lamivudine versus ritonavir boosted darunavir (FDC) plus co-formulated tenofovir and emtricitabine or co-formulated tenofovir/lamivudine in naïve HIV-1 infected patients. Subjects will be ARV-naïve HIV-1-infected patients eligible to start ARV therapy according to current guidelines.Subjects will be adults ≥ 18 years of age who meet all of the inclusion criteria and none of the exclusion criteria.

NCT02770508 HIV-1 Infection

3 Interventions

Name: darunavir/ritonavir

Type: Drug
Group Labels: 2

Darunavir/ritonavir plus emtricitabine/tenofovir(FTC/TFD) Darunavir/ritonavir plus lamivudine

Name: Lamivudine

Type: Drug
Group Labels: 1

Darunavir/ritonavir plus lamivudine

Name: emtricitabine-tenofovir(FTC/TDF)

Type: Drug
Group Labels: 1

Darunavir/ritonavir plus emtricitabine/tenofovir(FTC/TFD)


Primary Outcomes

Description: The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) <50 c/mL at Week 48 will be assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, Otherwise, virologic success or failure will be determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks).

Measure: Percentage of patients with HIV-1 RNA levels of less than 50 copies/mL at week 48

Time: 48 weeks

Secondary Outcomes

Description: The percentage of participants with Plasma Human Immunodeficiency Virus-1 (HIV-1) <400 c/mL at Week 24 will be assessed using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm.

Measure: Percentage of patients with HIV-1 RNA <400 copies/mL at week 24

Time: 24 weeks

Description: An genotiping test will be made at time to virological failure to detect mutation across reverse transcriptase (RT), and Protease (PRO). Protocol defined virological failure was defined as confirmed plasma HIV-1 RNA levels >=400 copies/mL on or after Week 24 or confirmed plasma HIV-1 RNA levels >=50 copies/mL at week 48

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

Time: from week 24 to week 48

Description: Change from Baseline in CD4+ cell counts will be assessed at Weeks 24 and 48.

Measure: CD4+ lymphocyte count and change between baseline (defined as the average between screening and baseline visit values) and weeks 24 and 48

Time: week 24 and 48

Description: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

Measure: Frequency, type and severity of adverse events and laboratory abnormalities.

Time: week 24 and 48

Description: Clinical disease progression (CDP) was assessed according to the Centers for Disease Control and Prevention (CDC) HIV-1 classification system. Category (CAT) A: one or more of the following conditions (CON), without any CON listed in Categories B and C: asymptomatic HIV infection, persistent generalized lymphadenopathy, acute (primary) HIV infection with accompanying illness or history of acute HIV infection. CAT B: symptomatic CON that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or that are considered by physicians to have a clinical course or to require management that is complicated by HIV infection; and not included among CON listed in clinical CAT C. CAT C: the clinical CON listed in the AIDS surveillance case definition. Indicators of CDP were defined as: CDC CAT A at Baseline (BS) to a CDC CAT C event (EV); CDC CAT B at BS to a CDC CAT C EV; CDC CAT C at BS to a new CDC CAT C EV; or CDC CAT A, B, or C at BS to death.

Measure: Clinical disease progression (CDP)

Time: week 24 and 48

Description: The evaluation of quality of life will be done through two validated instruments: the Medical Outcomes Study HIV Health Survey ( MOS - HIV) and EuroQol 5D (EQ - 5D ) . Both instruments will be administered to patients at baseline , week 24 and week 48 .

Measure: Changes in quality of life

Time: baseline, week 24 and week 48

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 16 SNPs

SNPs


1 I47V

Any of the following mutations will be considered resistance to DRV/r : - I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V. --- I47V ---


2 I50V

Any of the following mutations will be considered resistance to DRV/r : - I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V. --- I47V --- --- I50V ---


3 I54M

Any of the following mutations will be considered resistance to DRV/r : - I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V. --- I47V --- --- I50V --- --- I54M ---


4 I84V

Any of the following mutations will be considered resistance to DRV/r : - I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V. --- I47V --- --- I50V --- --- I54M --- --- L76V --- --- I84V ---


5 K65R

- Any of the following mutations will be considered resistance to 3TC or FTC : M184V/I and /or K65R and / or Q151M. --- M184V --- --- K65R ---

- Any of the following mutations will be considered resistance to TDF: K65R, K70E, double insertion 69 or 3 TAMS including M41L or L210W. --- K65R ---


6 K70E

- Any of the following mutations will be considered resistance to TDF: K65R, K70E, double insertion 69 or 3 TAMS including M41L or L210W. --- K65R --- --- K70E ---


7 L210W

- Any of the following mutations will be considered resistance to TDF: K65R, K70E, double insertion 69 or 3 TAMS including M41L or L210W. --- K65R --- --- K70E --- --- M41L --- --- L210W ---


8 L33F

Any of the following mutations will be considered resistance to DRV/r : - I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V. --- I47V --- --- I50V --- --- I54M --- --- L76V --- --- I84V --- --- V11I --- --- V32I --- --- L33F ---


9 L76V

Any of the following mutations will be considered resistance to DRV/r : - I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V. --- I47V --- --- I50V --- --- I54M --- --- L76V ---


10 L89V

Any of the following mutations will be considered resistance to DRV/r : - I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V. --- I47V --- --- I50V --- --- I54M --- --- L76V --- --- I84V --- --- V11I --- --- V32I --- --- L33F --- --- T74P --- --- L89V ---


11 M184V

- Any of the following mutations will be considered resistance to 3TC or FTC : M184V/I and /or K65R and / or Q151M. --- M184V ---


12 M41L

- Any of the following mutations will be considered resistance to TDF: K65R, K70E, double insertion 69 or 3 TAMS including M41L or L210W. --- K65R --- --- K70E --- --- M41L ---


13 Q151M

- Any of the following mutations will be considered resistance to 3TC or FTC : M184V/I and /or K65R and / or Q151M. --- M184V --- --- K65R --- --- Q151M ---


14 T74P

Any of the following mutations will be considered resistance to DRV/r : - I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V. --- I47V --- --- I50V --- --- I54M --- --- L76V --- --- I84V --- --- V11I --- --- V32I --- --- L33F --- --- T74P ---


15 V11I

Any of the following mutations will be considered resistance to DRV/r : - I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V. --- I47V --- --- I50V --- --- I54M --- --- L76V --- --- I84V --- --- V11I ---


16 V32I

Any of the following mutations will be considered resistance to DRV/r : - I47V, I50V, I54M/L, L76V, I84V or, 3 or more minor mutations : V11I, V32I, L33F, T74P, L89V. --- I47V --- --- I50V --- --- I54M --- --- L76V --- --- I84V --- --- V11I --- --- V32I ---



HPO Nodes