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Report for Clinical Trial NCT00362687

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

GMB: Phase IV, Multicenter, Randomized, Open-Label Pilot Study of Truvada (TDF+FTC) or Emtricitabine (FTC) Alone Versus HAART Interruption in HIV-Infected Patients Who Need to Interrupt HAART and Who Are Infected With HIV Isolates Containing at Least 2 TAMs (or K65R) and M184V

Many patients who already harbor drug-resistant HIV require interruption of HAART due to poor compliance, poor quality of life, toxicity or development of resistance. In these patients interruption of HAART has a negative impact on patient immune status due to the reemergence of wild-type virus which is in general more pathogenic than HIV isolates containing resistance mutations. There is a need for "bridging" antiretroviral regimens that might prolong time off conventional HAART whilst waiting for a new regimen that is either fully suppressive or less toxic or less demanding for the patient.

NCT00362687 HIV Infections
MeSH:HIV Infections

3 Interventions

Name: Truvada (TDF+FTC) alone

Description: tenofovir DF 300 mg and emtricitabine 200 mg in a fixed dose tablet formulation
Type: Drug
Group Labels: 1

1

Name: FTC alone

Description: emtricitabine 200 mg
Type: Drug
Group Labels: 1

2

Name: No HAART

Description: No HAART
Type: Procedure
Group Labels: 2

1 2


Primary Outcomes

Measure: To compare CD4 cell loses 24 weeks after HAART discontinuation

Time: Through 48 weeks

Secondary Outcomes

Measure: Proportion of patients with re-initiation of HAART within 24 and 48 weeks

Time: Through 48 weeks

Measure: To compare CD4 cell loses 48 weeks after HAART discontinuation

Time: Through 48 weeks

Measure: To compare HIV viral loads 4, 24 and 48 weeks after HAART discontinuation:time-weighted average change from baseline through 24 and 48 weeks (DAVG24 and DAVG48) for log10 plasma HIV-1 RNA for patients with plasma HIV-1 RNA >50 copies/mL at baseline

Time: Through 48 weeks

Measure: To compare HIV viral loads 4, 24 and 48 weeks after HAART discontinuation: time-weighted average change from 4 weeks through 24 and 48 weeks (DAVG24 and DAVG48) for log10 plasma HIV-1 RNA for patients with <50 copies/mL at baseline

Time: Through 48 weeks

Measure: To compare HIV viral loads 4, 24 and 48 weeks after HAART discontinuation: proportion of patients with HIV RNA <400 and <50 copies/mL at 4 weeks for subjects with plasma HIV-1 RNA <50 copies/mL at baseline

Time: Through 48 weeks

Measure: To compare HIV viral loads 4, 24 and 48 weeks after HAART discontinuation: compare log10 plasma HIV-1 RNA at week 4 for patients with HIV-RNA < 50 copies/mL at baseline.

Time: Through 48 weeks

Measure: To compare development of new mutations in the reverse transcriptase gene 24 and 48 weeks after HAART discontinuation.

Time: Through 48 weeks

Measure: Proportion of patients with any adverse event.

Time: Through 48 weeks

Measure: Proportion of patients for each adverse event.

Time: Through 48 weeks

Measure: Distribution of the intensity if each adverse event (the greatest intensity for each adverse event within a patient will be considered).

Time: Through 48 weeks

Measure: Distribution of the relationship between the adverse effect and the study drug (the strongest relation with the study drug for each adverse event within each patient will be considered).

Time: Through 48 weeks

Measure: Proportion of patients who discontinue the study prematurely (before week 48)due to adverse events.

Time: Through 48 weeks

Measure: Changes in patient's quality of life analyses.

Time: Through 48 weeks

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 K65R

GMB: Phase IV, Multicenter, Randomized, Open-Label Pilot Study of Truvada (TDF+FTC) or Emtricitabine (FTC) Alone Versus HAART Interruption in HIV-Infected Patients Who Need to Interrupt HAART and Who Are Infected With HIV Isolates Containing at Least 2 TAMs (or K65R) and M184V. --- K65R ---

- Available genotype (current or historical) showing M184V and (≥ 2 TAMs or K65R). --- M184V --- --- K65R ---


2 M184V

GMB: Phase IV, Multicenter, Randomized, Open-Label Pilot Study of Truvada (TDF+FTC) or Emtricitabine (FTC) Alone Versus HAART Interruption in HIV-Infected Patients Who Need to Interrupt HAART and Who Are Infected With HIV Isolates Containing at Least 2 TAMs (or K65R) and M184V. --- K65R --- --- M184V ---

- Available genotype (current or historical) showing M184V and (≥ 2 TAMs or K65R). --- M184V ---



HPO Nodes