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Report for Clinical Trial NCT00362687
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
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
3 Interventions
Name: Truvada (TDF+FTC) alone
Description: tenofovir DF 300 mg and emtricitabine 200 mg in a fixed dose tablet formulation
Type: Drug
Name: FTC alone
Description: emtricitabine 200 mg
Type: Drug
Name: No HAART
Description: No HAART
Type: Procedure
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
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 ---
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 ---