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Report for Clinical Trial NCT00708162

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Ritonavir-Boosted Elvitegravir (EVG/r) Versus Raltegravir (RAL) Each Administered With a Background Regimen in HIV-1 Infected, Antiretroviral Treatment-Experienced Adults

The purpose of this study is to compare the safety, tolerability and efficacy of a regimen containing once-daily elvitegravir (EVG) versus twice-daily raltegravir (RAL) added to a background regimen (1 fully-active ritonavir (RTV)-boosted protease inhibitor (PI) plus 1 or 2 additional antiretroviral (ARV) agents) in HIV-1 infected, ARV treatment-experienced adults who have documented resistance, or at least six months experience prior to screening with two or more different classes of ARV agents. Participants will be randomized in a 1:1 ratio to receive EVG plus background regimen (Elvitegravir group), or raltegravir plus background regimen (Raltegravir group). Due to known drug interactions, participants in the Elvitegravir group receiving RTV-boosted atazanavir (ATV) or RTV-boosted lopinavir (LPV) as part of their background regimen will receive elvitegravir at a lower dose (85 mg).

NCT00708162 HIV Infection
MeSH: HIV Infections

5 Interventions

Name: Elvitegravir

Description: Elvitegravir (EVG) tablet administered orally once daily with food

Type: Drug

Elvitegravir

Name: Raltegravir

Description: Raltegravir tablet administered orally twice daily according to prescribing information

Type: Drug

Raltegravir

Name: EVG placebo

Description: Placebo to match elvitegravir administered orally once daily

Type: Drug

Raltegravir

Name: RAL placebo

Description: RAL placebo administered orally twice daily.

Type: Drug

Elvitegravir

Name: Background regimen

Description: Background Regimen (administered according to prescribing information) contains 1 fully-active ritonavir-boosted protease inhibitor (PI/r) plus 1 or 2 additional agents. The ritonavir-boosted PIs include either ATV, darunavir, fosamprenavir, LPV (Kaletra®), or tipranavir; the additional agents include abacavir (ABC), Combivir® (lamivudine (LAM)/zidovudine (ZDV) coformulated), didanosine, emtricitabine (FTC), enfuvirtide, Epzicom® (ABC/LAM coformulated), etravirine, LAM, maraviroc, tenofovir disoproxil fumarate (TDF), Truvada®, (FTC/TDF coformulated), and/or ZDV.

Type: Drug

Elvitegravir Raltegravir


Primary Outcomes

Description: The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA-defined Time to Loss of Virologic Response (TLOVR) algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

Measure: Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48

Time: Week 48

Secondary Outcomes

Description: The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

Measure: Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 96

Time: Week 96

Description: The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

Measure: Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 48

Time: Week 48

Description: The percentage of participants achieving and maintaining confirmed HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the FDA-defined TLOVR algorithm, which takes into account a patient's longitudinal viral load up to the predefined time point by considering patterns of suppression and rebounding.

Measure: Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 400 Copies/mL at Week 96

Time: Week 96

Description: Virologic response at Week 48 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.

Measure: Virologic Response at Week 48 (HIV-1 RNA < 50 Copies/mL)

Time: Week 48

Description: Virologic response at Week 96 (percentage of participants with HIV-1 RNA < 50 copies/mL) was analyzed using the FDA-defined Snapshot algorithm, which defines a patient's virologic response status using the viral load along with study drug discontinuation status at the predefined time point within an allowed window of time.

Measure: Virologic Response at Week 96 (HIV-1 RNA < 50 Copies/mL)

Time: Week 96

Description: The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.

Measure: Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 48

Time: Baseline to Week 48

Description: The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 50 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.

Measure: Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 50 Copies/mL) up to Week 96

Time: Baseline to Week 96

Description: The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 48 was estimated using the Kaplan-Meier method in the time to event analysis.

Measure: Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 48

Time: Baseline to Week 48

Description: The percentage of participants with pure virologic failure (HIV-1 RNA cutoff at 400 copies/mL) up to Week 96 was estimated using the Kaplan-Meier method in the time to event analysis.

Measure: Percentage of Participants With Pure Virologic Failure (HIV-1 RNA Cutoff at 400 Copies/mL) up to Week 96

Time: Baseline to Week 96

Description: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the missing = failure method, where participants with missing data were considered as having failed to meet the criteria for evaluation.

Measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48

Time: Week 48

Description: The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 96 was analyzed using the missing = failure method.

Measure: Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96

Time: Week 96

Description: The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48 was analyzed using the missing = failure method.

Measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48

Time: Week 48

Description: The percentage of participants with HIV-1 RNA < 400 copies/mL at Week 96 was analyzed using the missing = failure method.

Measure: Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96

Time: Week 96

Description: The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 48 was analyzed.

Measure: Change From Baseline in HIV-1 RNA at Week 48

Time: Baseline to Week 48

Description: The change from baseline in log10 HIV-1 RNA (copies/mL) at Week 96 was analyzed.

Measure: Change From Baseline in HIV-1 RNA at Week 96

Time: Baseline to Week 96

Description: The change from baseline in CD4 cell count (cells/mm^3) at Week 48 was analyzed.

Measure: Change From Baseline in CD4 Cell Count at Week 48

Time: Baseline to Week 48

Description: The change from baseline in CD4 cell count (cells/mm^3) at Week 96 was analyzed.

Measure: Change From Baseline in CD4 Cell Count at Week 96

Time: Baseline to Week 96

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 M184V

If the M184V/I reverse transcriptase (RT) mutation is present on the screening genotype report and an NRTI is used as the second agent, then either FTC or LAM may be added as a third agent in the background regimen to maintain the M184V/I mutation. --- M184V ---

If the M184V/I reverse transcriptase (RT) mutation is present on the screening genotype report and an NRTI is used as the second agent, then either FTC or LAM may be added as a third agent in the background regimen to maintain the M184V/I mutation. --- M184V --- --- M184V ---



HPO Nodes