Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

Study Overview
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Brief Summary
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The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.

Official Title
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A Phase 2, Open-Label, Multicenter Study of the Safety of Ritonavir-Boosted GS-9137 (GS-9137/r) Administered in Combination With Other Antiretroviral Agents for the Treatment of HIV-1 Infected Subjects

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: EVG
* Drug: RTV
* Drug: ARV regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Completion of a prior EVG+RTV treatment study without treatment-limiting toxicity. Males and females of childbearing potential must agree to utilize effective contraception methods. Ability to understand and sign a written informed consent form. Exclusion Criteria: Females who are pregnant or breastfeeding. Participation in any other clinical trial without prior approval from the Sponsor. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study. Subjects receiving ongoing therapy with contraindicated drugs.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EVG+RTV<br>EVG 85 mg or 150 mg + RTV + ARV regimen Participants receiving lopinavir/ritonavir (LPV/r) or atazanavir/ritonavir (ATV/r) as part of their ARV regimen will receive EVG 85 mg and all other participants will receive EVG 150 mg. Some participants may receive EVG 300 mg during the course of protocol amendment 2. | Drug: EVG<br>* Elvitegravir (EVG) tablet administered orally once daily with food<br>* Other names: GS-9137;Drug: RTV<br>* Ritonavir (RTV; /r) 100 mg capsule administered orally once daily with food<br>* Other names: Norvir®;Drug: ARV regimen<br>* The components of the ARV regimen will be selected by the investigator without input from the sponsor. The antiretroviral regimen must consist of at least 2 agents, not including the non-nucleoside reverse transcriptase inhibitors (NNRTIs) efavirenz, nevirapine, or delavirdine; the protease inhibitors saquinavir, nelfinavir, or indinavir; or investigational agents (without sponsor approval).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event |  | Up to Week 408 plus 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Adverse events (AEs) occurring during treatment and for 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event. | Up to Week 408 plus 30 days | 
| Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. | Up to Week 408 plus 30 days | 
| Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality | A 'marked abnormality' was defined as a shift from grade 0 (or missing) at baseline to at least grade 3 postbaseline; or grade 1 at baseline to grade 4 postbaseline. | Up to Week 408 plus 30 days | 
| Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Baseline and at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |  | Baseline; Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 | 
| Incidence of Mortality | The percentage of participants who died was summarized. | Up to Week 408 plus 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 2, Open-label, Rollover, Integrase Inhibitor, Antiretroviral Agents, Highly Active Antiretroviral Activity, HAART, HIV, HIV-1, AIDS virus, Human Immunodeficiency Virus, Acquired Immune Deficiency Syndrome Virus, treatment experienced