Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection
- Registration Number
- NCT00445146
- Lead Sponsor
- Gilead Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 192
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EVG+RTV ARV regimen 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. EVG+RTV EVG 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. EVG+RTV RTV 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event Up to Week 408 plus 30 days
- Secondary Outcome Measures
Name Time Method 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 Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality Up to Week 408 plus 30 days 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.
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 Percentage of Participants Experiencing Treatment-Emergent Adverse Events Up to Week 408 plus 30 days 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.
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 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 Experiencing Any Marked Treatment-Emergent Laboratory Abnormality Up to Week 408 plus 30 days 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.
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 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 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 < 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 Up to Week 408 plus 30 days The percentage of participants who died was summarized.