Phase 2
Completed N=192
Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection
Source: ClinicalTrials.gov NCT00445146 ↗Enrolled (actual)
192
Serious AEs
44.8%
Results posted
Apr 2016
Primary outcomePrimary: Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event — 14.6 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Any Treatment-Emergent Study Dug-Related Adverse Event |
14.6 | — |
| SECONDARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events |
93.8; 45.3; 3.1; 44.8 | — |
| SECONDARY Percentage of Participants Experiencing Any Treatment-Emergent Laboratory Abnormality |
18.3; 31.9; 35.1; 14.1 | — |
| SECONDARY Percentage of Participants Experiencing Any Marked Treatment-Emergent Laboratory Abnormality |
40.3 | — |
| SECONDARY Hemoglobin at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
14.2; 0.1; 0.3; 0.2; 0.2; 0.3 | — |
| SECONDARY Red Blood Cell (RBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
4.6; 0.0; 0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY White Blood Cell (WBC) Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
5.64; 0.02; 0.12; -0.17; -0.25; -0.19 | — |
| SECONDARY Platelet Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
226; 2; 5; 13; 3; -2 | — |
| SECONDARY Alkaline Phosphatase at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
101; -6; -9; -9; -13; -18 | — |
| SECONDARY Alanine Aminotransferase (ALT) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
28; 2; 1; 2; 2; 1 | — |
| SECONDARY Aspartate Aminotransferase (AST) at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
29; 2; 0; 2; 1; -1 | — |
| SECONDARY HIV-1 RNA at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
2.70; -0.13; -0.20; -0.11; -0.22; -0.21 | — |
| SECONDARY 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 |
65.3; 69.7; 78.6; 76.8; 82.9; 84.5 | — |
| SECONDARY 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 |
44.2; 56.0; 62.9; 65.5; 73.2; 79.1 | — |
| SECONDARY CD4 Cell Count at Baseline and Change From Baseline at Weeks 24, 48, 96, 144, 192, 240, 288, 336, and 384 |
283; 22; 38; 78; 126; 149 | — |
| SECONDARY Incidence of Mortality |
6.8 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00445146). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.