Phase 2
N=79
Vicriviroc (SCH 417690) Treatment Protocol in Human Immunodeficiency Virus (HIV)-Infected Participants: A Rollover Study for ACTG Protocol A5211 (P04100)
HIV · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00686829 ↗Enrolled (actual)
79
Serious AEs
48.1%
Results posted
Dec 2020
Primary outcome: Primary: Percentage of Participants With ≥1 Adverse Events (AEs) — 91 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vicriviroc maleate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With ≥1 Adverse Events (AEs) |
91 | — |
| PRIMARY Percentage of Participants Discontinuing Study Therapy Due to AEs |
6 | — |
| PRIMARY Percentage of Participants With ≥1 Serious Adverse Events (SAEs) |
48 | — |
| PRIMARY Percentage of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL |
52; 64; 80; 89; 80 | — |
| PRIMARY Percentage of Participants With HIV RNA >50 to <400 Copies/mL |
13; 11; 12; 2; 15 | — |
| PRIMARY Percentage of Participants With HIV RNA ≥400 Copies/mL |
35; 25; 8; 9; 5 | — |
| PRIMARY Number of Participants With Coreceptor Tropism Shifts From Baseline |
45; 10; 5; 11; 3; 1 | — |
| PRIMARY Mean Change From Baseline in CD4/CD8 Cell Counts |
-16.26; -17.70; 9.30; -0.20; 12.59; -13.81 | — |
| PRIMARY Number of Participants With Reduced Susceptibility to VCV |
7 | — |
| PRIMARY Number of Participants With AIDS-defining Events (ADEs) |
1; 1 | — |
| PRIMARY Number of Participants With New Infections |
6; 39 | — |
Summary
The purpose of this study is to provide open-label vicriviroc (VCV) to human immunodeficiency virus (HIV) treatment-experienced participants who successfully completed 48 weeks of treatment on Acquired Immunodeficiency Syndrome (AIDS) Clinical Trial Group (ACTG) protocol A5211 (or who responded favorably to treatment but discontinued participation due to viral tropism shifts), and participants who screened for ACTG A5211 and met all inclusion/exclusion criteria, but were unable to enroll due to protocol closure.
Eligibility Criteria
Inclusion Criteria
- Successful completion of ACTG Protocol A5211, or favorable response in A5211 but discontinued due to tropism shift, or screened for A5211 and met inclusion/exclusion criteria but unable to enroll due to protocol closure.
- Participants must also be on a ritonavir-containing antiretroviral regimen at entry, and have acceptable hematologic and laboratory parameters.
- Female participants of reproductive potential must agree to use 2 reliable methods of contraception, including a barrier method, and must have a negative urine pregnancy test prior to dosing.
Exclusion Criteria
- History of seizure or drug use that increases risk of seizure, current use of CYP3A4 inducers, prior history of malignancy, active drug or alcohol use or dependence that would interfere with study requirements
- Female participants who are breast-feeding, pregnant, or plan to become pregnant
- Participation in a clinical trial with another investigational drug.
- Participants with serious illness requiring systemic therapy and/or hospitalization must not begin VCV (if not already on VCV) until participant completes therapy or is clinically stable on therapy for at least 14 days prior to enrollment.
Data sourced from ClinicalTrials.gov (NCT00686829). 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.