Phase 2
N=116
Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Participants (VICTOR-E1) (MK-7690-020/P03672)
HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT00243230 ↗Enrolled (actual)
116
Serious AEs
13.6%
Results posted
Jun 2021
Primary outcome: Primary: Change From Baseline in Log10 Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Week 48 of the Double-blind Period — 4.52; 4.50; 4.62; -1.78 Log10 copies/mL — p=0.0017
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Vicriviroc 30 mg (Drug); Vicriviroc 20 mg (Drug); Placebo (Drug); Background ART Regimen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Oct 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Log10 Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) at Week 48 of the Double-blind Period |
4.52; 4.50; 4.62; -1.78; -1.73; -0.80 | 0.0017 sig |
| SECONDARY Participants With ≥1.0 log10 Change From Baseline HIV RNA at Week 48 of the Double-blind Period |
26; 25; 12 | 0.0052 sig |
| SECONDARY Participants With HIV RNA <400 Copies/mL at Week 48 of the Double-blind Period |
25; 24; 9 | 0.0007 sig |
| SECONDARY Participants With a Time to Loss of Virologic Response (TLOVR) Based on 0.5 Log10 Reduction by 48 Weeks of the Double-blind Period |
31; 32; 15; 1; 1; 1 | — |
| SECONDARY Change From Baseline in Log10 HIV RNA at Week 12 of the Double-blind Period |
4.52; 4.50; 4.62; -2.11; -1.94; -1.11 | 0.0002 sig |
| SECONDARY Change From Baseline in Log10 HIV RNA at Week 24 of the Double-blind Period |
4.52; 4.50; 4.62; -2.07; -2.04; -0.96 | 0.0003 sig |
| SECONDARY Change From Baseline CD4 Cells Count at Week 12 of the Double-blind Period |
202.23; 202.10; 214.41; 109.85; 94.46; 52.09 | 0.0264 sig |
| SECONDARY Change From Baseline CD4 Count at Week 24 of the Double-blind Period |
202.23; 202.10; 214.41; 97.58; 103.58; 59.46 | 0.1525 |
| SECONDARY Change From Baseline CD4 Count at Week 48 of the Double-blind Period |
202.23; 202.10; 214.41; 102.12; 133.88; 64.80 | 0.2603 |
| SECONDARY Change From Baseline CD4 Count at Month 42 of the Open Label Extension |
366.16; -78.67 | — |
| SECONDARY Participants With <400 Copies/mL HIV RNA at Week 12 of the Double-blind Period |
28; 25; 14 | 0.0031 sig |
| SECONDARY Participants With <400 Copies/mL HIV RNA at Week 24 of the Double-blind Period |
28; 29; 12 | 0.0009 sig |
| SECONDARY Number of Participants With <50, 50 to <400, and ≥400 Copies/mL HIV RNA of the Open Label Extension |
48; 42; 5; 1; 10; 5 | — |
| SECONDARY Participants With <50 Copies/mL HIV RNA at Week 12 of the Double-blind Period |
18; 17; 8 | 0.0225 sig |
| SECONDARY Participants With <50 Copies/mL HIV RNA at Week 24 of the Double-blind Period |
25; 23; 9 | 0.0009 sig |
| SECONDARY Participants With <50 Copies/mL HIV RNA at Week 48 of the Double-blind Period |
22; 21; 5 | 0.0002 sig |
| SECONDARY Participants With Acquired Immunodeficiency Syndrome (AIDS)-Defining Events of the Double-blind Period |
0; 0; 1 | — |
| SECONDARY Participants With AIDS-defining Events of the Open Label Extension |
1 | — |
| SECONDARY Time to Occurrence of an AIDS-defining Event of the Double-blind Period |
256 | — |
| SECONDARY Observed Minimum Serum Concentration of Vicriviroc (Cmin) of the Double-blind Period |
206.56; 156.95 | — |
| SECONDARY Observed Maximum (Peak) Plasma Concentration of Vicriviroc (Cmax) of the Double-blind Period |
316.21; 229.33 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve of Vicriviroc (AUC) of the Double-blind Period |
5795.62; 4314.88 | — |
| SECONDARY Participants With Detectable Vicriviroc Resistance of the Double-blind Period |
1; 4; 0 | — |
| SECONDARY Participants With Detectable C-X-C Chemokine Receptor Type 4 (CXCR4)-Tropic Virus of the Double-blind Period |
9; 7; 3; 8; 7; 2 | — |
| SECONDARY Participants With Detectable CXCR4-Tropic Virus and Immune Decline (≥50% Fall in CD4 Count From Baseline) of the Double-blind Period |
3; 1; 2; 3; 1; 0 | — |
Summary
Vicriviroc (vye-kri-VYE-rock) is an investigational drug that belongs to a new class of drugs, called C-C chemokine receptor type 5 (CCR5) receptor blockers. This group of drugs blocks one of the ways human immunodeficiency virus (HIV) enters T-cells (the cells that fight infection). The purpose of this 48-week study is to evaluate 2 dose levels of vicriviroc in participants with HIV who have not responded adequately to standard HIV treatments. This study was designed to evaluate the safety and efficacy of doses of vicriviroc, when taken in combination with other HIV drugs, in terms of ability to decrease the level of HIV (viral load) in the blood. The primary objective of the study was to evaluate antiviral efficacy of two doses of Vicriviroc maleate compared to placebo in combination with a protease inhibitor (PI)-containing optimized antiretroviral therapy (ART) regimen in CCR5-tropic HIV infected individuals failing a standard ART regimen.
Eligibility Criteria
Inclusion Criteria
- Adult participants with documented HIV infection with no detectable C-X-C Motif Chemokine Receptor 4 (CXCR4)
- Prior therapy for ≥3 months with ≥3 classes of currently marketed (US FDA-approved) antiretroviral agents (nucleoside reverse transcriptase inhibitor, NRTIs, non-nucleoside reverse transcriptase inhibitor (NNRTIs), protease inhibitor (PIs), or fusion inhibitors) at any time prior to screening
- HIV ribonucleic acid (RNA) ≥1000 copies/mL on a stable ART regimen for ≥6 weeks prior to Screening and ≥8 weeks prior to randomization
- ≥1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and ≥1 primary resistance mutation to a PI
- Acceptable hematologic, renal and hepatic laboratory parameters
Exclusion Criteria
- No history of previous malignancy (with the exceptions of cutaneous Kaposi's Sarcoma without visceral or mucosal involvement that resolved with highly active antiretroviral therapy (HAART) but without systemic anti-cancer treatment, and basal-cell carcinoma of skin surgically resected with disease-free margins on pathology exam)
- Treatment with cytotoxic cancer chemotherapy,
- Recurrent seizure, or central nervous system (CNS) condition or drug use predisposing to seizure in the opinion of the investigator
- No active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection
Data sourced from ClinicalTrials.gov (NCT00243230). 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.