Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00523211 | Vicriviroc in HIV-Treatment Experienced Subjects (Study P04405AM5) | PHASE3 | COMPLETED | 506 | — | — | Jul 1, 2007 | Mar 1, 2011 | Sep 25, 2015 | - | — |
| NCT00474370 | Vicriviroc in HIV-Treatment Experienced Subjects (Study P04889AM8)(COMPLETED) | PHASE3 | COMPLETED | 400 | — | — | May 15, 2007 | Oct 26, 2010 | Aug 30, 2022 | - | — |
| NCT00551018 | Efficacy and Safety of VICRIVIROC in HIV-Infected Treatment-Naïve Subjects (Study P04875) | PHASE2 | COMPLETED | 218 | — | — | Dec 1, 2007 | Oct 1, 2010 | Feb 6, 2015 | - | — |
| NCT00551330 | Vicriviroc in HIV(R5/X4)-Treatment Experienced Subjects (Study P05057AM5)(COMPLETED) | PHASE2 | COMPLETED | 111 | — | — | Sep 1, 2007 | May 1, 2010 | Dec 21, 2015 | - | — |
| NCT00243230 | Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Participants (VICTOR-E1) (MK-7690-020/P03672) | PHASE2 | COMPLETED | 116 | — | — | Sep 19, 2005 | Mar 17, 2011 | Jun 8, 2021 | - | — |
| NCT00632073 | Effect of Vicriviroc on HIV Ribonucleic Acid (RNA) Levels in Cerebrospinal Fluid (Study P05241) | PHASE1 | COMPLETED | 13 | — | — | Mar 1, 2008 | Mar 1, 2010 | Feb 23, 2015 | - | — |
HIV RNA was measured by AMPLICOR HIV-1 MONITOR Standard assay. For participants who had HIV RNA below the lower quantification of the Standard assay (LOQ of 400 copies/mL), the AMPLICOR HIV-1.5 UltraSensitive assay was performed. If the HIV RNA measurement was below the lower quantification of the UltraSensitive assay (LOQ of 50 copies/mL), a value of 49 was imputed. If a continuing participant has a missing HIV RNA value at the time point of interest, the geometric mean of immediately preceding and following values was used. If the participants had no subsequent following value or discontinued study treatment before the time point of interest, then the change from baseline was set to zero. Analysis was performed with a variance (ANOVA) model that adjusted for the treatment and stratification factors (intended enfuvirtide (T20) use in current newly-optimized background regimen (OBT) (Y/N) and HIV RNA at Screening (\> or ≤100,000 copies/mL)).
| Arm | Type | Description |
|---|---|---|
| Test Arm | EXPERIMENTAL | Vicriviroc 30 mg QD |
| Placebo Control Arm | PLACEBO_COMPARATOR | Placebo |
| Vicriviroc + Reyataz + ritonavir | EXPERIMENTAL | vicriviroc 30 mg tablet QD + Reyataz® (atazanavir sulfate) 300 mg (1x300 mg capsule or 2x150 mg capsules) QD + Norvir® (ritonavir) 100 mg capsule QD |
| Truvada® + Reyataz + ritonavir | ACTIVE_COMPARATOR | Truvada® 200/300 combination tablet QD + Reyataz® (atazanavir sulfate) 300 mg (1x300 mg capsule or 2x150 mg capsules) QD + Norvir® (ritonavir) 100 mg capsule QD |
| 1 | EXPERIMENTAL | Vicriviroc 30 mg QD |
| 2 | PLACEBO_COMPARATOR | Placebo |
| Double-Blind - Vicriviroc 30 mg | EXPERIMENTAL | Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized antiretroviral therapy (ART) regimen containing a ritonavir-boosted protease inhibitor (PI/r) for 48 weeks. |
| Double-Blind - Vicriviroc 20 mg | EXPERIMENTAL | Vicriviroc 20 mg QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks. |
| Double-Blind - Placebo | PLACEBO_COMPARATOR | Placebo QD, PO, plus an open-label optimized ART regimen containing a PI/r for 48 weeks. |
| Open-label - Vicriviroc 30 mg | EXPERIMENTAL | Vicriviroc 30 mg once daily (QD), orally (PO), plus an open-label optimized ART regimen containing a ritonavir-boosted protease inhibitor (PI/r) for up to 45 months. |
| VCV + Failing HAART | EXPERIMENTAL | Vicriviroc plus failing highly-active antiretroviral therapy |
| Name | Type | Description |
|---|---|---|
| Vicriviroc | DRUG | One tablet of vicriviroc 30 mg once daily. |
| Placebo | DRUG | One tablet of placebo once daily. |
| emtricitabine and tenofovir disoproxil fumarate | DRUG | one 200/300 combination tablet QD |
| Vicriviroc 30 mg | DRUG | Three tablets of vicriviroc 10 mg once daily for 48 weeks (Double-blind Period) or for up to 45 months (Open Label Period). |
| Vicriviroc 20 mg | DRUG | Two tablets of vicriviroc 10 mg once daily for 48 weeks. |
| Background ART Regimen | DRUG | An open-label ritonavir-boosted optimized background ART regimen containing ≥3 drugs (including a protease inhibitor \[PI\]) selected for each individual study participant by the investigator. The optimized regimens most commonly include new nucleoside analogs (NRTIs) and a PI, usually "boosted" with concomitant ritonavir. |
Inclusion Criteria: * Subject must be infected with HIV-1 virus. * Subject must have documented plasma HIV-1 RNA \>1000 copies/mL within 60 days of Visit 1/Day 1 (randomization) and must be either * on a stable regimen of 3 or more antiretrovirals (ART) for at least 4 weeks prior to the screeni...