Vicriviroc in HIV-Treatment Experienced Subjects (Study P04889AM8)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00474370|
Recruitment Status : Completed
First Posted : May 16, 2007
Last Update Posted : August 30, 2022
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|Condition or disease||Intervention/treatment||Phase|
|HIV Infections Acquired Immunodeficiency Syndrome||Drug: Vicriviroc Drug: Placebo||Phase 3|
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study of vicriviroc maleate in HIV subjects infected with CCR5-tropic virus only and who have documented resistance to at least 2 of the 3 antiretroviral drug classes (NRTI, NNRTI or PI) or at least 6 months experience with at
least 2 of the following: one NRTI, one NNRTI, or two PIs (excluding low-dose ritonavir)and failed at least one standard triple-drug regimen. The study will compare the virologic benefit of adding vicriviroc to an optimized background regimen to a control group receiving placebo plus the new optimized background therapy. The optimized background regimen will be chosen by the investigator based on results of drug susceptibility tests performed at Screening, history of prior antiretroviral drug use by the patient, and drug toxicity. OBT must include a PI boosted by ritonavir (>=100 mg of ritonavir), and at least 2 active drugs (ie, to which HIV isolate is fully susceptible). Primary efficacy analysis will be conducted when all subjects have completed 48 weeks of treatment. An interim analysis will be performed when all subjects have completed 24 weeks of treatment. After completing Week 48 of the study, subjects will be offered open-label vicriviroc 30 mg QD, if appropriate, until the drug is commercially available or until the sponsor terminates the clinical development of vicriviroc. Additionally, subjects who discontinued early from the study prior to Week 48 may be eligible for the open-label segment of the study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Vicriviroc in Combination Treatment With an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E4)|
|Actual Study Start Date :||May 15, 2007|
|Actual Primary Completion Date :||August 24, 2009|
|Actual Study Completion Date :||October 26, 2010|
Experimental: Test Arm
Vicriviroc 30 mg QD
One tablet of vicriviroc 30 mg once daily.
Other Name: SCH 417690
Placebo Comparator: Placebo Control Arm
One tablet of placebo once daily.
- Proportion of subjects with undetectable plasma HIV-1 RNA (<50 copies/mL) [ Time Frame: 48 weeks ]
- Mean change from baseline in plasma HIV-1 RNA (log10 copies/mL); Proportion of subjects with <400 copies/mL of plasma HIV-1 RNA; Proportion of subjects with at least 2log10 reduction from baseline in plasma HIV-1 RNA [ Time Frame: 48 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||16 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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 screening visit
- on no ART agents for at least 4 weeks prior to
the screening visit.
- Subject must be ART experienced and have documented resistance to at least 2 of the following 3 drug classes: nucleoside reverse transcriptase inhibitor (NRTI); non-nucleoside reverse transcriptase inhibitor (NNRTI); or protease inhibitor (PI)
Subject must have ART class experience for at least 6 months with at least two of the following: one NRTI; one NNRTI; two PIs (excluding low-dose ritonavir).
- Women of child-bearing potential must agree to use a medically accepted method of contraceptive as defined by the protocol.
- Subject must be willing to initiate CD4+ cell count-guided chemoprophylaxis to prevent opportunistic infection as defined in protocol.
- Subjects with detectable CXCR4-tropic or dual/mixed CCR5/CXCR4-tropic HIV isolates at Screening.
- Subjects with prior history of malignancy (with exceptions of cutaneous Kaposi's sarcoma without visceral or mucosal involvement that resolved with HAART but without systemic anti-cancer treatment, and basal-cell carcinoma of skin); or prior receipt of cytotoxic cancer chemotherapy that may increase the risk of malignancy.
- Subjects with seizure disorder requiring anti-seizure therapy or with any condition that is likely to increase risk of seizure (CNS malignancy or toxoplasmosis).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474370
|Study Director:||Medical Director||Merck Sharp & Dohme LLC|
|Responsible Party:||Merck Sharp & Dohme LLC|
|Other Study ID Numbers:||
2006-006417-32 ( EudraCT Number )
|First Posted:||May 16, 2007 Key Record Dates|
|Last Update Posted:||August 30, 2022|
|Last Verified:||August 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
Acquired Immunodeficiency Syndrome
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immune System Diseases
Slow Virus Diseases