Vicriviroc in HIV-Treatment Experienced Subjects (Study P04405AM3) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00523211

Purpose

Vicriviroc (vye-kri-VYE-rock) is an investigational drug (not yet approved by Government Regulatory Authorities for commercial use) that belongs to a new class of drugs, called CCR5 receptor blockers. This group of drugs blocks one of the ways HIV enters T-cells (the cells that fight infection). Previous smaller studies in HIV treatment-experienced patients, have shown that vicriviroc is safe and effective. The purpose of this study is to confirm the previous findings in a larger phase 3 study over a 48-week period, and show that when taken in combination with other appropriate HIV drugs, vicriviroc can decrease the level of HIV (viral load) in the blood and that it is well tolerated.

Condition	Intervention	Phase
HIV Infections Acquired Immunodeficiency Syndrome	Drug: Vicriviroc maleate 30 mg Drug: Placebo tablet	Phase III

MedlinePlus related topics: AIDS

Drug Information available for: Vicriviroc Vicriviroc maleate

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:

Vicriviroc in Combination Treatment With an Optimized ART Regimen in HIV-Infected Treatment-Experienced Subjects (VICTOR-E3)

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Proportion of subjects with undetectable plasma HIV-1 RNA (<50 copies/mL) [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 >=2log10 reduction from baseline in plasma HIV-1 RNA [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:

375

Study Start Date:

July 2007

Estimated Study Completion Date:

June 2009

Estimated Primary Completion Date:

June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Test Arm: Experimental Vicriviroc 30 mg QD	Drug: Vicriviroc maleate 30 mg One tablet of vicriviroc maleate 30 mg once daily for 48 weeks.
Placebo Control Arm: Placebo Comparator Placebo	Drug: Placebo tablet One tablet of placebo once daily for 48 weeks.

Detailed Description:

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, 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. If vicriviroc at the dose studied proves to be safe and efficacious, study participants who successfully complete 48 weeks of treatment or for whom vicriviroc is medically appropriate will be offered vicriviroc free of charge until the drug is commercially available.

Eligibility

Ages Eligible for Study:

16 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

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 antiretroviral (ART) for at least 4 weeks prior to the screening visit OR
- 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) OR 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.

Exclusion Criteria:

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 cytoxic 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00523211