Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E1) (Study P03672AM6)
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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). The purpose of this 48-week study is to evaluate 2 dose levels of vicriviroc in HIV patients who have not responded adequately to standard HIV treatments. This study was designed to evaluate these doses of vicriviroc, when taken in combination with other appropriate HIV drugs, in terms of ability to decrease the level of HIV (viral load) in the blood and safety
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Vicriviroc maleate 20 mg Drug: Vicriviroc maleate 30 mg Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E1) |
- Log10 change from baseline in HIV RNA [ Time Frame: 48 weeks of treatment ] [ Designated as safety issue: No ]
- Proportion of subjects with >=1.0 log10 change from baseline in HIV RNA; Proportion of subjects with HIV RNA <400 copies/mL; Time to virologic failure [ Time Frame: 48 weeks of treatment ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | September 2005 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vicriviroc 20 mg |
Drug: Vicriviroc maleate 20 mg
Two tablets of vicriviroc maleate 10 mg and one tablet of placebo once daily for 48 weeks. Then, for subjects who meet applicable criteria, one tablet of vicriviroc maleate 30 mg once daily, if appropriate, until the sponsor terminates the clinical development of vicriviroc.
Other Name: SCH 417690
|
| Experimental: Vicriviroc 30 mg |
Drug: Vicriviroc maleate 30 mg
Three tablets of vicriviroc maleate 10 mg once daily for 48 weeks. Then, for subjects who meet applicable criteria, one tablet of vicriviroc maleate 30 mg once daily, if appropriate, until the sponsor terminates the clinical development of vicriviroc.
Other Name: SCH 417690
|
| Placebo Comparator: Placebo |
Drug: Placebo
Three tablets of placebo once daily for 48 weeks. Then, for subjects who meet applicable criteria, one tablet of vicriviroc maleate 30 mg once daily, if appropriate, until the sponsor terminates the clinical development of vicriviroc
|
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 for whom standard antiretroviral treatment (ART) has failed. The study will evaluate the antiviral efficacy of two doses of vicriviroc (20 mg QD and 30 mg QD) compared with placebo when added to optimized ART therapy. The optimized background regimen will be chosen by the investigator based on results of drug susceptibility tests, history of prior antiretroviral drug use by the subject, and drug toxicity. The background regimen must include at least 3 antiretroviral drugs (not including study drug), one of which must be a ritonavir boosted protease inhibitor (≥100 mg ritonavir). There will be two interim analyses: when all subjects have completed 12 weeks and 24 weeks of treatment, respectively. Based on the balance of safety and efficacy determined in these analyses, a dosage or dosages will be selected for further study in additional registrational trials. The primary efficacy analysis will be conducted when all subjects have completed 48 weeks of treatment. After Week 48, subjects who meet applicable criteria will be offered open label vicriviroc 30 mg QD, if appropriate, until the sponsor terminates the clinical development of vicriviroc. Additionally, subjects who discontinue early from the study prior to Week 48 will be offered re-screening for the open label segment of the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult subjects with documented HIV infection with no detectable CXCR4
- Prior therapy for >=3 months with >=3 classes of currently marketed (US FDA-approved) antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening
- HIV 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 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 CNS condition or drug use predisposing to seizure in the opinion of the investigator
- No active AIDS-defining opportunistic infection
Contacts and Locations More Information
No publications provided by Schering-Plough
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00243230 History of Changes |
| Other Study ID Numbers: | P03672, EudraCT number 2005-001057-21 |
| Study First Received: | October 20, 2005 |
| Last Updated: | April 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Maleic acid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013