Vicriviroc (SCH 417690) in Combination Treatment With Optimized ART Regimen in Experienced Subjects (VICTOR-E1) (Study P03672AM6) - Full Text View

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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Log10 change from baseline in HIV RNA [ Time Frame: 48 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Suleiman J, Zingman BS, Diaz RS, Madruga JV, DeJesus E, Slim J, Mak C, Lee E, McCarthy MC, Dunkle LM, Walmsley S. Vicriviroc in combination therapy with an optimized regimen for treatment-experienced subjects: 48-week results of the VICTOR-E1 phase 2 trial. J Infect Dis. 2010 Feb 15;201(4):590-9. doi: 10.1086/650342.


Responsible Party:	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:	September 24, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral	Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Maleic acid Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016