Status:
WITHDRAWN
Vicriviroc, a CCR5 Inhibitor, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV (VICTOR-E2) (Study P04285
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
HIV Infections
Acquired Immunodeficiency Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an international study of vicriviroc in 500 adult HIV-infected subjects who are failing standard antiretroviral therapy (ART). HIV must be of a certain type known as R5/X4-mixed tropic. Subjec...
Detailed Description
This is a randomized, placebo-controlled, multi-site, parallel-group, double-blind study of vicriviroc (SCH 417690) in 500 adult HIV-infected subjects with R5/X4 mixed viral tropism who have at least ...
Eligibility Criteria
Inclusion
- Adult subjects with documented R5/X4 mixed-tropic HIV infection
- Prior therapy for greater than or equal to 3 months with greater than or equal to 3 classes of currently marketed antiretroviral agents (NRTIs, NNRTIs, PIs, or fusion inhibitors) at any time prior to screening
- HIV RNA greater than or equal to 5000 copies/mL on a stable ART regimen of at least 3 months of duration
- Greater than or equal to 1 genotypically documented resistance mutation to a reverse transcriptase (RT) inhibitor and greater than or equal to 1 primary resistance mutation to a PI
- Acceptable hematologic, renal, and hepatic laboratory parameters.
Exclusion
- No history of recurrent seizure or CNS condition predisposing to seizure
- No active AIDS-defining opportunistic infection
- Subjects who have previously used a CCR5 inhibitor for greater than 4 weeks and/or within 30 days of the screening visit
- Use of any drugs that predispose to seizures.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00243568
Start Date
September 1 2005
Last Update
September 12 2019
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