Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)
NCT00705419 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 180
Last updated 2015-02-05
Summary
Nonrandomized, prospective, observational, multi-site registry to assess long-term safety, clinical outcome, deaths, and evolution of viral tropism in HIV subjects who completed or discontinued participation in Phase 2 or 3 clinical trials involving vicriviroc. Subjects will be followed for up to 5 years.
Conditions
- HIV Infections
Interventions
- DRUG
-
Vicriviroc maleate
Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.
- DRUG
-
Vicriviroc maleate
Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.
- DRUG
-
Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol.
- DRUG
-
Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg
Follow-up for subjects who previously received active control consisting of emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg combination tablet administered once daily according to the parent protocol.
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-07-31
- Primary Completion
- 2010-09-30
- Completion
- 2010-09-30
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