Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)

Completed

• Conditions: HIV Infections
• Interventions: Drug: Vicriviroc maleate; Drug: Placebo; Drug: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg

• Registration Number: NCT00705419
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

A non-probability sampling method will be used. Subjects will be requested to enroll in the registry after having completed or discontinued participation in a Phase 2 or 3 study involving vicriviroc.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-04
• Last Update Posted: 2015-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Subjects must have participated in a Phase 2 or 3 study involving vicriviroc, and must have received, but are no longer receiving study medication.

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Exclusion Criteria

• Unwillingness to participate in the registry or give informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg	Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc.
Previous vicriviroc 20 mg QD	Vicriviroc maleate	Subjects who previously received vicriviroc 20 mg daily in a Phase 2 or 3 clinical trial.
Previous vicriviroc 30 mg QD	Vicriviroc maleate	Subjects who previously received vicriviroc 30 mg daily in a Phase 2 or 3 clinical trial.
Control Group	Placebo	Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc.

Primary Outcome Measures

Name	Time	Method
Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death.	Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.

Secondary Outcome Measures

Name	Time	Method
Incidence of change in plasma viral tropism, time to change in plasma viral tropism, and change in HIV RNA and CD4+ counts, if available.	Every 6 months.