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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Previous vicriviroc 30 mg QD

Subjects who previously received vicriviroc 30 mg daily in a Phase 2 or 3 clinical trial.

Vicriviroc maleate

Intervention Type DRUG

Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.

Previous vicriviroc 20 mg QD

Subjects who previously received vicriviroc 20 mg daily in a Phase 2 or 3 clinical trial.

Vicriviroc maleate

Intervention Type DRUG

Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.

Control Group

Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc.

Placebo

Intervention Type DRUG

Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol.

Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg

Intervention Type DRUG

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.

Interventions

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Vicriviroc maleate

Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.

Intervention Type DRUG

Vicriviroc maleate

Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.

Intervention Type DRUG

Placebo

Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol.

Intervention Type 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.

Intervention Type DRUG