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

Study Overview
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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.

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.

Official Title
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COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Vicriviroc maleate
* Drug: Vicriviroc maleate
* Drug: Placebo
* Drug: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Unwillingness to participate in the registry or give informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previous vicriviroc 30 mg QD<br>Subjects who previously received vicriviroc 30 mg daily in a Phase 2 or 3 clinical trial. | Drug: Vicriviroc maleate<br>* Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.<br>* Other names: SCH 417690;|
| Previous vicriviroc 20 mg QD<br>Subjects who previously received vicriviroc 20 mg daily in a Phase 2 or 3 clinical trial. | Drug: Vicriviroc maleate<br>* Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.<br>* Other names: SCH 417690;|
| Control Group<br>Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc. | Drug: Placebo<br>* Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol.<br>Drug: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg<br>* 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.<br>* Other names: Truvada;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Experienced