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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: HIV Infections

Treatments: Drug: Vicriviroc maleate; Drug: Placebo; Drug: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg

Study type: Observational

Funder types: Industry

Identifiers

NCT00705419

P04999

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

180 participants in 3 patient groups

Previous vicriviroc 30 mg QD

Description:

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

Treatment:

Drug: Vicriviroc maleate

Drug: Vicriviroc maleate

Previous vicriviroc 20 mg QD

Description:

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

Treatment:

Drug: Vicriviroc maleate

Drug: Vicriviroc maleate

Control Group

Description:

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

Treatment:

Drug: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg

Drug: Placebo