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

COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00705419

Acronym

COVER

Enrollment

180

Registered

2008-06-26

Start date

2007-07-31

Completion date

2010-09-30

Last updated

2015-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Treatment Experienced

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.

Interventions

DRUGVicriviroc maleate

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

DRUGPlacebo

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

DRUGEmtricitabine 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	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

Measure	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026