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Completed

NCT Number: NCT00705419

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

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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Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vicriviroc maleate

Drug

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

Other names: SCH 417690

Placebo

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

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.

Other names: Truvada

Primary outcomes

  1. Incidence of malignancies, AIDS-defining events, other clinical events of importance, and death.

    Time frame: Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.

Secondary outcomes

  1. Incidence of change in plasma viral tropism, time to change in plasma viral tropism, and change in HIV RNA and CD4+ counts, if available.

    Time frame: Every 6 months.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry

Acronym: COVER

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jun 26, 2008
Registry last updated
Feb 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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