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

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ClinicalTrials.gov Identifier: NCT00705419
Recruitment Status : Completed
First Posted : June 26, 2008
Last Update Posted : February 5, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
HIV Infections Drug: Vicriviroc maleate Drug: Placebo Drug: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg

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.

Study Design

Study Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry
Study Start Date : July 2007
Primary Completion Date : September 2010
Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Previous vicriviroc 30 mg QD
Subjects who previously received vicriviroc 30 mg daily in a Phase 2 or 3 clinical trial.
Drug: Vicriviroc maleate
Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.
Other Name: SCH 417690
Previous vicriviroc 20 mg QD
Subjects who previously received vicriviroc 20 mg daily in a Phase 2 or 3 clinical trial.
Drug: Vicriviroc maleate
Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.
Other Name: SCH 417690
Control Group
Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc.
Drug: Placebo
Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol.
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.
Other Name: Truvada


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The registry will enroll subjects who received vicriviroc or control in a Phase 2 or 3 clinical trial (with the exception of P03802 and ACTG A5211 [and its rollover P04100]), and are no longer receiving study medication.
Criteria

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.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705419     History of Changes
Other Study ID Numbers: P04999
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Tenofovir
Emtricitabine
Maleic acid
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents