Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)
COVER
COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry
1 other identifier
observational
180
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2007
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 26, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFebruary 5, 2015
February 1, 2015
3.2 years
June 23, 2008
February 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 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.
Every 6 months.
Study Arms (3)
Previous vicriviroc 30 mg QD
Subjects who previously received vicriviroc 30 mg daily in a Phase 2 or 3 clinical trial.
Previous vicriviroc 20 mg QD
Subjects who previously received vicriviroc 20 mg daily in a Phase 2 or 3 clinical trial.
Control Group
Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc.
Interventions
Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.
Follow-up for subjects who previously received placebo tablet administered once daily according to the parent protocol.
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.
Eligibility Criteria
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.
You may qualify if:
- Subjects must have participated in a Phase 2 or 3 study involving vicriviroc, and must have received, but are no longer receiving study medication.
You may not qualify if:
- Unwillingness to participate in the registry or give informed consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 26, 2008
Study Start
July 1, 2007
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
February 5, 2015
Record last verified: 2015-02