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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705419
First received: June 23, 2008
Last updated: February 28, 2014
Last verified: February 2014

June 23, 2008
February 28, 2014
July 2007
September 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00705419 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

HIV Infections
  • 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
  • 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
  • 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
  • Previous vicriviroc 30 mg QD
    Subjects who previously received vicriviroc 30 mg daily in a Phase 2 or 3 clinical trial.
    Intervention: Drug: Vicriviroc maleate
  • Previous vicriviroc 20 mg QD
    Subjects who previously received vicriviroc 20 mg daily in a Phase 2 or 3 clinical trial.
    Intervention: Drug: Vicriviroc maleate
  • Control Group
    Subjects who previously received active control or placebo in a Phase 2 or 3 clinical trial involving vicriviroc.
    Interventions:
    • Drug: Placebo
    • Drug: Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
September 2010
September 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00705419
P04999
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP