skip to content

Clinical Trials

MainTitle

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
Merck Sharp & Dohme Corp.


Information provided by (Responsible Party)
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier
NCT00705419

First received: June 23, 2008
Last updated: February 4, 2015
Last Verified: February 2015
History of Changes
Purpose

Purpose

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 Intervention
HIV Infections

Drug : Vicriviroc maleate
Drug : Placebo
Drug : Emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVER - Continuing Observation After Vicriviroc (VCV) Exposure Registry

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures

  • 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:
  • 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. ]

Enrollment: 180
Study Start Date: July 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705419

Sponsors and Collaborators

Merck Sharp & Dohme Corp.
More Information

More Information


Responsible Party: Merck Sharp & Dohme Corp.  
ClinicalTrials.gov Identifier: NCT00705419   History of Changes  
Other Study ID Numbers: P04999  
Study First Received: June 23, 2008  
Last Updated: February 4, 2015  

Keywords provided by Merck Sharp & Dohme Corp.:

Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Tenofovir
Emtricitabine
Maleic acid

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.