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

February 4, 2015 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

180

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • SCH 417690
Drug: Vicriviroc maleate
Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.
Other Names:
  • 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 30 mg tablet administered once daily according to the parent protocol.
Other Names:
  • SCH 417690
Drug: Vicriviroc maleate
Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.
Other Names:
  • 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 Names:
  • Truvada

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Information regarding clinical outcome will be collected every 6 months. Deaths will be collected on an ongoing basis.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Every 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (Estimate)

June 26, 2008

Study Record Updates

Last Update Posted (Estimate)

February 5, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04999

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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