Registry to Assess Long-term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999)(COMPLETED) (COVER)
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00705419
First received: June 23, 2008
Last updated: February 6, 2013
Last verified: February 2013
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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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
MedlinePlus related topics:
HIV/AIDS
Drug Information available for:
Formic acid
Emtricitabine
Tenofovir
Tenofovir Disoproxil Fumarate
Truvada
U.S. FDA Resources
Further study details as provided by Merck:
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. ] [ Designated as safety issue: Yes ]
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. ] [ Designated as safety issue: No ]
| 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) |
| Groups/Cohorts | 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Vice President of Late Stage Development, 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 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Merck:
|
Treatment Experienced |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Maleic acid Tenofovir |
Tenofovir disoproxil Emtricitabine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 17, 2013