Registry to Assess Long-Term Outcome in HIV Subjects Who Participated in Phase 2 and 3 Clinical Trials Involving Vicriviroc (Study P04999) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00705419

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

MedlinePlus related topics: AIDS

Drug Information available for: Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate Truvada Vicriviroc Vicriviroc maleate

U.S. FDA Resources

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

Further study details as provided by Schering-Plough:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	642
Study Start Date:	June 2007
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2015 (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.
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.
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.

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

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04999
Study First Received:	June 23, 2008
Last Updated:	December 14, 2008
ClinicalTrials.gov Identifier:	NCT00705419
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Treatment Experienced

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Emtricitabine
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Tenofovir
Retroviridae Infections
Immunologic Deficiency Syndromes
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009