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 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

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04999
Study First Received:	June 23, 2008
Last Updated:	April 3, 2009
ClinicalTrials.gov Identifier:	NCT00705419 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Schering-Plough:

Treatment Experienced

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases

Emtricitabine
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Tenofovir
Retroviridae Infections
Tenofovir disoproxil

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Emtricitabine
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil

RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on May 06, 2009