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

NCT00705419 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 180

Last updated 2015-02-05

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections

Interventions

DRUG

Vicriviroc maleate

Follow-up for subjects who previously received 30 mg tablet administered once daily according to the parent protocol.

DRUG

Vicriviroc maleate

Follow-up for subjects who previously received 20 mg tablet administered once daily according to the parent protocol.

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.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2010-09-30
Completion
2010-09-30

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00705419 on ClinicalTrials.gov