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Study of Reyataz in HIV-infected Patients With Lipodystrophy Syndrome

NCT00135356 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2010-05-07

Study results available
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Summary

The purpose of this clinical research study is to learn if human immunodeficiency virus (HIV)-infected subjects with abdominal fat accumulation on their highly active antiretroviral treatment (HAART) regimen have better changes in fat distribution after switching to atazanavir-ritonavir than those remaining on their current protease inhibitor boosted HAART regimen.

Conditions

  • HIV-Associated Lipodystrophy Syndrome

Interventions

DRUG

Atazanavir (ATV) + ritonavir (RTV), continuation of backbone 2 nucleoside reverse transcriptase inhibitor (NRTIs)

Capsules, Oral, ATV 300 mg + RTV 100 mg once daily up to 96 weeks

DRUG

continuation of current HAART (boosted protease inhibitor [PI] combination + 2 NRTIs)

Protease inhibitor \[PI\] combination + 2 NRTIs

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2007-07-31
Completion
2008-06-30

Countries

  • United States
  • Canada
  • France
  • Germany
  • Italy
  • Mexico
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT00135356 on ClinicalTrials.gov