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Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients

NCT00122668 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2005-11-15

No results posted yet for this study

Summary

The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).

Conditions

  • HIV Infections
  • HIV-Associated Lipodystrophy Syndrome

Interventions

DRUG

non-nucleoside reverse transcriptase inhibitors

DRUG

nucleoside reverse transcriptase inhibitors

DRUG

protease inhibitor

Sponsors & Collaborators

  • French National Agency for Research on AIDS and Viral Hepatitis

    lead OTHER_GOV

Principal Investigators

  • Claudine Duvivier, MD · Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, Paris

  • Dominique Costagliola · INSERM U 720

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Completion
2005-07-31

Countries

  • France

Study Locations

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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 NCT00122668 on ClinicalTrials.gov