Status:
TERMINATED
Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infections
HIV-Associated Lipodystrophy Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 antiretrovir...
Detailed Description
The study compare the rate of occurrence of lipoatrophy in ARVnaive HIV-1 infected patients receiving either a NRTI-sparing antiretroviral therapy with NRTI and boosted PI,or a standard antiretroviral...
Eligibility Criteria
Inclusion
- Confirmed HIV-1-infected diagnosis
- Naive of antiretroviral treatment
- Plasma viral load (VL) over 5000 copies/ ml
- CD4 count below or equal to 350/mm3 or CD4 over 350/mm3 and VL over or equal to 100 000 copies/ml
- Written, informed consent after approval by the local human research ethics committee
Exclusion
- Acute opportunistic infection
- Pregnancy or breast feeding
- Cytotoxic systemic chemotherapy except for Kaposi sarcoma
- Patient infected with B or C hepatitis requiring specific treatment at the beginning of the study
- Polynuclear neutrophils below 750/mm3
- Hemoglobin below 8 g/dl
- Platelets below 20 000/mm3
- Creatinine level over 1.5 (upper normal) UN
- ASAT, ALAT, bilirubin level over 3 UN
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00122668
Start Date
November 1 2003
End Date
July 1 2005
Last Update
November 15 2005
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere
Paris, France, 75013