Status:
TERMINATED
Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infections
HIV Lipodystrophy Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of this trial is to evaluate the impact on fat distribution of switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression. Maintena...
Detailed Description
Limitations on achieving complete HIV eradication render it necessary to maintain highly active antiretroviral treatment over long periods, which may lead to the development of antiretroviral-associat...
Eligibility Criteria
Inclusion
- Males and non-pregnant females
- Confirmed laboratory diagnosis of HIV infection
- Patients receiving a 2 or 3 NRTI-containing antiretroviral treatment for at least 3 months
- Viral load below 400 copies/ml
- Patients with a clinical peripheral lipoatrophy isolated or associated with a lipohypertrophy self reported by the patient and confirmed by physical examination
Exclusion
- Current antiretroviral therapy with 3 classes of antiretroviral therapy
- Previous virologic failure with a non-nucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI)
- Intolerance to nevirapine and efavirenz
- Acute opportunistic infection
- Diabetes
- Transaminase levels over 5 times above the upper normal limit
- Hepatitis B virus (HBV) co-infection if the patient is receiving lamivudine therapy
- Ongoing immunotherapy including interleukin-2 (IL-2) and interferon
- Pregnancy or planned pregnancy
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00122655
Start Date
January 1 2001
End Date
June 1 2005
Last Update
November 15 2005
Active Locations (1)
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1
Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere
Paris, France, 75013