The aim of this trial is to evaluate the impact on fat distribution of a switching to NRTI-sparing regimens in lipoatrophic antiretroviral experienced patients with complete viral suppression. Maintenance of virological suppression and immunological factors are also assessed.

Condition	Intervention	Phase
HIV Infections HIV Lipodystrophy Syndrome	Drug: non-nucleoside reverse transcriptase inhibitors  Drug: nucleoside reverse transcriptase inhibitors  Drug: protease inhibitors	Phase IV

Further Study Details: 

Primary Outcomes: Evolution from inclusion to week 48 of the peripheral fat tissue measured on CT scan by a volumetric fat centralized evaluation of the thighs.
Secondary Outcomes: Evolution of the viral load from inclusion to week 48 and proportion of patients with a VL over 400 copies/ml at week 48; Change in CD4 cells count between D0 and week 48; Change in lipid profile and glucidic metabolism between D0 and week 48; Evolution of SAT/TAT and VAT/TAT between D0 and week 48
Expected Total Enrollment:  100

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-associated toxicities. The current standard-of-care HAART regimens include a backbone of 2 nucleoside reverse transcriptase inhibitors (NRTIs). Many studies have demonstrated that NRTIs particularly thymidine analogue nucleosides are important contributors to the development of lipoatrophy. This antiretroviral family inhibits also the mitochondrial gamma-DNA polymerase, which leads to mitochondrial dysfunction and side effects such as peripheral neuropathy, pancreatitis and liver dysfunction

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria: - Males and non-pregnant females - With confirmed laboratory diagnosis of HIV infection - Patients receiving a 2 or 3 NRTI-containing antiretroviral treatment since 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 Criteria: - Current antiretroviral therapy with 3 class of antiretroviral therapy - Previous virologic failure with NNRTI or PI - Intolerance to nevirapine and efavirenz - Acute opportunistic infection - Diabetes - Transaminase levels over 5 times above the upper normal limit - HBV co-infection if the patient is receiving lamivudine therapy - Ongoing immunotherapy including IL-2 and interferon - Pregnancy or project of pregnancy

France
      Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere, Paris,  75013,  France

Study chairs or principal investigators

Marc Antoine Valantin, MD,  Principal Investigator,  Service des Maladies Infectieuses Hopital Pitie-Salpetriere Paris   
Dominique Costagliola,  Study Chair,  INSERM U720   

Study ID Numbers:  ANRS108 NONUKE
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122655
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-07-26