Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy

Phase 4

Terminated

• Conditions: HIV Infections; HIV Lipodystrophy Syndrome

• Registration Number: NCT00122655
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

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.

Maintenance of virological suppression and immunological factors are also assessed.

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-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.

Study Timeline

• Study Start: 2001-01
• Study Completion: 2005-06
• Study First Submitted: 2005-07-21
• Study First Submitted QC: 2005-07-21
• Study First Posted: 2005-07-22
• Status Verified: 2005-11
• Last Update Submitted: 2005-11-14
• Last Update Posted: 2005-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evolution from inclusion to week 48 of the peripheral fat tissue measured on computed tomography (CT) scan by a volumetric fat centralized evaluation of the thighs

Secondary Outcome Measures

Name	Time	Method
Evolution of the viral load (VL) from inclusion to week 48 and proportion of patients with a VL over 400 copies/ml at week 48
Change in CD4 cell count between day 0 (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

Trial Locations

Locations (1)

Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere; 🇫🇷 Paris, France