NCT00122655

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

A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: French National Agency for Research on AIDS and Viral Hepatitis · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HIV Infections
• HIV Lipodystrophy Syndrome

Interventions

Type	Name	Description
DRUG	non-nucleoside reverse transcriptase inhibitors
DRUG	nucleoside reverse transcriptase inhibitors
DRUG	protease inhibitors

Timeline

• Start date: 2001-01-01
• Completion: 2005-06-01
• First posted: 2005-07-22
• Last updated: 2005-11-15

Locations

1 site across 1 country: France