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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Terminated

Phase 4

Conditions

HIV Lipodystrophy Syndrome

HIV Infections

Treatments

Drug: protease inhibitors

Drug: nucleoside reverse transcriptase inhibitors

Drug: non-nucleoside reverse transcriptase inhibitors

Study type

Interventional

Funder types

Other

Identifiers

NCT00122655

ANRS108 NONUKE

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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