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

Phase 4TerminatedNCT00122655

French National Agency for Research on AIDS and Viral Hepatitis100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

HIV Infections HIV Lipodystrophy Syndrome

Interventions

non-nucleoside reverse transcriptase inhibitorsDRUG

nucleoside reverse transcriptase inhibitorsDRUG

protease inhibitorsDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere

Paris, France

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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