Brief Title
Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy
Official Title
A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study
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 Phase
Phase 4
Study Type
Interventional
Primary Outcome
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
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
Condition
HIV Infections
Intervention
non-nucleoside reverse transcriptase inhibitors
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
January 2001
Completion Date
June 2005
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Marc Antoine Valantin, MD, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT00122655
Organization ID
ANRS108 NONUKE
Study Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
Study Sponsor
Marc Antoine Valantin, MD, Principal Investigator, Service des Maladies Infectieuses Hopital Pitie-Salpetriere Paris
Verification Date
November 2005