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

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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