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

This study has been terminated.
Sponsor:
Information provided by:
French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:
NCT00122655
First received: July 21, 2005
Last updated: November 14, 2005
Last verified: November 2005

July 21, 2005
November 14, 2005
January 2001
Not Provided
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
Evolution from inclusion to week 48 of the peripheral fat tissue measured on CT scan by a volumetric fat centralized evaluation of the thighs.
Complete list of historical versions of study NCT00122655 on ClinicalTrials.gov Archive Site
  • 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
  • Evolution of the viral load from inclusion to week 48 and proportion of patients with a VL over 400 copies/ml at week 48
  • Change in CD4 cells count between 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
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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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • HIV Lipodystrophy Syndrome
  • Drug: non-nucleoside reverse transcriptase inhibitors
  • Drug: nucleoside reverse transcriptase inhibitors
  • Drug: protease inhibitors
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
100
June 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00122655
ANRS108 NONUKE
Not Provided
Not Provided
French National Agency for Research on AIDS and Viral Hepatitis
Not Provided
Principal Investigator: Marc Antoine Valantin, MD Service des Maladies Infectieuses Hopital Pitie-Salpetriere Paris
Study Chair: Dominique Costagliola INSERM U720
French National Agency for Research on AIDS and Viral Hepatitis
November 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP