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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00122655
• Other study ID #: ANRS108 NONUKE
• Status: Terminated
• Phase: Phase 4
• First received: July 21, 2005
• Last updated: November 14, 2005
• Start date: January 2001
• Est. completion date: June 2005

Study information

• Verified date: November 2005
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• HIV Lipodystrophy Syndrome
• HIV-Associated Lipodystrophy Syndrome
• Lipodystrophy

Intervention

Drug:
• non-nucleoside reverse transcriptase inhibitors

• nucleoside reverse transcriptase inhibitors

• protease inhibitors

Locations

Country	Name	City	State
France	Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Change in CD4 cell count between day 0 (D0) and week 48
Secondary	Change in lipid profile and glucidic metabolism between D0 and week 48
Secondary	Evolution of SAT/TAT and VAT/TAT between D0 and week 48