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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

Primary Purpose

HIV Infections, HIV Lipodystrophy Syndrome

Status

Terminated

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

non-nucleoside reverse transcriptase inhibitors

nucleoside reverse transcriptase inhibitors

protease inhibitors

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV infections, HIV Lipodystrophy Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere

Outcomes

Primary Outcome Measures

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 Measures

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

Full Information

NCT ID

NCT00122655

First Posted

July 21, 2005

Last Updated

November 14, 2005

Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

1. Study Identification

Unique Protocol Identification Number

NCT00122655

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2005

Overall Recruitment Status

Terminated

Study Start Date

January 2001 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

French National Agency for Research on AIDS and Viral Hepatitis

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections, HIV Lipodystrophy Syndrome

Keywords

HIV infections, HIV Lipodystrophy Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

non-nucleoside reverse transcriptase inhibitors

Intervention Type

Drug

Intervention Name(s)

nucleoside reverse transcriptase inhibitors

Intervention Type

Drug

Intervention Name(s)

protease inhibitors

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

Title

Change in CD4 cell count between day 0 (D0) and week 48

Title

Change in lipid profile and glucidic metabolism between D0 and week 48

Title

Evolution of SAT/TAT and VAT/TAT between D0 and week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marc Antoine Valantin, MD

Organizational Affiliation

Service des Maladies Infectieuses Hopital Pitie-Salpetriere Paris

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dominique Costagliola

Organizational Affiliation

INSERM U720

Official's Role

Study Chair

Facility Information:

Facility Name

Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Learn more about this trial

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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