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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

NCT ID: NCT00122655

Last Updated: 2005-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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HIV Infections HIV Lipodystrophy Syndrome

Keywords

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HIV infections HIV Lipodystrophy Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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non-nucleoside reverse transcriptase inhibitors

Intervention Type DRUG

nucleoside reverse transcriptase inhibitors

Intervention Type DRUG

protease inhibitors

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Marc Antoine Valantin, MD

Role: PRINCIPAL_INVESTIGATOR

Service des Maladies Infectieuses Hopital Pitie-Salpetriere Paris

Dominique Costagliola

Role: STUDY_CHAIR

INSERM U720

Locations

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Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ANRS108 NONUKE

Identifier Type: -

Identifier Source: org_study_id