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Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients

NCT ID: NCT00122668

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

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2005-07-31

Brief Summary

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The aim of this randomized study is to compare the occurrence of lipoatrophy in HIV-1 infected, naive patients receiving either a nucleoside reverse transcriptase inhibitor (NRTI)-sparing antiretroviral therapy with non-nucleoside reverse transcriptase inhibitor (NNRTI) and boosted protease inhibitor (PI), or a standard antiretroviral therapy with 2 NRTI plus either PI or NNRTI. Lipoatrophy is evaluated by measurement of fat volume by computed tomography (CT)-scan and DEXA (Dual Energy X-ray Absorptiometry).

Detailed Description

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The study compare the rate of occurrence of lipoatrophy in ARVnaive HIV-1 infected patients receiving either a NRTI-sparing antiretroviral therapy with NRTI and boosted PI,or a standard antiretroviral therapy with 2 NRTI plus PI or NNRTI.

Patients were randomized (2:1:1) to either PI+NNRTI (Gp1) or standard therapy, 2NRTI+ either PI (Gp2) or + NNRTI (Gp3). The study-treatment were lopinavir/r 100/400mg bid or indinavir/r 100/400mg bid for PI-class, for NNRTI-class, efavirenz or nevirapine and all NRTIs except D4T and DDC at usual dosage.

Lipoatrophy is evaluated by evolution of subcutaneous fat in the limbs measured by DEXA (Dual Energy X-ray Absorptiometry)and CT-scan of the thighs between baseline and W96.

Conditions

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HIV Infections HIV-Associated Lipodystrophy Syndrome

Keywords

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HIV Protease Inhibitors HIV-Associated Lipodystrophy Syndrome HIV infections

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 inhibitor

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Confirmed HIV-1-infected diagnosis
* Naive of antiretroviral treatment
* Plasma viral load (VL) over 5000 copies/ ml
* CD4 count below or equal to 350/mm3 or CD4 over 350/mm3 and VL over or equal to 100 000 copies/ml
* Written, informed consent after approval by the local human research ethics committee

Exclusion Criteria

* Acute opportunistic infection
* Pregnancy or breast feeding
* Cytotoxic systemic chemotherapy except for Kaposi sarcoma
* Patient infected with B or C hepatitis requiring specific treatment at the beginning of the study
* Polynuclear neutrophils below 750/mm3
* Hemoglobin below 8 g/dl
* Platelets below 20 000/mm3
* Creatinine level over 1.5 (upper normal) UN
* ASAT, ALAT, bilirubin level over 3 UN
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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Claudine Duvivier, MD

Role: PRINCIPAL_INVESTIGATOR

Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, Paris

Dominique Costagliola

Role: STUDY_CHAIR

INSERM U 720

Locations

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Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere

Paris, , France

Site Status

Countries

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France

References

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Soulie C, Assoumou L, Ghosn J, Duvivier C, Peytavin G, Ait-Arkoub Z, Molina JM, Costagliola D, Katlama C, Calvez V, Marcelin AG. Nucleoside reverse transcriptase inhibitor-sparing regimen (nonnucleoside reverse transcriptase inhibitor + protease inhibitor) was more likely associated with resistance comparing to nonnucleoside reverse transcriptase inhibitor or protease inhibitor + nucleoside reverse transcriptase inhibitor in the randomized ANRS 121 trial. AIDS. 2009 Jul 31;23(12):1605-8. doi: 10.1097/QAD.0b013e32832d9031.

Reference Type DERIVED
PMID: 19487903 (View on PubMed)

Duvivier C, Kolta S, Assoumou L, Ghosn J, Rozenberg S, Murphy RL, Katlama C, Costagliola D; ANRS 121 Hippocampe study group. Greater decrease in bone mineral density with protease inhibitor regimens compared with nonnucleoside reverse transcriptase inhibitor regimens in HIV-1 infected naive patients. AIDS. 2009 Apr 27;23(7):817-24. doi: 10.1097/QAD.0b013e328328f789.

Reference Type DERIVED
PMID: 19363330 (View on PubMed)

Duvivier C, Ghosn J, Assoumou L, Soulie C, Peytavin G, Calvez V, Genin MA, Molina JM, Bouchaud O, Katlama C, Costagliola D; ANRS 121 study group. Initial therapy with nucleoside reverse transcriptase inhibitor-containing regimens is more effective than with regimens that spare them with no difference in short-term fat distribution: Hippocampe-ANRS 121 Trial. J Antimicrob Chemother. 2008 Oct;62(4):797-808. doi: 10.1093/jac/dkn278. Epub 2008 Jul 18.

Reference Type DERIVED
PMID: 18641035 (View on PubMed)

Other Identifiers

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ANRS121 HIPPOCAMPE

Identifier Type: -

Identifier Source: org_study_id