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

Primary Purpose

HIV Infections, HIV-Associated Lipodystrophy Syndrome

Status

Terminated

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

non-nucleoside reverse transcriptase inhibitors

nucleoside reverse transcriptase inhibitors

protease inhibitor

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere

Outcomes

Primary Outcome Measures

Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96

Secondary Outcome Measures

During the study until 96 weeks

Viro-immunologic efficacy: Proportion of patients with a plasma viral load below 400 and 50 copies/ml

Evolution of viral load

Evolution of CD4 lymphocytes

Evaluation of clinical safety

Evaluation of lipohypertrophic syndrome

Evaluation of glucidic and lipids metabolic profile

Evaluation of mitochondrial toxicity

Evaluation of bone toxicity by measurement of bone density

Evaluation of plasma trough concentration of protease inhibitors and non nucleoside reverse transcriptase inhibitors

Evaluation of intracellular concentration of nucleoside reverse transcriptase inhibitors

Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF)

Full Information

NCT ID

NCT00122668

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

NCT00122668

Brief Title

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

Official Title

Randomized Comparative Study Evaluating the Rate of Occurrence of a Lipoatrophy Syndrome in ARVnaive HIV-1 Infected Patients Receiving NRTI-Sparing Antiretroviral Regimen (Hippocampe - ANRS 121)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2005

Overall Recruitment Status

Terminated

Study Start Date

November 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 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 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

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.

6. Conditions and Keywords

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

HIV Infections, HIV-Associated Lipodystrophy Syndrome

Keywords

HIV Protease Inhibitors, HIV-Associated Lipodystrophy Syndrome, HIV infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

112 (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 inhibitor

Primary Outcome Measure Information:

Title

Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96

Secondary Outcome Measure Information:

Title

During the study until 96 weeks

Title

Viro-immunologic efficacy: Proportion of patients with a plasma viral load below 400 and 50 copies/ml

Title

Evolution of viral load

Title

Evolution of CD4 lymphocytes

Title

Evaluation of clinical safety

Title

Evaluation of lipohypertrophic syndrome

Title

Evaluation of glucidic and lipids metabolic profile

Title

Evaluation of mitochondrial toxicity

Title

Evaluation of bone toxicity by measurement of bone density

Title

Evaluation of plasma trough concentration of protease inhibitors and non nucleoside reverse transcriptase inhibitors

Title

Evaluation of intracellular concentration of nucleoside reverse transcriptase inhibitors

Title

Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF)

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

Claudine Duvivier, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dominique Costagliola

Organizational Affiliation

INSERM U 720

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

Citations:

PubMed Identifier

19487903

Citation

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.

Results Reference

derived

PubMed Identifier

19363330

Citation

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.

Results Reference

derived

PubMed Identifier

18641035

Citation

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.

Results Reference

derived

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

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