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

NCT00122668 | Terminated Phase 4

• 1 other identifier: ANRS121 HIPPOCAMPE
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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).

Conditions

HIV Infections; HIV-Associated Lipodystrophy Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

• 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

Interventions

non-nucleoside reverse transcriptase inhibitors DRUG

nucleoside reverse transcriptase inhibitors DRUG

protease inhibitor DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere

Paris, 75013, France

Location

Related Publications (3)

• 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.

  PMID: 19487903 DERIVED

• 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.

  PMID: 19363330 DERIVED

• 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.

  PMID: 18641035 DERIVED

MeSH Terms

Conditions

HIV Infections; HIV-Associated Lipodystrophy Syndrome

Interventions

Protease Inhibitors

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Lipodystrophy; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Claudine Duvivier, MD

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

  PRINCIPAL INVESTIGATOR

• Dominique Costagliola

  INSERM U 720

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 21, 2005
• First Posted: July 22, 2005
• Study Start: November 1, 2003
• Study Completion: July 1, 2005
• Last Updated: November 15, 2005

Record last verified: 2005-11

Locations

FR (1)