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

Sponsored by:	French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00122668

Purpose

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).

Condition	Intervention	Phase
HIV Infections HIV-Associated Lipodystrophy Syndrome	Drug: non-nucleoside reverse transcriptase inhibitors Drug: nucleoside reverse transcriptase inhibitors Drug: protease inhibitor	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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)

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

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)

Estimated Enrollment:	112
Study Start Date:	November 2003
Estimated Study Completion Date:	July 2005

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122668

Locations

France
Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere
Paris, France, 75013

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Principal Investigator:	Claudine Duvivier, MD	Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, Paris
Study Chair:	Dominique Costagliola	INSERM U 720

More Information

No publications provided by French National Agency for Research on AIDS and Viral Hepatitis

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Soulié 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.

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;27(7):817-24.

Duvivier C, Ghosn J, Assoumou L, Soulié C, Peytavin G, Calvez V, Génin 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. Epub 2008 Jul 18.

Study ID Numbers:	ANRS121 HIPPOCAMPE
Study First Received:	July 21, 2005
Last Updated:	November 14, 2005
ClinicalTrials.gov Identifier:	NCT00122668 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

HIV Protease Inhibitors
HIV-Associated Lipodystrophy Syndrome
HIV infections

Study placed in the following topic categories:

Anti-Infective Agents
HIV Protease Inhibitors
Sexually Transmitted Diseases, Viral
Metabolic Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Antiviral Agents
Immunologic Deficiency Syndromes
Protease Inhibitors
Reverse Transcriptase Inhibitors

Virus Diseases
HIV-Associated Lipodystrophy Syndrome
Anti-Retroviral Agents
HIV Infections
Lipodystrophy
Sexually Transmitted Diseases
Retroviridae Infections
Metabolic Disorder
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Reverse Transcriptase Inhibitors
Pathologic Processes
Anti-Retroviral Agents
Therapeutic Uses
Syndrome
Lipodystrophy
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors
RNA Virus Infections
Metabolic Diseases

Disease
Immune System Diseases
Skin Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Protease Inhibitors
Virus Diseases
HIV-Associated Lipodystrophy Syndrome
HIV Infections
Skin Diseases, Metabolic
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on August 28, 2009