Sponsor study identifier
interventional
112
1 country
1
Study Start
November 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2003
Date type not reportedThis date has not been verified as actual or estimated.
July 2005
Date type not reportedThis date has not been verified as actual or estimated.
July 21, 2005
Actual (reported)July 22, 2005
Actual (reported)Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96
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
Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere
Paris, 75013, France
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.
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.
Claudine Duvivier, MD
Service des Maladies infectieuses et Tropicales, Hopital Pitie Salpetriere, Paris
Dominique Costagliola
INSERM U 720
First Submitted
July 21, 2005
First Posted
July 22, 2005
Study Start
November 2003
Date type not reportedThis date has not been verified as actual or estimated.
Study Completion
July 2005
Date type not reportedRegistry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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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.
This date has not been verified as actual or estimated.
Last Updated
November 15, 2005
Record last verified: 2005-11
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Source: ClinicalTrials.gov.
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