Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122668
Status:
TERMINATED
Last Update Posted:
2005-11-15
First Post:
2005-07-21
Brief Title:
Evaluation of the Occurrence of Lipoatrophy in HIV-1 Infected Naive Patients
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 PIor a standard antiretroviral therapy with 2 NRTI plus PI or NNRTI
Patients were randomized 211 to either PINNRTI Gp1 or standard therapy 2NRTI either PI Gp2 or NNRTI Gp3 The study-treatment were lopinavirr 100400mg bid or indinavirr 100400mg 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 Absorptiometryand CT-scan of the thighs between baseline and W96
Patients were randomized 211 to either PINNRTI Gp1 or standard therapy 2NRTI either PI Gp2 or NNRTI Gp3 The study-treatment were lopinavirr 100400mg bid or indinavirr 100400mg 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 Absorptiometryand CT-scan of the thighs between baseline and W96
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None