|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00122655 |
|
Date of registration:
|
21/07/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Study Evaluating the Impact on Fat Distribution of Nucleoside Reverse Transcriptase Inhibitor (NRTI)-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy
|
|
Scientific title:
|
A Randomized Prospective Study Evaluating the Impact on Fat Distribution of NRTI-Sparing Regimens in Antiretroviral Experienced Patients With Lipoatrophy ANRS 108 NONUKE Study |
|
Date of first enrolment:
|
January 2001 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00122655 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Marc Antoine Valantin, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Service des Maladies Infectieuses Hopital Pitie-Salpetriere Paris |
|
|
Name:
|
Dominique Costagliola |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
INSERM U720 |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Males and non-pregnant females
- Confirmed laboratory diagnosis of HIV infection
- Patients receiving a 2 or 3 NRTI-containing antiretroviral treatment for at least 3
months
- Viral load below 400 copies/ml
- Patients with a clinical peripheral lipoatrophy isolated or associated with a
lipohypertrophy self reported by the patient and confirmed by physical examination
Exclusion Criteria:
- Current antiretroviral therapy with 3 classes of antiretroviral therapy
- Previous virologic failure with a non-nucleoside reverse transcriptase inhibitor
(NNRTI) or protease inhibitor (PI)
- Intolerance to nevirapine and efavirenz
- Acute opportunistic infection
- Diabetes
- Transaminase levels over 5 times above the upper normal limit
- Hepatitis B virus (HBV) co-infection if the patient is receiving lamivudine therapy
- Ongoing immunotherapy including interleukin-2 (IL-2) and interferon
- Pregnancy or planned pregnancy
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
HIV Lipodystrophy Syndrome
|
|
HIV Infections
|
|
Intervention(s)
|
|
Drug: protease inhibitors
|
|
Drug: nucleoside reverse transcriptase inhibitors
|
|
Drug: non-nucleoside reverse transcriptase inhibitors
|
|
Primary Outcome(s)
|
|
Evolution from inclusion to week 48 of the peripheral fat tissue measured on computed tomography (CT) scan by a volumetric fat centralized evaluation of the thighs
|
|
Secondary Outcome(s)
|
|
Evolution of SAT/TAT and VAT/TAT between D0 and week 48
|
|
Change in lipid profile and glucidic metabolism between D0 and week 48
|
|
Change in CD4 cell count between day 0 (D0) and week 48
|
|
Evolution of the viral load (VL) from inclusion to week 48 and proportion of patients with a VL over 400 copies/ml at week 48
|
|
Secondary ID(s)
|
|
ANRS108 NONUKE
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|