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

HIV Infections Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00122668
• Other study ID #: ANRS121 HIPPOCAMPE
• Status: Terminated
• Phase: Phase 4
• First received: July 21, 2005
• Last updated: November 14, 2005
• Start date: November 2003
• Est. completion date: July 2005

Study information

• Verified date: November 2005
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 112
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• HIV-Associated Lipodystrophy Syndrome
• Lipodystrophy

Intervention

Drug:
• non-nucleoside reverse transcriptase inhibitors

• nucleoside reverse transcriptase inhibitors

• protease inhibitor

Locations

Country	Name	City	State
France	Service des Maladies infectieuses et Tropicales Hopital Pitie Salpetriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of subcutaneous fat in the limbs measured by DEXA and CT-scan of the thighs between baseline and Week 96
Secondary	During the study until 96 weeks
Secondary	Viro-immunologic efficacy: Proportion of patients with a plasma viral load below 400 and 50 copies/ml
Secondary	Evolution of viral load
Secondary	Evolution of CD4 lymphocytes
Secondary	Evaluation of clinical safety
Secondary	Evaluation of lipohypertrophic syndrome
Secondary	Evaluation of glucidic and lipids metabolic profile
Secondary	Evaluation of mitochondrial toxicity
Secondary	Evaluation of bone toxicity by measurement of bone density
Secondary	Evaluation of plasma trough concentration of protease inhibitors and non nucleoside reverse transcriptase inhibitors
Secondary	Evaluation of intracellular concentration of nucleoside reverse transcriptase inhibitors
Secondary	Evolution of quality of life using the World Health Organization Quality of Life in persons with HIV Brief Form (WHO-QOL-HIV BREF)