Strategies of Interruption/Reinitiation of Antiretroviral Therapy in HIV-Infected Patients With Lipodystrophy

Phase 4

Completed

• Conditions: HIV-Associated Lipodystrophy Syndrome
• Interventions: Drug: Standard continuous antiretroviral therapy; Drug: CD-4 guided therapy interruption; Drug: Viral load driven treatment interruption

• Registration Number: NCT00646984
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

Aim: To assess the safety on the progression of HIV infection and the efficacy on the evolution of metabolic parameters and body fat of either viral load- or CD4 cell-driven strategies of intermittent treatment in chronically HIV-1-infected persons.

Design: Pilot, prospective, open, randomized, controlled 3-year study.

Setting and patients: University hospital. Patients with viral load \<200 copies/mL and CD4 cell count \>450/mm3 for at least the last 3 months. Three arms with 50 patients each, that will be randomized either to continue antiretroviral therapy, or to discontinue it as long as either HIV-1 RNA be lower than 30000 copies/mL or CD4 cell count be higher than 300/mm3.

Study end-points: evolution of plasma metabolic parameters, body fat, and bone mineral density; incidence of adverse effects due to antiretroviral therapy and symptoms consistent with acute retroviral syndrome; incidence of virological failure (plasma HIV-1 RNA \>200 copies/mL while on therapy), immunological failure (CD4 cell count \<200/mm3 while on therapy), or clinical failure (development of AIDS-defining illnesses); cost of antiretroviral therapy administered and time free of therapy in the arms assigned to intermittent treatment; and the evolution of T lymphocyte subpopulations and the development of proliferative and cytotoxic responses against HIV.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Primary Completion: 2005-04
• Study Completion: 2006-04
• Status Verified: 2008-03
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-28
• Last Update Submitted: 2008-03-28
• Study First Posted: 2008-03-31
• Last Update Posted: 2008-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 147

Inclusion Criteria

• HIV-infected patients
• On stable antiretroviral therapy
• Viral load below 200 copies/ml
• CD4 above 450 cells/mcl during last 3 months

Exclusion Criteria

• Weight variation higher than 10% compared with previous stable weight
• Active (CDC-C) opportunistic events
• Major depression or schizophrenia under psychiatric treatment
• Lack of clinical stability
• Pregnant women or planning pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Standard continuous antiretroviral therapy	Standard continuous antiretroviral therapy
2	CD-4 guided therapy interruption	CD-4 guided interruption arm
3	Viral load driven treatment interruption	Viral load driven treatment interruption

Primary Outcome Measures

Name	Time	Method
Limb fat content measured by dual X-ray absorptiometry	96 weekks

Secondary Outcome Measures

Name	Time	Method
Other body composition analyses	96 weeks

Trial Locations

Locations (1)

Hospital Clinic of Barcelona; 🇪🇸 Barcelona, Spain