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

Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.

Sponsors

Lead Sponsor: Hospital Clinic of Barcelona

Source 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.

Overall Status Completed
Start Date 2002-01-01
Completion Date 2006-04-01
Primary Completion Date 2005-04-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Limb fat content measured by dual X-ray absorptiometry 96 weekks
Secondary Outcome
Measure Time Frame
Other body composition analyses 96 weeks
Enrollment 147
Condition
Intervention

Intervention Type: Drug

Intervention Name: Standard continuous antiretroviral therapy

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: CD-4 guided therapy interruption

Description: Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350

Arm Group Label: 2

Intervention Type: Drug

Intervention Name: Viral load driven treatment interruption

Description: Stop antiretroviral therapy when viral load below 30,000 copies/ml and reinitiate when equal or above 30,000 copies/ml

Arm Group Label: 3

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jose M Gatell, MD Study Director Hospital Clinic of Barcelona
Location
Facility: Hospital Clinic of Barcelona
Location Countries

Spain

Verification Date

2008-03-01

Responsible Party

Name Title: Esteban Martinez

Organization: Hospital Clinic of Barcelona

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: 1

Type: Active Comparator

Description: Standard continuous antiretroviral therapy

Label: 2

Type: Experimental

Description: CD-4 guided interruption arm

Label: 3

Type: Experimental

Description: Viral load driven treatment interruption

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov

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