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

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: HIV-Associated Lipodystrophy Syndrome

Treatments: Drug: Standard continuous antiretroviral therapy; Drug: Viral load driven treatment interruption; Drug: CD-4 guided therapy interruption

Study type: Interventional

Funder types: Other

Identifiers

NCT00646984

TARV-DEM-LD

AEM 01-0480

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 3 patient groups

1

Active Comparator group

Description:

Standard continuous antiretroviral therapy

Treatment:

Drug: Standard continuous antiretroviral therapy

2

Experimental group

Description:

CD-4 guided interruption arm

Treatment:

Drug: CD-4 guided therapy interruption

3

Experimental group

Description:

Viral load driven treatment interruption

Treatment:

Drug: Viral load driven treatment interruption