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

HIV-Associated Lipodystrophy Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00646984
• Other study ID #: TARV-DEM-LD
• Secondary ID: AEM 01-0480
• Status: Completed
• Phase: Phase 4
• First received: March 26, 2008
• Last updated: March 28, 2008
• Start date: January 2002
• Est. completion date: April 2006

Study information

• Verified date: March 2008
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: April 2006
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• HIV-Associated Lipodystrophy Syndrome
• Lipodystrophy

Intervention

Drug:
• Standard continuous antiretroviral therapy

• CD-4 guided therapy interruption
Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350
• Viral load driven treatment interruption
Stop antiretroviral therapy when viral load below 30,000 copies/ml and reinitiate when equal or above 30,000 copies/ml

Locations

Country	Name	City	State
Spain	Hospital Clinic of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Limb fat content measured by dual X-ray absorptiometry		96 weekks	Yes
Secondary	Other body composition analyses		96 weeks	Yes