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

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00646984
First received: March 26, 2008
Last updated: March 28, 2008
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
HIV-Associated Lipodystrophy Syndrome
Drug: Standard continuous antiretroviral therapy
Drug: CD-4 guided therapy interruption
Drug: Viral load driven treatment interruption
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Strategies of Interruption/Reinitiation of Antiretroviral Therapy in Response to Immunologic/Virologic Changes in HIV-Infected Patients With Lipodystrophy.

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Limb fat content measured by dual X-ray absorptiometry [ Time Frame: 96 weekks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Other body composition analyses [ Time Frame: 96 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 147
Study Start Date: January 2002
Study Completion Date: April 2006
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard continuous antiretroviral therapy
Drug: Standard continuous antiretroviral therapy
Experimental: 2
CD-4 guided interruption arm
Drug: CD-4 guided therapy interruption
Stop antiretroviral therapy when CD-4 equal or above 350 and reinitiate when below 350
Experimental: 3
Viral load driven treatment interruption
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646984

Locations
Spain
Hospital Clinic of Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Study Director: Jose M Gatell, MD Hospital Clinic of Barcelona
  More Information

No publications provided

Responsible Party: Esteban Martinez, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00646984     History of Changes
Other Study ID Numbers: TARV-DEM-LD, AEM 01-0480
Study First Received: March 26, 2008
Last Updated: March 28, 2008
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
Lipodystrophy
Treatment interruption
HIV

Additional relevant MeSH terms:
Lipodystrophy
HIV-Associated Lipodystrophy Syndrome
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on July 29, 2014