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

NCT00646984 | Completed Phase 4 DMC

• 2 other identifiers: TARV-DEM-LDAEM 01-0480
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV-Associated Lipodystrophy Syndrome

Keywords

Lipodystrophy; Treatment interruption; HIV

Outcome Measures

Primary Outcomes (1)

• Limb fat content measured by dual X-ray absorptiometry

  96 weekks

Secondary Outcomes (1)

• Other body composition analyses

  96 weeks

Study Arms (3)

1

ACTIVE COMPARATOR

Standard continuous antiretroviral therapy

Drug: Standard continuous antiretroviral therapy

2

EXPERIMENTAL

CD-4 guided interruption arm

Drug: CD-4 guided therapy interruption

3

EXPERIMENTAL

Viral load driven treatment interruption

Drug: Viral load driven treatment interruption

Interventions

Standard continuous antiretroviral therapy DRUG

1

CD-4 guided therapy interruption DRUG

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

2

Viral load driven treatment interruption DRUG

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

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic of Barcelona

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

HIV-Associated Lipodystrophy Syndrome; Lipodystrophy

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Skin Diseases, Metabolic; Skin Diseases; Skin and Connective Tissue Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jose M Gatell, MD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 31, 2008
• Study Start: January 1, 2002
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2006
• Last Updated: March 31, 2008

Record last verified: 2008-03

Locations

ES (1)