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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.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00646984
Enrollment
147
Registered
2008-03-31
Start date
2002-01-31
Completion date
2006-04-30
Last updated
2008-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV-Associated Lipodystrophy Syndrome

Keywords

Lipodystrophy, Treatment interruption, HIV

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.

Interventions

DRUGStandard continuous antiretroviral therapy
DRUGCD-4 guided therapy interruption

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

DRUGViral 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

Sponsors

Hospital Clinic of Barcelona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Limb fat content measured by dual X-ray absorptiometry96 weekks

Secondary

MeasureTime frame
Other body composition analyses96 weeks

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026