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

NCT ID: NCT00646984

Last Updated: 2008-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

147 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV-Associated Lipodystrophy Syndrome

Keywords

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Lipodystrophy Treatment interruption HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Standard continuous antiretroviral therapy

Group Type ACTIVE_COMPARATOR

Standard continuous antiretroviral therapy

Intervention Type DRUG

2

CD-4 guided interruption arm

Group Type EXPERIMENTAL

CD-4 guided therapy interruption

Intervention Type DRUG

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

3

Viral load driven treatment interruption

Group Type EXPERIMENTAL

Viral load driven treatment interruption

Intervention Type DRUG

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

Interventions

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Standard continuous antiretroviral therapy

Intervention Type DRUG

CD-4 guided therapy interruption

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Hospital Clinic of Barcelona

Principal Investigators

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Jose M Gatell, MD

Role: STUDY_DIRECTOR

Hospital Clinic of Barcelona

Locations

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Hospital Clinic of Barcelona

Barcelona, , Spain

Site Status

Countries

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Spain

Other Identifiers

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AEM 01-0480

Identifier Type: -

Identifier Source: secondary_id

TARV-DEM-LD

Identifier Type: -

Identifier Source: org_study_id