Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy

This study has been completed.

Sponsor:

Information provided by:

Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT00312832

First received: April 7, 2006

Last updated: October 23, 2006

Last verified: January 2004

History of Changes

Purpose

Background: Stavudine-containing regimens are associated with a potential for lipoatrophy and dyslipidemia. We assessed the safety and efficacy of reducing the dose of stavudine compared to switching to tenofovir or maintaining the standard dose of stavudine.

Methods: Clinically stable lipoatrophic HIV-infected patients receiving antiretroviral therapy containing stavudine 40 mg bid with a plasma HIV RNA <200 copies/mL for at least 6 months were randomized to maintain stavudine 40 mg bid (d4T40 arm), to reduce to 30 mg bid (d4T30 arm), or to switch from stavudine to tenofovir-DF (TDF arm) while preserving the remaining drugs. Fasting metabolic parameters were assessed at baseline and at weeks 4, 12, and 24. Mitochondrial parameters in peripheral blood mononuclear cells and body composition were measured at baseline and at week 24.

Condition	Intervention
HIV Infections Lipoatrophy	Drug: switching; dose reduction


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Open Label Study Comparing the Impact of Reducing the Dose of Stavudine Versus Switching to Tenofovir on Plasma Lipids, Body Composition and Mitochondrial Function in HIV-Infected Patients Receiving Antiretroviral Therapy

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Stavudine

Genetic and Rare Diseases Information Center resources: Lipodystrophy

U.S. FDA Resources

Further study details as provided by Hospital Clinic of Barcelona:


Estimated Enrollment:	60
Study Start Date:	January 2004
Estimated Study Completion Date:	February 2005

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Study eligibility criteria included documented HIV infection, age 18 years or older, moderate to severe clinical lipoatrophy in at least one region upon physical examination (17,18), viral load <200 copies/mL for at least 6 months prior to inclusion in the study, and a stable triple antiretroviral therapy including d4T 40 mg bid for at least the 6 preceding months, and no prior TDF use.

Exclusion Criteria:

Prior TDF use, viral load>200 copies.

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: NCT00312832

Sponsors and Collaborators

Hospital Clinic of Barcelona

Investigators


Principal Investigator:	Jose Maria Gatell	Hospital Clinic of Barcelona

More Information

No publications provided


ClinicalTrials.gov Identifier:	NCT00312832 History of Changes
Other Study ID Numbers:	D40-30
Study First Received:	April 7, 2006
Last Updated:	October 23, 2006
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:


HIV d4T TDF	lipoatrophy treatment experienced HIV-infection

ClinicalTrials.gov processed this record on March 03, 2015

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