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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00312832
First Posted: April 11, 2006
Last Update Posted: October 24, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital Clinic of Barcelona
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312832


Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Jose Maria Gatell Hospital Clinic of Barcelona
  More Information

ClinicalTrials.gov Identifier: NCT00312832     History of Changes
Other Study ID Numbers: D40-30
First Submitted: April 7, 2006
First Posted: April 11, 2006
Last Update Posted: October 24, 2006
Last Verified: January 2004

Keywords provided by Hospital Clinic of Barcelona:
HIV
d4T
TDF
lipoatrophy
treatment experienced
HIV-infection

Additional relevant MeSH terms:
HIV Infections
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Tenofovir
Stavudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents
Antimetabolites


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