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

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Brief Title

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

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

Brief Summary

      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.
    



Study Type

Interventional




Condition

HIV Infections

Intervention

switching; dose reduction


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

60

Start Date

January 2004

Completion Date

February 2005


Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jose Maria Gatell, , 



Administrative Informations


NCT ID

NCT00312832

Organization ID

D40-30



Study Sponsor

Hospital Clinic of Barcelona


Study Sponsor

Jose Maria Gatell, Principal Investigator, Hospital Clinic of Barcelona


Verification Date

January 2004