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 - 0 Years
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