Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy
Information source: Hospital Clinic of Barcelona
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Lipoatrophy
Intervention: switching; dose reduction (Drug)
Phase: N/A
Status: Completed
Sponsored by: Hospital Clinic of Barcelona Official(s) and/or principal investigator(s):
Jose Maria Gatell, Principal Investigator, Affiliation: Hospital Clinic Barcelona
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.
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: January 2004
Ending date: February 2005
Last updated: October 23, 2006
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