Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy
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
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hiv-infections
Started Jan 2004
Shorter than P25 for not_applicable hiv-infections
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 7, 2006
CompletedFirst Posted
Study publicly available on registry
April 11, 2006
CompletedOctober 24, 2006
January 1, 2004
April 7, 2006
October 23, 2006
Conditions
Keywords
Interventions
Eligibility Criteria
You may not qualify if:
- Prior TDF use, viral load\>200 copies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose Maria Gatell
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 7, 2006
First Posted
April 11, 2006
Study Start
January 1, 2004
Study Completion
February 1, 2005
Last Updated
October 24, 2006
Record last verified: 2004-01