Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00312832
Status:
COMPLETED
Last Update Posted:
2006-10-24
First Post:
2006-04-07
Brief Title:
Study Comparing Reducing the Dose of Stavudine Versus Switching to Tenofovir in HIV-Infected Patients Receiving Antiretroviral Therapy
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2004-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 copiesmL 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
Methods Clinically stable lipoatrophic HIV-infected patients receiving antiretroviral therapy containing stavudine 40 mg bid with a plasma HIV RNA 200 copiesmL 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None