Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109603
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
2005-04-29
Brief Title:
Effect of Tenofovir Disoproxil Fumarate on Lipid Levels in HIV Infected Adults on Stable Anti-HIV Drug Therapy
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study to Determine the Impact on Dyslipidemia of the Addition of Tenofovir to Stable Background Antiretroviral Therapy in HIV-Infected Subjects
Status:
COMPLETED
Status Verified Date:
2012-10
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:
The purpose of this study is to determine the effect of the anti-HIV drug tenofovir disoproxil fumarate TDF on lipid levels in HIV infected adults on stable anti-HIV drug therapy
Study hypothesis The addition of TDF to stable background antiretroviral therapy in HIV infected individuals with dyslipidemia will result in a reduction of non-HDL after 12 weeks of treatment
Study hypothesis The addition of TDF to stable background antiretroviral therapy in HIV infected individuals with dyslipidemia will result in a reduction of non-HDL after 12 weeks of treatment
Detailed Description:
Use of highly active antiretroviral therapy HAART has resulted in significant reductions in morbidity and mortality among HIV infected people However significant adverse effects including dyslipidemia have been associated with HAART Dyslipidemia may cause elevations in serum total cholesterol low-density lipoprotein LDL cholesterol and triglyceride concentrations as well as a decrease in high-density lipoprotein HDL concentrations Dyslipidemia is of particular concern for patients receiving HAART because the condition is associated with increased risk for cardiovascular events TDF is an antiretroviral that has exhibited favorable lipid effects in several studies in HIV infected people but the mechanism for the observed lipid-lowering effect of TDF is unknown This study will evaluate the efficacy of TDF on lowering non-HDL in HIV infected adults currently on stable HAART HAART itself will not be provided by this study
This study will last 32 weeks Participants will be randomly assigned to one of two study arms Arm A participants will receive 12 weeks of TDF daily 4 weeks of no TDF 12 weeks of placebo daily then 4 weeks of no TDF Arm B participants will receive 12 weeks of placebo daily 4 weeks of no TDF 12 weeks of TDF daily then 4 weeks of no TDF Participants will continue to take their currently prescribed stable HAART regimen for the duration of the study There will be 13 study visits over the 32 weeks of the study Clinical assessments will occur at all visits blood and urine collection will occur at most visits
This study will last 32 weeks Participants will be randomly assigned to one of two study arms Arm A participants will receive 12 weeks of TDF daily 4 weeks of no TDF 12 weeks of placebo daily then 4 weeks of no TDF Arm B participants will receive 12 weeks of placebo daily 4 weeks of no TDF 12 weeks of TDF daily then 4 weeks of no TDF Participants will continue to take their currently prescribed stable HAART regimen for the duration of the study There will be 13 study visits over the 32 weeks of the study Clinical assessments will occur at all visits blood and urine collection will occur at most visits
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