Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414518
Status:
COMPLETED
Last Update Posted:
2013-02-20
First Post:
2006-12-19
Brief Title:
Safety and Effectiveness of Short-Term Anti-HIV Drug Therapy for Recent HIV-1 Infection
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
An Open-Label Randomized Clinical Trial to Evaluate the Efficacy and Safety of Short Course Antiretroviral Therapy for Acute or Recent HIV-1 Infection in Zimbabwe and the United States
Status:
COMPLETED
Status Verified Date:
2013-01
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:
The purpose of this study is to determine the safety and effectiveness of an anti-HIV drug regimen followed by treatment interruption in people recently infected with HIV This study will also compare the effects of a treatment regimen including treatment interruption with a treatment plan based on clinical indicators
Detailed Description:
About 6 months after infection HIV viral load reaches a temporarily stable level known as virus set point Virus set point is different for each patient and can be a predictor for disease progression Preliminary studies indicate that early short-term antiretroviral therapy ART given to people newly infected with HIV may lead to lower virus set points and preserved CD4 counts However the length of short-term treatment needed to balance the possible adverse effects of ART with the achievement of lower virus set point is not yet known By lowering the virus set point and maintaining CD4 counts the need for long-term ART may be postponed The purpose of this study is to determine the safety and efficacy of a short course of ART on producing a lower virus set point in adults recently infected with HIV
This study will last at least 28 weeks Participants will be randomly assigned to one of two arms Arm A will receive ART for 12 weeks as emtricitabinetenofovir disoproxil fumarate TDFFTC daily and lopinavirritonavir LPVRTV in tablet form twice daily After 12 weeks treatment will be interrupted unless the CD4 count is measured to be less than 350 cellsmm3 on two consecutive occasions during treatment interruption If that occurs therapy will be resumed Participants in Arm B will receive no treatment until cluster of differentiation 4 CD4 counts drop below 350 cellsmm3 indicating ART is needed Study visits will occur at study entry at Weeks 2 and 4 and every 4 weeks thereafter At each study visit a physical exam blood collection and completion of an adherence questionnaire will occur Participants are encouraged to enroll in a related substudy that will evaluate HIV viral load in genital secretions
This study will last at least 28 weeks Participants will be randomly assigned to one of two arms Arm A will receive ART for 12 weeks as emtricitabinetenofovir disoproxil fumarate TDFFTC daily and lopinavirritonavir LPVRTV in tablet form twice daily After 12 weeks treatment will be interrupted unless the CD4 count is measured to be less than 350 cellsmm3 on two consecutive occasions during treatment interruption If that occurs therapy will be resumed Participants in Arm B will receive no treatment until cluster of differentiation 4 CD4 counts drop below 350 cellsmm3 indicating ART is needed Study visits will occur at study entry at Weeks 2 and 4 and every 4 weeks thereafter At each study visit a physical exam blood collection and completion of an adherence questionnaire will occur Participants are encouraged to enroll in a related substudy that will evaluate HIV viral load in genital secretions
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01AI055356 | NIH | None | httpsreporternihgovquickSearchP01AI055356 |