Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074581
Status:
COMPLETED
Last Update Posted:
2021-11-05
First Post:
2003-12-16
Brief Title:
Preventing Sexual Transmission of HIV With Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
Status:
COMPLETED
Status Verified Date:
2016-11
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:
This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not
Detailed Description:
Initiation of antiretroviral therapy ART in the HIV infected population has been shown to dramatically reduce the morbidity and mortality of HIV infection through sustained reduction in HIV viral replication However such therapy does not cure HIV infection or prevent the spread of the virus ART may however make HIV infected people less contagious by lowering plasma HIV-1 RNA levels compared with people not on ART This study seeks to determine whether initiating ART in ART-naive HIV infected people can prevent the sexual transmission of HIV among HIV-discordant couples as well as to demonstrate whether quality of life changes with the initiation of ART Both opposite and same sex couples will be recruited at study sites in Brazil India Malawi Thailand the United States and Zimbabwe for this study
Participating couples will be enrolled for approximately 78 months 65 years Couples will be randomly assigned to one of two arms HIV infected partners in Arm 1 will begin ART in addition to receiving HIV primary care HIV infected partners in Arm 2 will receive HIV primary care When the CD4 count in these participants reaches 200 to 250 cellsmm3 drops below 200 cellsmm3 or develops an AIDS-defining illness they will initiate ART All couples will receive HIV counseling and have their urine and blood collected at screening and enrollment and at selected monthly quarterly and yearly intervals They will be asked to periodically report information about their adherence to the ART regimen
Note Per LoA5 on the Data and Safety and Monitoring Board DSMB recommendation as of May 10 2011 all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible
Participating couples will be enrolled for approximately 78 months 65 years Couples will be randomly assigned to one of two arms HIV infected partners in Arm 1 will begin ART in addition to receiving HIV primary care HIV infected partners in Arm 2 will receive HIV primary care When the CD4 count in these participants reaches 200 to 250 cellsmm3 drops below 200 cellsmm3 or develops an AIDS-defining illness they will initiate ART All couples will receive HIV counseling and have their urine and blood collected at screening and enrollment and at selected monthly quarterly and yearly intervals They will be asked to periodically report information about their adherence to the ART regimen
Note Per LoA5 on the Data and Safety and Monitoring Board DSMB recommendation as of May 10 2011 all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible
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 |
|---|---|---|---|
| 10068 | REGISTRY | DAIDS ES | None |