Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448669
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2007-03-16
Brief Title:
Botswana TDFFTC Oral HIV Prophylaxis Trial
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
Status:
COMPLETED
Status Verified Date:
2016-02
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:
TDF2
Brief Summary:
This study tested whether taking a pill of tenofovir and emtricitabine two antiretroviral medicines was safe for sexually-active young adults in Botswana without HIV infection and whether it reduced their risk of getting an HIV infection
Detailed Description:
Twelve hundred and nineteen healthy sexually active women and men 18-39 years old without HIV infection were enrolled in Francistown and Gaborone Botswana They were provided with free male and female condoms repeated individualized risk-reduction counseling diagnosis and treatment of sexually transmitted diseases and women will be provided with a choice of effective family planning methods In addition volunteers were randomized to receive either Tenofovir and emtricitabine in a single pill or a placebo pill to take once a day Volunteers were seen monthly for at least 12 months to monitor for side effects and toxicities and to test their HIV status Persons who become HIV infected during the trial received ongoing supportive counseling CD4 and viral load monitoring education about HIV infectiondisease and access to HIV care including free antiretrovirals when clinically indicated Volunteer safety was monitored by a local ethics committee Centers for Disease Control Institutional Review Board CDC IRB and an independent data safety and monitoring board
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 |
|---|---|---|---|
| BOTUSA MB06 | OTHER | CDC-BOTUSA | None |