Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111150
Status:
TERMINATED
Last Update Posted:
2007-03-19
First Post:
2005-05-17
Brief Title:
Botswana Tenofovir 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 Tenofovir Disoproxil Fumarate for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana
Status:
TERMINATED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Consenting participants entered tenofoviremtricitabine oral prophylaxis trial
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will test whether taking a pill of tenofovir an antiretroviral medicine is safe for sexually-active young adults in Botswana without HIV infection and whether it will reduce their risk of getting an HIV infection
Detailed Description:
Twelve hundred healthy sexually active women and men 18-29 years old without HIV infection will be enrolled in Francistown and Gaborone Botswana They will be 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 will be randomized to receive either Tenofovir or a placebo pill to take once a day Volunteers will be 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 will receive 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 will be 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 MB04 | None | None | None |