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| Descriptive Information Fields | |||||||||
| Brief Title † | Botswana Tenofovir Oral HIV Prophylaxis Trial | ||||||||
| 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 | ||||||||
| 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. |
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| 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 infection/disease, 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. |
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| Study Phase | Phase II, Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Primary Outcome Measure † | Adverse drug reactions in the tenofovir and placebo arms HIV incidence in the tenofovir and placebo arms |
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| Secondary Outcome Measure † | Changes in levels of unprotected sex during the trial Adherence to medication Antiretroviral (ARV) resistance patterns in seroconverters Viral set point in seroconverters |
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| Condition † | HIV Infection | ||||||||
| Intervention † | Drug: Tenofovir Disoproxil Fumarate 300 mg daily | ||||||||
| MEDLINE PMIDs | |||||||||
| Links | fact sheet on Botswana and Thailand Tenofovir trials  |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Terminated | ||||||||
| Enrollment † | 1200 | ||||||||
| Start Date † | September 2005 | ||||||||
| Completion Date | March 2007 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 29 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States, Botswana | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00111150 | ||||||||
| Organization ID | CDC-NCHSTP-4321 | ||||||||
| Secondary IDs †† | BOTUSA MB04 | ||||||||
| Study Sponsor † | Centers for Disease Control and Prevention | ||||||||
| Collaborators †† | Botswana Ministry of Health Gilead Sciences |
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| Investigators † |
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| Information Provided By | Centers for Disease Control and Prevention | ||||||||
| Verification Date | March 2007 | ||||||||
| First Received Date † | May 17, 2005 | ||||||||
| Last Updated Date | March 16, 2007 | ||||||||
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