Botswana TDF/FTC Oral HIV Prophylaxis Trial (TDF2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00448669|
Recruitment Status : Completed
First Posted : March 19, 2007
Last Update Posted : October 2, 2012
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg Drug: TDF-FTC placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1219 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||March 2007|
|Primary Completion Date :||March 2011|
|Study Completion Date :||March 2011|
Active Comparator: TDF-FTC, condoms, risk counseling
Participants randomized to the active arm received daily oral TDF-FTC along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.
Drug: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg
Daily oral single dose pill containing 300 mg TDF and 200 mg FTC.
Other Name: Truvada
Placebo Comparator: Placebo, condoms, risk counseling
Participants randomized to the placebo arm received a daily oral placebo tablet along with male and female condoms, personalized risk reduction counseling, adherence counseling, and routine monitoring for HIV infection, laboratory abnormalities, and adverse events.
Drug: TDF-FTC placebo
Placebo comparator for TDF-FTC
- Adverse drug reactions in the tenofovir/emtricitabine and placebo arms; [ Time Frame: monthly ]Participants reported any adverse effects at monthly visits.
- HIV incidence in the tenofovir/emtricitabine and placebo arms [ Time Frame: monthly ]Participants HIV status was checked monthly
- Secondary: Changes in levels of unprotected sex during the trial; [ Time Frame: quarterly ]Participants provided information about their sexual activity on a quarterly basis
- Adherence to medication; [ Time Frame: monthly ]Participants provided information about their adherence to medication on a quarterly basis. Pill counts were done monthly.
- Antiretroviral (ARV) resistance patterns in seroconverters; [ Time Frame: at time of seroconversion ]Participants who seroconverted had blood samples taken at the time of infection and at one month and six months post seroconversion to detect any HIV resistance mutations.
- Viral set point in seroconverters [ Time Frame: At time of seroconversion and six months afterward ]Participants who HIV seroconverted during the study had their CD4 count evaluated at the time of seroconversion and at 6 months post seroconversion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448669
|United States, Georgia|
|Centers for Disease Control and Prevention|
|Atlanta, Georgia, United States, 30333|
|BOTUSA HIV Prevention Research Unit|
|Francistown and Gaborone, Botswana|
|Principal Investigator:||Lynn A Paxton, MD, MPH||Centers for Disease Control and Prevention|