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|
|Actual Primary Completion Date :||March 2011|
|Actual 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.
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|