Open Label Extension (OLE) of the TDF2 Study, Botswana (TDF2-OLE)
|ClinicalTrials.gov Identifier: NCT04318210|
Recruitment Status : Completed
First Posted : March 23, 2020
Last Update Posted : March 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||229 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open Label Extension (OLE) of the Study of the Safety and Efficacy of Daily Oral Antiretroviral Use for the Prevention of HIV Infection in Heterosexually Active Young Adults in Botswana|
|Actual Study Start Date :||October 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: TDF-FTC as PrEP
Eligible HIV-uninfected participants were offered 12 months of oral Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg (TDF-FTC) once daily in the form of a single tablet regardless of their original study assignment in randomized phase.
Drug: Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg
Other Name: Truvada
- Drug adherence [ Time Frame: Up to 12 Months ]A 30-day supply of TDF/FTC was dispensed at each monthly visit, for up to 12 months. Unused pills were retrieved and counted by study staff. Self-reported adherence measurements included a 3-day recall and a self-assessment scale (e.g., poor, fair, good, very good) to describe the overall adherence experienced in the past 30 days. DBSs were collected at each monthly study visit to characterize drug adherence by measuring extracellular tenofovir (TFV) for recent drug exposure and intracellular tenofovir-diphosphate (TFV-DP) for long-term drug exposure.
- Sexual behavior [ Time Frame: Up to 12 Months ]Sexual behavior was assessed at each scheduled monthly visit, for up to 12 months. Monthly sexual behavior questions included assessment of number of sexual partners, number of sex acts, and condom usage. HIV risk perception was assessed at study enrollment, month 6 and month 12. Perceived past risk was defined as feeling at risk for HIV in the past 6 months, whereas perceived future risk was defined as feeling at risk for HIV in the next 6 months, using a scale of high risk, medium risk, and low or no risk.
- HIV Seroconversion [ Time Frame: Up to 12 Months ]Study visits were scheduled every month until completion of the study and during monthly study visits, HIV testing was performed, for up to 12 months. During monthly visits, routine HIV testing was performed with two HIV rapid tests. If HIV-infection was suspected, HIV antigen-antibody (Ag/Ab) combination enzyme immunoassay (EIA) (Bio-Rad, GS HIV Combo Ag/Ab EIA) testing was performed, and RNA viral load was measured.
- Adverse events [ Time Frame: Up to 12 Months ]Study visits were scheduled every month until completion of the study (up to 12 months), and participants were instructed to return to the clinic for evaluation in the event of an illness. Participants reported any adverse effects at monthly visits and interim visits.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318210
|Principal Investigator:||Allan Taylor, MD, MPH||Centers for Disease Control and Prevention|