Subjects preliminarily eligible who choose to receive PrEP will be included after obtaining the informed consent and confirmation of eligibility within 45 days after the screening visit. Once included, participants will be examined in a follow-up visit performed four weeks later and evaluated for evidence of seroconversion to HIV, medication compliance and clinical toxicity. The second follow-up visit will occur at 12th week and every 12 weeks successively (quarterly). Quarterly visits include HIV testing, serum creatinine and counseling on medication compliance and risk reduction. The study has a total of 6 visits plus 2 extra visits for those participants enrolled in the PK study. In all visits will be assessed the risks, HIV testing will be performed, monitoring of renal function and dispensing of the drug Truvada \[emtricitabine 1 tablet (FTC) / tenofovir (TDF) (200/300 mg) once a day orally for 12 months\]. Participants who have completed 48 weeks of follow-up or prematurely discontinue a PrEP will be encouraged to return for a follow-up visit after discontinuation of medication for monitoring of the status and evaluation of HIV as the resolution of side effects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
120
Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year
Instituto Nacional de Infectologia Evandro Chagas (INI) - Fiocruz
Rio de Janeiro, Brazil
RECRUITINGCompliance to study treatment
Number of volunteers who keep the study treatment during 24 months Correlation of socio-demographic factors of acceptance and refusal Duration of PrEP Side effects and toxicities, including elevations of creatinine Adherence to PrEP: number of tablets per day, patterns of adherence Number of male sexual partners, by serostatus and condom use, and episodes of anal sex by partner serostatus, the interviewee practices and condom use.
Time frame: 2 years
HIV seroconversions rate
Number of patients who become HIV-infected
Time frame: 2 years
Maximum Plasma Concentration [Cmax] of FTC / TDF
Compare FTC/TDF Cmax between volunteers using or not hormones
Time frame: 2 years
Area Under the Curve [AUC] of FTC / TDF
Compare FTC/TDF AUC between volunteers using or not hormones
Time frame: 2 years
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