HIV Clinical Trial
Official title:
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.
A prospective, open, multicenter,demonstrative of PrEP, which aims to assess the acceptability, feasibility and safety from chemoprophylaxis co-formulated emtricitabine / tenofovir disoproxil fumarate (FTC / TDF) administered orally, once daily, to MSM and transgender women . The demonstration project aims to include 400 participants over 12 months, with 200 at IPEC-Fiocruz, 100 at CRT-SP and 100 at USP.
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. 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 12 months 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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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