NCT01989611

Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Oswaldo Cruz Foundation · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	emtricitabine / tenofovir 200/300 mg	Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2013-11-21
• Last updated: 2015-10-12

Locations

3 sites across 1 country: Brazil