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

• Status: Unknown status
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Oswaldo Cruz Foundation
• Collaborators: Centro de Referência e Treinamento DST AIDS; University of Sao Paulo
• Treatments: Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Tenofovir

Criteria

Inclusion Criteria:

• Male (at birth);

• Willing and able to provide informed consent in writing;

• Age = or > 18 years;

• not infected by HIV-1, in accordance with the flowchart of testing from Brazilian Ministry of Health;

• Evidence risk for acquiring HIV-1, including any of the following:

1. Anal sex without a condom with two or more men or transgender women in the last 12 months, or

2. 2 or more episodes of anal sex with at least one partner HIV + in the last 12 months, or

3. Sex with a man or trans woman and diagnosis of any of the following STDs in the last 12 months: syphilis, rectal gonorrhea or chlamydial infection in the rectum.

• Able to provide a residential address or contact phone itself, or two personal contacts who would know about his whereabouts during the study period demonstrative;

• Adequate renal function: Creatinine clearance > or = 60 ml / min, estimated by the formula modification of diet in renal disease (MDRD, from English 'Modification of Diet in Renal Disease') within 45 days of enrollment;

• urine Tape with negative result or showing only traces of protein within 45 days prior to enrollment;

Exclusion Criteria:

• Signs or symptoms of acute HIV infection,which is confirmed by laboratory examination in subsequent samples;

• Active and severe infections previously diagnosed, including active tuberculosis or osteomyelitis and all infections requiring parenteral antibiotics (except STD that require intramuscular injections of antibiotics);

• clinically significant active medical problems, including heart disease poorly controlled (eg, symptoms ischemia, congestive heart failure) previously diagnosed malignancy, or which will require additional treatment;

• Patients with positive tests for antigens of hepatitis B surface (HBsAg);

• History of pathological bone fractures unrelated to trauma;

• Patients using any of the following: ARV, including nucleoside inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors and antiretroviral agents under study, treatment with interferon (alpha, beta, or gamma) or interleukin (e.g. ,IL-2), with potential significant nephrotoxic agents, other agents which may inhibit or compete for renal elimination via active tubular secretion (eg probenecid) and / or other agents under study;

• Participation in a clinical trial using concomitant agents under investigation, including placebo-controlled trials using such agents;

• Patients who have any condition at the time of inclusion in the study, according to the opinion of the investigator, may prevent the provision of informed consent, make study participation unsafe, complicate data interpretation, or interfere anyway with the achievement of project objectives.