RBR-4x3cnp
Recruiting
未知
ImPrEP - Implementation of HIV Pre-exposure Prophylaxis (PrEP) for men who have sex with men and transgender individuals at high risk for HIV infection: A Demonstration Project in the context of Combination Prevention in Brazil, Mexico and Peru - ImPrEP: Implementation of HIV Pre-exposure Prophylaxis
Instituto Nacional de Infectologia vandro Chagas (INI) - Fiocruz0 sitesAugust 20, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Men who have sex with men (MSM) and transgender individuals (TG) who are at higher risk of acquiring HIV infection in Brazil, Mexico and Peru
- Sponsor
- Instituto Nacional de Infectologia vandro Chagas (INI) - Fiocruz
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male sex (at birth), except for transgender male; Willing and able to provide written informed consent; Age 18 years or older; HIV\-1\-uninfected defined as: Rapid HIV test negative at the enrollment visit; Evidence of risk for acquiring HIV\-1 infection including any one of the following: a.Condomless anal sex with male or transgender sex partners during the last 6 months; or b.Anal sex with at least one HIV\+ partner during the last 6 months; or c.Reported rectal or urethral gonorrhea or chlamydia or syphilis in the 6 months prior to enrollment or diagnosed at enrollment; or d.Reporting to exchange sex for money, gifts, shelter or drugs in the last 6 months; No previous history of renal disease.
Exclusion Criteria
- •Signs or symptoms of acute HIV infection; Creatinine clearance \< 60 ml/min as estimated by the Modification of Diet in Renal Disease (MDRD) formula; Previously diagnosed active and serious infections, including tuberculosis or osteomyelitis and all infections requiring parenteral antibiotic therapy (other than STIs requiring intramuscular injections of antibiotics); active clinically significant medical problems including poorly controlled cardiac disease (e.g., symptoms of ischemia, congestive heart failure), or previously diagnosed malignancy expected to require further treatment; History of pathological bone fractures not related to trauma; Receiving ongoing therapy with any of the following: ART, including nucleoside analogs, non\-nucleoside reverse transcriptase inhibitors, protease inhibitors (except for antiretrovirals used for PEP) or investigational anti\-retroviral agents, interferon (alpha, beta, or gamma) or interleukin (e.g., IL\-2\) therapy, agents with significant nephrotoxic potential, other agents that may inhibit or compete for elimination via active renal tubular secretion (e.g., probenecid), and/or other investigational agents; Concomitant participation in a clinical trial using investigational agents, including placebo\-controlled clinical trials using such agents.
Outcomes
Primary Outcomes
Not specified
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