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Clinical Trials/RBR-4x3cnp
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.

Registry
who.int
Start Date
August 20, 2018
End Date
TBD
Last Updated
2 years ago
Study Type
Intervention
Sex
Male

Investigators

Sponsor
Instituto Nacional de Infectologia vandro Chagas (INI) - Fiocruz

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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