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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01989611
Recruitment Status : Unknown
Verified October 2015 by Oswaldo Cruz Foundation.
Recruitment status was:  Active, not recruiting
First Posted : November 21, 2013
Last Update Posted : October 12, 2015
University of Sao Paulo
Centro de Referência e Treinamento DST AIDS
Information provided by (Responsible Party):
Oswaldo Cruz Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Drug: emtricitabine / tenofovir 200/300 mg Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.
Study Start Date : June 2014
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
emtricitabine / tenofovir 200/300 mg
Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year.
Drug: emtricitabine / tenofovir 200/300 mg
Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year
Other Name: Truvada

Primary Outcome Measures :
  1. Different compliance evaluations (the measure is a composite - please see description) [ Time Frame: two years ]
    Acceptance and refusal rates Correlation of socio-demographic factors of acceptance and refusal Duration of PrEP Side effects and toxicities, including elevations of creatinine Adherence to PrEP: number of tablets per day, patterns of adherence Number of male sexual partners, by serostatus and condom use, and episodes of anal sex by partner serostatus, the interviewee practices and condom use.

Secondary Outcome Measures :
  1. Number of patients infected and relation with medication compliance (the measure is a composite - please see description) [ Time Frame: two years ]
    Knowledge about PrEP Reasons for the choice and refusal of PrEP seroconversions rate Patterns of resistance to anti-HIV among people who become infected Self-reports of deviation (selling or sharing) of PrEP medication Space needs and staff social harm Prevalence of sexually transmitted diseases

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01989611

Instituto de Pesquisa Clínica Evandro Chagas - IPEC / FIOCRUZ
Rio de Janeiro, RJ, Brazil, 21040-360
Centro de Referência e Treinamento DST/AIDS
Sao Paulo, SP, Brazil
University of Sao Paulo - Hospital das Clínicas da Faculdade de Medicina da USP
Sao Paulo, SP, Brazil
Sponsors and Collaborators
Oswaldo Cruz Foundation
University of Sao Paulo
Centro de Referência e Treinamento DST AIDS
Principal Investigator: Beatriz Grinsztejn, PhD Instituto de Pesquisa Clínica Evandro Chagas - Fiocruz

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Oswaldo Cruz Foundation Identifier: NCT01989611     History of Changes
Other Study ID Numbers: PrEP Brasil
08405912.9.1001.5262 ( Registry Identifier: CAAE - Plataforma Brasil - IPEC / FIOCRUZ )
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents