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

October 7, 2015 updated by: Oswaldo Cruz Foundation
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 21040-360
        • Instituto de Pesquisa Clínica Evandro Chagas - IPEC / FIOCRUZ
    • SP
      • Sao Paulo, SP, Brazil
        • Centro de Referência e Treinamento DST/AIDS
      • Sao Paulo, SP, Brazil
        • University of Sao Paulo - Hospital das Clínicas da Faculdade de Medicina da USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • Truvada

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oswaldo Cruz Foundation

Collaborators

University of Sao Paulo
Centro de Referência e Treinamento DST AIDS

Investigators

  • Principal Investigator: Beatriz Grinsztejn, PhD, Instituto de Pesquisa Clínica Evandro Chagas - Fiocruz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

October 30, 2013

First Submitted That Met QC Criteria

November 14, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PrEP Brasil
  • 08405912.9.1001.5262 (Registry Identifier: CAAE - Plataforma Brasil - IPEC / FIOCRUZ)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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