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

This study is not yet open for participant recruitment.
Verified November 2013 by Oswaldo Cruz Foundation
Sponsor:
Collaborators:
University of Sao Paulo
Centro de Referência e Treinamento DST AIDS
Information provided by (Responsible Party):
Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT01989611
First received: October 30, 2013
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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 Intervention
Prevention and Control
Preventive Measures
Preventive Therapy
Prophylaxis
HIV Not Infected Subjects
Drug: emtricitabine (FTC) / tenofovir (TDF)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.

Resource links provided by NLM:


Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • Different compliance evaluations [ Time Frame: two years ] [ Designated as safety issue: Yes ]
    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:
  • Number of patients infected and relation with medication compliance [ Time Frame: two years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 400
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
PrEP
Fixed dose combination of emtricitabine (FTC) / tenofovir (TDF) (200/300 mg) once daily orally.
Drug: emtricitabine (FTC) / tenofovir (TDF)
Fixed dose combination of emtricitabine (FTC) / tenofovir (TDF) (200/300 mg) once daily orally
Other Name: Truvada

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01989611

Locations
Brazil
Instituto de Pesquisa Clínica Evandro Chagas - IPEC / FIOCRUZ Not yet recruiting
Rio de Janeiro, RJ, Brazil, 21040-360
Contact: Beatriz Grinsztejn, PhD    552122707064    gbeatriz@ipec.fiocruz.br   
Principal Investigator: Beatriz Grinsztejn, PhD         
Sponsors and Collaborators
Oswaldo Cruz Foundation
University of Sao Paulo
Centro de Referência e Treinamento DST AIDS
Investigators
Principal Investigator: Beatriz Grinsztejn, PhD Instituto de Pesquisa Clínica Evandro Chagas - Fiocruz
  More Information

No publications provided

Responsible Party: Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT01989611     History of Changes
Other Study ID Numbers: DemoPrEP, 08405912.9.1001.5262
Study First Received: October 30, 2013
Last Updated: November 14, 2013
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Tenofovir
Tenofovir disoproxil
Emtricitabine
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on April 22, 2014