NCT01989611

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

October 12, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

October 30, 2013

Last Update Submit

October 7, 2015

Conditions

HIV

Outcome Measures

Primary Outcomes (1)

  • Different compliance evaluations (the measure is a composite - please see description)

    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 Outcomes (1)

  • Number of patients infected and relation with medication compliance (the measure is a composite - please see description)

    two years

Study Arms (1)

emtricitabine / tenofovir 200/300 mg

OTHER

Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year.

Drug: emtricitabine / tenofovir 200/300 mg

Interventions

emtricitabine / tenofovir 200/300 mgDRUG

Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year

Also known as: Truvada
emtricitabine / tenofovir 200/300 mg

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Anal sex without a condom with two or more men or transgender women in the last 12 months, or
  • or more episodes of anal sex with at least one partner HIV + in the last 12 months, or
  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Instituto de Pesquisa Clínica Evandro Chagas - IPEC / FIOCRUZ

Rio de Janeiro, Rio de Janeiro, 21040-360, Brazil

Location

Centro de Referência e Treinamento DST/AIDS

São Paulo, São Paulo, Brazil

Location

University of Sao Paulo - Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, São Paulo, Brazil

Location

Related Publications (2)

  • Marins LMS, Torres TS, Leite IDC, Moreira RI, Luz PM, Hoagland B, Kallas EG, Madruga JV, Liu AY, Anderson PL, Grinsztejn B, Veloso VG. Performance of HIV pre-exposure prophylaxis indirect adherence measures among men who have sex with men and transgender women: Results from the PrEP Brasil Study. PLoS One. 2019 Aug 20;14(8):e0221281. doi: 10.1371/journal.pone.0221281. eCollection 2019.

    PMID: 31430318DERIVED

  • Grinsztejn B, Hoagland B, Moreira RI, Kallas EG, Madruga JV, Goulart S, Leite IC, Freitas L, Martins LMS, Torres TS, Vasconcelos R, De Boni RB, Anderson PL, Liu A, Luz PM, Veloso VG; PrEP Brasil Study Team. Retention, engagement, and adherence to pre-exposure prophylaxis for men who have sex with men and transgender women in PrEP Brasil: 48 week results of a demonstration study. Lancet HIV. 2018 Mar;5(3):e136-e145. doi: 10.1016/S2352-3018(18)30008-0. Epub 2018 Feb 18.

    PMID: 29467098DERIVED

MeSH Terms

Interventions

EmtricitabineTenofovirEmtricitabine, Tenofovir Disoproxil Fumarate Drug Combination

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDrug CombinationsPharmaceutical Preparations

Study Officials

  • Beatriz Grinsztejn, PhD

    Instituto de Pesquisa Clínica Evandro Chagas - Fiocruz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 21, 2013

Study Start

June 1, 2014

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

October 12, 2015

Record last verified: 2015-10

Locations

BR(3)