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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

October 30, 2013
November 14, 2013
January 2014
January 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01989611 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Prevention and Control
  • Preventive Measures
  • Preventive Therapy
  • Prophylaxis
  • HIV Not Infected Subjects
Drug: emtricitabine (FTC) / tenofovir (TDF)
Fixed dose combination of emtricitabine (FTC) / tenofovir (TDF) (200/300 mg) once daily orally
Other Name: Truvada
PrEP
Fixed dose combination of emtricitabine (FTC) / tenofovir (TDF) (200/300 mg) once daily orally.
Intervention: Drug: emtricitabine (FTC) / tenofovir (TDF)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
400
January 2016
January 2015   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
Yes
Brazil
 
NCT01989611
DemoPrEP, 08405912.9.1001.5262
No
Oswaldo Cruz Foundation
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
Oswaldo Cruz Foundation
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP