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

HIV Clinical Trial

— PrEPBrasil  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01989611
• Other study ID #: PrEP Brasil
• Secondary ID: 08405912.9.1001.
• Status: Active, not recruiting
• Phase: N/A
• First received: October 30, 2013
• Last updated: October 7, 2015
• Start date: June 2014
• Est. completion date: April 2016

Study information

• Verified date: October 2015
• Source: Oswaldo Cruz Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of HealthBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto de Pesquisa Clínica Evandro Chagas - IPEC / FIOCRUZ	Rio de Janeiro	RJ
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	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
Oswaldo Cruz Foundation	Centro de Referência e Treinamento DST AIDS, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of patients infected and relation with medication compliance (the measure is a composite - please see description)	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	No