Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project. (PrEPBrasil)
|ClinicalTrials.gov Identifier: NCT01989611|
Recruitment Status : Unknown
Verified October 2015 by Oswaldo Cruz Foundation.
Recruitment status was: Active, not recruiting
First Posted : November 21, 2013
Last Update Posted : October 12, 2015
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: emtricitabine / tenofovir 200/300 mg||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||April 2016|
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 Name: Truvada
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01989611
|Instituto de Pesquisa Clínica Evandro Chagas - IPEC / FIOCRUZ|
|Rio de Janeiro, RJ, Brazil, 21040-360|
|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, Brazil|
|Principal Investigator:||Beatriz Grinsztejn, PhD||Instituto de Pesquisa Clínica Evandro Chagas - Fiocruz|