HIVPrEPBrasilNCT01989611
Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.
A study testing emtricitabine / tenofovir 200/300 mg in people with HIV, run by Oswaldo Cruz Foundation at 3 sites in Brazil.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- emtricitabine / tenofovir 200/300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesBrazil
- Study dates
- Jun 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 2 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;
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Instituto de Pesquisa Clínica Evandro Chagas - IPEC / FIOCRUZ
Rio de Janeiro, Rio de Janeiro, 21040-360
Centro de Referência e Treinamento DST/AIDS
São Paulo, São Paulo
University of Sao Paulo - Hospital das Clínicas da Faculdade de Medicina da USP
São Paulo, São Paulo
About this study
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.
Read the 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.
- Conditions
- HIV
- Being tested
- emtricitabine / tenofovir 200/300 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emtricitabine / tenofovir 200/300 mgDrug
Also called Truvada
Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year
| Study group | Role | What they receive |
|---|---|---|
| emtricitabine / tenofovir 200/300 mg | Other | Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year. Receives: Drug: emtricitabine / tenofovir 200/300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: two years
Secondary outcomes (1)
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
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJun 2014
- Primary completionMar 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Centro de Referência e Treinamento DST/Aids
- Responsible party
- Sponsor
- Investigators
- Beatriz Grinsztejn, PhD, Principal investigator, Instituto de Pesquisa Clínica Evandro Chagas - Fiocruz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01989611
- Sponsor's protocol ID
- PrEP Brasil
- Other IDs
- 08405912.9.1001.5262
- Acronym
- PrEPBrasil
- Status last verified
- Oct 2015
- First submitted
- 30 Oct 2013
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31430318Grinsztejn 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.
PubMed 29467098
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV: A Demonstrative Project.
- ClinicalTrials.gov ID
- NCT01989611
- Acronym / sponsor ID
- PrEPBrasil / PrEP Brasil
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Centro de Referência e Treinamento DST/Aids
- Study start
- Jun 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| emtricitabine / tenofovir 200/300 mg | Other | Drug: emtricitabine / tenofovir 200/300 mgFixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| emtricitabine / tenofovir 200/300 mgAlso: TruvadaFixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year | Drug | emtricitabine / tenofovir 200/300 mg |
Primary outcome
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.
1 secondary outcome
Number of patients infected and relation with medication compliance (the measure is a composite - please see description)
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Derived from this study: PubMed 31430318Marins 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.
- Derived from this study: PubMed 29467098Grinsztejn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Grinsztejn, PhD principal investigator
Instituto de Pesquisa Clínica Evandro Chagas - Fiocruz
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emtricitabine / tenofovir 200/300 mg in people with HIV, run by Oswaldo Cruz Foundation at 3 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Different compliance evaluations (the measure is a composite - please see description) (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01989611, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.