HIV, PreventionPhase 4PrEParadasNCT03220152
Implementation of PrEP to HIV in Brazilian Transgender Women
A Phase 4 study testing emtricitabine / tenofovir 200/300 mg in people with HIV, Prevention, run by Oswaldo Cruz Foundation at 1 site in Brazil.
Trial summary
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. 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, Prevention
- 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
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jul 2017to Jul 2020
- Phase
- Phase 4
- 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) AND transgender women identity;
- 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 or vaginal sex without a condom with two or more men or transgender women in the last 12 months, or
Show all 12Show fewer
- 2 or more episodes of anal sex with at least one HIV+ sexual partner HIV + in the last 12 months, or
- Sex with a man or trans woman and diagnosis or report of any of the following STDs in the last 12 months: syphilis, rectal gonorrhea or chlamydial infection in the rectum.;
- Report of exchanging sex for money, presents, shelter or drugs.
- 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
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Nacional de Infectologia Evandro Chagas (INI) - Fiocruz
Rio de Janeiro, 21040360
Beatriz Grinsztejn, PhD, 552122707064, gbeatriz@ini.fiocruz.br
About this study
Official title: Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV in Brazilian Transgender Women
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.
Read more
The study has a total of 6 visits plus 2 extra visits for those participants enrolled in the PK study. 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 48 weeks 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, Prevention
- 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 | Experimental | emtricitabine / tenofovir 200/300 mg 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.
Compliance to study treatment
Number of volunteers who keep the study treatment during 24 months 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: 2 years
Secondary outcomes (3)
HIV seroconversions rate
Number of patients who become HIV-infected
Measured: 2 years
Maximum Plasma Concentration [Cmax] of FTC / TDF
Compare FTC/TDF Cmax between volunteers using or not hormones
Measured: 2 years
Area Under the Curve [AUC] of FTC / TDF
Compare FTC/TDF AUC between volunteers using or not hormones
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start10 Jul 2017
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (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 HIV, PreventionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oswaldo Cruz Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220152
- Sponsor's protocol ID
- PrEParadas
- Acronym
- PrEParadas
- Status last verified
- Jul 2018
- First submitted
- 6 Jul 2017
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cattani VB, Jalil EM, Eksterman L, Torres T, Wagner Cardoso S, Castro CRV, Monteiro L, Wilson E, Bushman L, Anderson P, Veloso VG, Grinsztejn B, Estrela R; PrEParadas study team. Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre-Exposure Prophylaxis: Analysis of Potential Interactions. Clin Pharmacokinet. 2023 Jul;62(7):1031-1041. doi: 10.1007/s40262-023-01248-0. Epub 2023 Jun 1.
PubMed 37261664Jalil EM, Torres TS, Luz PM, Monteiro L, Moreira RI, de Castro CRV, Leite IDC, Cunha M, de Cassia Elias Estrela R, Ramos M, Hoagland B, Wagner Cardoso S, Anderson P, Veloso VG, Wilson E, Grinsztejn B; PrEParadas Study Team. Low PrEP adherence despite high retention among transgender women in Brazil: the PrEParadas study. J Int AIDS Soc. 2022 Mar;25(3):e25896. doi: 10.1002/jia2.25896.
PubMed 35255199
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Pre-Exposure Prophylaxis (PrEP) to HIV in Brazilian Transgender Women
- ClinicalTrials.gov ID
- NCT03220152
- Acronym / sponsor ID
- PrEParadas / PrEParadas
- Conditions
- HIV, Prevention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Oswaldo Cruz FoundationUniversity, hospital or other
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 18 Jul 2017 (actual)
- 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.
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 plus 2 extra visits for those participants enrolled in the PK study. 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 48 weeks 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 | Experimental | Drug: emtricitabine / tenofovir 200/300 mgemtricitabine / tenofovir 200/300 mg Fixed 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 (12 listed)
- Male (at birth) AND transgender women identity;
- 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
Compliance to study treatment
Time frame: 2 years
Number of volunteers who keep the study treatment during 24 months 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.
3 secondary outcomes
HIV seroconversions rate
Time frame: 2 years
Maximum Plasma Concentration [Cmax] of FTC / TDF
Time frame: 2 years
Area Under the Curve [AUC] of FTC / TDF
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Derived from this study: PubMed 37261664Cattani VB, Jalil EM, Eksterman L, Torres T, Wagner Cardoso S, Castro CRV, Monteiro L, Wilson E, Bushman L, Anderson P, Veloso VG, Grinsztejn B, Estrela R; PrEParadas study team. Estradiol and Spironolactone Plasma Pharmacokinetics Among Brazilian Transgender Women Using HIV Pre-Exposure Prophylaxis: Analysis of Potential Interactions. Clin Pharmacokinet. 2023 Jul;62(7):1031-1041. doi: 10.1007/s40262-023-01248-0. Epub 2023 Jun 1.
- Derived from this study: PubMed 35255199Jalil EM, Torres TS, Luz PM, Monteiro L, Moreira RI, de Castro CRV, Leite IDC, Cunha M, de Cassia Elias Estrela R, Ramos M, Hoagland B, Wagner Cardoso S, Anderson P, Veloso VG, Wilson E, Grinsztejn B; PrEParadas Study Team. Low PrEP adherence despite high retention among transgender women in Brazil: the PrEParadas study. J Int AIDS Soc. 2022 Mar;25(3):e25896. doi: 10.1002/jia2.25896.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing emtricitabine / tenofovir 200/300 mg in people with HIV, Prevention, run by Oswaldo Cruz Foundation at 1 site 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 12 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 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Beatriz Grinsztejn, MD (+55 21 22707064, gbeatriz@ini.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance to study treatment (time frame: 2 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 NCT03220152, 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 31 Jul 2018.