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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| emtricitabine / tenofovir 200/300 mg | Drug | Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| HIV seroconversions rate | Number of patients who become HIV-infected | 2 years |
| Maximum Plasma Concentration [Cmax] of FTC / TDF | Compare FTC/TDF Cmax between volunteers using or not hormones |
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Inclusion Criteria:
Exclusion Criteria:
Male (at birth) AND transgender women identity;
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Grinsztejn, MD | Contact | +55 21 22707064 | gbeatriz@ini.fiocruz.br | |
| Emilia Jalil, MD | Contact | +55 21 22707064 | emilia.jalil@ini.fiocruz.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Nacional de Infectologia Evandro Chagas (INI) - Fiocruz | Recruiting | Rio de Janeiro | 21040360 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37261664 | Derived | 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. | |
| 35255199 |
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| ID | Term |
|---|---|
| D000068679 | Emtricitabine |
| D000068698 | Tenofovir |
| D000069480 | Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| 2 years |
| Area Under the Curve [AUC] of FTC / TDF | Compare FTC/TDF AUC between volunteers using or not hormones | 2 years |
| Derived |
| Jalil 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. |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |