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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for pre-exposure prophylaxis or PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.
75 subjects at risk for HIV infection (25 high risk MSM and 50 sero-discordant couples) will be recruited. All subjects will receive Truvada for PrEP, as well as routine medical evaluations during one year. Subjects will be managed according to CDC's guidelines on the management of PrEP as a tool for HIV prevention.
All subjects will have a total of at least 8 study visits during which routine assessment are performed for patients on Truvada for PrEP. Apart from offering routine medical care, a baseline questionnaire that includes socio-demographic variables, PrEP knowledge and acceptability and sexual conducts will be offered. At the 6 months visit, an abbreviated sexual conducts questionnaire will be offered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects at risk of HIV | Experimental | 25 high risk MSM and 50 negative partners in a sero-discordant couple will be recruited and emtricitabine and tenofovir (Truvada) for PrEP will be provided, per guidelines, for one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emtricitabine and Tenofovir | Drug | All subjects will be provided study drug for use daily for one year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Retention in care | Retention to follow up clinical visits based on completed and missed visits | 12 months |
| Treatment adherence | Determine adherence to study drug based on pill count and died blood spots (DBS) | 12 months |
| PrEP knowledge | Measure the level of education of the study subjects in the topic of PrEP using a questionnaire | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Study drug safety | Determine safety of study drug based on AE reports related to treatment | 12 months |
| Study drug safety | Determine safety of study drug based on safety laboratories monitoring, reported as percentage of participants with abnormal laboratory values |
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Inclusion Criteria:
Subject is a male, female or transgender female age 21 or older
Subject provides written informed consent.
Subject provides written authorization for use and disclosure of protected health information (PHI).
Subject has one of the following risk factors:
Baseline eCrCl of ≥60 ml/min (calculated using the CKD-EPI formula)
Negative Hepatitis B serology
No medical contraindications to the use of PrEP
Confirmed HIV negative by 5th generation (AB/antigen) HIV test
Exclusion Criteria:
Trans-gender female will be allowed in the study
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| Name | Affiliation | Role |
|---|---|---|
| Vivian M Tamayo-Agrait, MD | PR-CoNCRA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Puerto Rico Community Network for Clinical Research on AIDS (PR-CoNCRA) | San Juan | PR | 00928 | Puerto Rico |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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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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All subjects will receive same treatment with study drug
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| 12 months |
| HIV sero-prevalence | Determine the sero-prevalence of the study subjects receiving PrEP based on the number of study subjects diagnosed with HIV during study duration. | 12 months |
| Changes in sexual risk behaviors | Measure changes from baseline sexual risk behaviors after initiating use of study drug, specifically frequency of unprotected sexual intercourse according to sexual behaviors questionnaire. | 12 months |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| 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 |