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RECRUITINGPhase 1INTERVENTIONAL

Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers

DD-PrEP: Pharmacokinetic Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The goal of this study is to evaluate the pharmacokinetics of a one-time dosing of two F/TAF tablets over a 14-day period.

Who May Be Eligible (Plain English)

Who May Qualify: - ≥18 years of age, inclusive on the date of screening - Provides written willing to sign a consent form for the study - Good general health, as determined by medical history, physical examination, vital signs, screening laboratory tests - Non-reactive HIV test results within four weeks of enrollment - An estimated glomerular filtration rate (eGFR) of ≥ 70 mL/min/1.73 m2 via the CKD-EPI 2021 eGFRCr equation - Agrees to use condoms for all sexual events during study participation - Willing to abstain from oral PrEP use outside of study products for the duration of the study Who Should NOT Join This Trial: - History of oral PrEP (F/TDF or F/TAF) use in the preceding two months - Persons who have a reactive or positive HIV result from screening visit. - Positive hepatitis B surface antigen (HBsAg) test - Participants with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption - History of any behaviors that place the participant at high-risk for HIV acquisition (e.g., needle sharing, unprotected sex with ≥1 partner in the prior 2 weeks) - Taking concomitant medications that that are known inducers/inhibitors of P-gp that would effect TAF absorption - Pregnancy or lactation - Any other condition or prior therapy that, in the opinion of the investigator, would preclude willing to sign a consent form, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * ≥18 years of age, inclusive on the date of screening * Provides written informed consent for the study * Good general health, as determined by medical history, physical examination, vital signs, screening laboratory tests * Non-reactive HIV test results within four weeks of enrollment * An estimated glomerular filtration rate (eGFR) of ≥ 70 mL/min/1.73 m2 via the CKD-EPI 2021 eGFRCr equation * Agrees to use condoms for all sexual events during study participation * Willing to abstain from oral PrEP use outside of study products for the duration of the study Exclusion Criteria: * History of oral PrEP (F/TDF or F/TAF) use in the preceding two months * Persons who have a reactive or positive HIV result from screening visit. * Positive hepatitis B surface antigen (HBsAg) test * Participants with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption * History of any behaviors that place the participant at high-risk for HIV acquisition (e.g., needle sharing, unprotected sex with ≥1 partner in the prior 2 weeks) * Taking concomitant medications that that are known inducers/inhibitors of P-gp that would effect TAF absorption * Pregnancy or lactation * Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease

Treatments Being Tested

DRUG

tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg

One-time dose of two F/TAF tablets

Locations (1)

Johns Hopkins University School of Medicine
Baltimore, Maryland, United States