Single Dose Truvada Study

Completed · Phase 1

Conditions studied: Medication Adherence, HIV Prevention

In brief

This study examines tenofovir (TFV) drug concentrations in adults one day after taking a single dose of Truvada® - a pill used to prevent and treat HIV infection. The results of this study will be used to improve the (efficacy/accuracy) of a white coat adherence (WCA) detection test - a blood test that can be used to indicate medication adherence. Participants will receive one dose of Truvada®, and provide 2 total samples of blood.

Key facts

Study ID

NCT03719053

Run by

Johns Hopkins University

People needed

44

Starts

2018-10-25

Expected to finish

2020-06-30

Last updated by the study team

2020-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy with no acute medical illness
• Willing to provide written informed consent
• Age 18 years of age or older
• Negative qualitative urine pregnancy test at screening and on day of dosing, prior to dosing, female participants only
• HIV-1 negative at screening, as documented by Combo Ag/Ab HIV-1/HIV-2 immunoassay
• At screening, no evidence of hepatic or renal impairment [creatinine clearance > 60 ml/min, total bilirubin ≤ upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.5 ULN]

You may not qualify if…

• Concomitant antiretroviral or other medication use, for which there is a known risk of pharmacokinetic or pharmacodynamic drug interactions.
• Active medical or psychological condition that, in the opinion of the investigator, might put the volunteer at undue risk or interfere with the participation of the study.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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