Characterization of Doxycycline Pharmacokinetics and Adherence Post-Single and Repeat Dosing Schemas
HIV Prevention Trials Network
Summary
The purpose of this study is to evaluate the effect of body changes on doxycycline concentrations for different dosing schedules. This study will involve a single dose phase and a multiple dose phase. Healthy individuals who do not have a sexually transmitted infection (STI), including acute (e.g., gonorrhea or chlamydia) or chronic (e.g., HIV or HSV-2) infections will be enrolled in this study. Study participants will be randomized to a dosing schedule in each phase and come to the research clinic throughout their time on study for sample collection. Study participants that choose to enroll in this study will be enrolled for about 37 days.
Description
Doxycycline is a Food and Drug Administration (FDA) approved broad-spectrum, second-generation tetracycline antibiotic that is generally well-tolerated and has been widely used as primary prophylaxis for bacterial and parasitic infections. While the pharmacokinetics (PK) of doxycycline in blood are well-described, knowledge gaps exist with intermittent dosing and establishing adherence thresholds for prophylactic use. Further, the multi-compartment distribution of the doxycycline has not been extensively characterized. The purpose of this study will be to characterize pharmacologic parameters…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Aged 18 to 65 years of age at the time of screening 2. Able and willing to follow study participation requirements and provide informed consent to take part in the study 3. Has a non-reactive/negative HIV test results at screening per applicable algorithm 4. Has and is able to maintain a caput (head) of hair, that has not been chemically treated (defined as hair that has been bleached, permed, relaxed or dyed/colored) and is greater than one centimeter in length for the duration of the study 5. For females of reproductive potential: Has a negative urine pregnancy test a…
Interventions
- DrugSingle-Dose PK Phase - DR Group
One 200 mg doxycycline hyclate delayed release (DR) tablet
- DrugSingle-Dose PK Phase - IR Group
Two 100 mg doxycycline hyclate immediate-release (IR) tablets
- DrugMulti-Dose PK Phase - Daily Group
One 200 mg doxycycline hyclate delayed release (DR) tablet every 24 hours
- DrugMulti-Dose PK Phase - Intermittent Group
One 200 mg doxycycline hyclate delayed release (DR) tablet every 72 hours
Location
- University of North Carolina at Chapel HillChapel Hill, North Carolina