Health Trials

Characterization of Doxycycline Pharmacokinetics and Adherence

ConditionSexually Transmitted Infection
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHIV Prevention Trials Network

About this trial

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.

Eligibility criteria

Qualifiers

Aged 18 to 65 years of age at the time of screening

Able and willing to follow study participation requirements and provide informed consent to take part in the study

Has a non-reactive/negative HIV test results at screening per applicable algorithm

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

Disqualifiers

Per participant report, planned or active use of any anticonvulsants at screening and an unwillingness to restrict use of certain medications (iron, antacids, etc.) for the duration of the study

For females of reproductive potential: Pregnant or currently breastfeeding, or intends to become pregnant and/or breastfeed during the study

An estimated calculated creatinine clearance (CrCl) less than 60 mL/min by the Cockcroft-Gault formula at screening

Positive for hepatitis B surface antigen (HBsAg) at screening

Trial design

Treatments tested in this trial

  • Single-Dose PK Phase - DR Group
  • Single-Dose PK Phase - IR Group
  • Multi-Dose PK Phase - Daily Group
  • Multi-Dose PK Phase - Intermittent Group

Treatment groups

16 Participants
are divided into 4 treatment groups

Sponsors and collaborators

HIV Prevention Trials Network

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Source ClinicalTrials.gov