Assessment of a New "Boosting" Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers
Status:
Completed
Trial end date:
2018-07-02
Target enrollment:
Participant gender:
Summary
The study will be a randomized, open-label, cross-over clinical pharmacokinetic trial to
investigate a strategy for probenecid "boosting" in the setting of tenofovir disoproxil
fumarate (TDF)/emtricitabine (FTC) for HIV pre-exposure prophylaxis (PrEP). The study will be
conducted at the Indiana University Clinical Research Center. All samples will be processed
and the amount of tenofovir/FTC in plasma, blood, and urine, and tenofovir diphosphate and
emtricitabine in peripheral blood mononuclear cells will be determined using validated
analytical methods developed by the investigators at the University of Colorado. Probenecid
plasma and urine concentrations will also be measured using an in-house assay. Following
completion of the study, the secondary aim will be accomplished via analysis of selected
samples collected at baseline and following treatment. Those selected samples will be
assessed for urinary markers of proximal tubulopathy (urine total protein, albumin,
creatinine, phosphorus, retinol binding protein, and beta-2-microglobulin) and serum alkaline
phosphatase, osteocalcin, procollagen type 1 N propeptide, cystatin C, and creatinine to
determine if the probenecid boosting strategy does indeed lead to less potential renal and
bone toxicity.