CHIPP-PrEP: Cabotegravir-Hormone Interrogation of Pharmacokinetics/Pharmacodynamics (PK/PD) for HIV Prevention
Johns Hopkins University
Summary
This is a research study to better understand how long-acting cabotegravir (CAB-LA) works to prevent HIV in people. This study will also evaluate the impact of endogenous and therapeutic hormones on CAB-LA pharmacology. The investigators will also evaluate if participants experience any medical problems when taking CAB-LA.
Description
The CHIPP-PrEP protocol is a phase 1, open label study to compare the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of long-acting cabotegravir injectable (CAB-LA) administration in adults aged 19 years or older. Long-acting cabotegravir (Apretude™) is an FDA-approved injectable antiretroviral medication administered every two months for HIV pre-exposure prophylaxis (PrEP). While clinical efficacy trials have demonstrated CAB-LA's effectiveness in preventing HIV infection, knowledge gaps remain regarding drug penetration into mucosal tissues where HIV transmission primarily occurs a…
Eligibility
- Age range
- 19+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 19 years of age or older * For persons using exogenous hormones, must be on a stable regimen for ≥6 months and remain on that regimen throughout study conduct, and exogenous hormone regimens must be prescribed and managed under the care of a healthcare professional * For females, must be on a non-hormonal contraceptive agent, and must persist in contraceptive use for the duration of the study * Body weight greater than 35 kg (77.2 lbs) * HIV-1 uninfected at screening and enrollment as documented by an instrumented Ag/Ab assay and HIV-1 RNA testing * Understand and agree…
Interventions
- DrugCabotegravir Injectable Suspension (CAB LA)
A single dose of 600 mg CAB-LA (ApretudeTM; 200 mg/mL) will be prescribed and administered only once during the study. ApretudeTM manufactured by ViiV Healthcare and is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular injection. The product is packaged in a 3 mL USP Type I glass vial with a 13 mm gray stopper and aluminum seal. Each vial is for single use containing a withdrawable fill of 2.0 mL and does not require dilution prior to administration. CAB LA injectable suspension is to be stored at up to 30°C, do not freeze. The dose selected is the FDA-recommended CAB-LA PrEP dose.
Location
- Johns Hopkins School of Medicine, Drug Development UnitBaltimore, Maryland