RecruitingPhase 1NCT07672717

Cabotegravir-Hormone PK/PD Interactions for HIV Prevention

CHIPP-PrEP: Cabotegravir-Hormone Interrogation of Pharmacokinetics/Pharmacodynamics (PK/PD) for HIV Prevention

Sponsor

Johns Hopkins University

Enrollment

32 participants

Start Date

Jul 7, 2026

Study Type

INTERVENTIONAL

Conditions

HIV Prophylaxis Injectable

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cabotegravir Injectable Suspension (CAB LA) for people with hiv, injectable, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 19 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.