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Cabotegravir-Hormone PK/PD Interactions for HIV Prevention

NCT07672717 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

  • HIV
  • Prophylaxis
  • Injectable

Interventions

DRUG

Cabotegravir 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.

Sponsors & Collaborators

Principal Investigators

  • Mark A Marzinke · Johns Hopkins School of Medicine

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-07-07
Primary Completion
2030-12-31
Completion
2031-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07672717 on ClinicalTrials.gov