Cabotegravir-Hormone PK/PD Interactions for HIV Prevention

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07672717
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • HIV
  • Injectable
  • Prophylaxis

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Cabotegravir Injectable Suspension (CAB LA) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Single arm for CHIPP-Prep: CAB

Primary Outcome Measure

Plasma CAB concentration [ Time Frame: Day 1 (24 h), Day 3 (72 h), Week 1, Week 2, Week 4, Week 8, and Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of Medicine, Drug Development UnitBaltimoreMaryland212187
Pooja Akoijam
[email protected]
410-955-1201
Deya Chatterji
[email protected]
4109551218

Find similar trials in Baltimore, MD

By condition
HIV
By specialty
Infectious disease
By research site
Johns Hopkins School of Medicine, Drug Development Unit· Baltimore, MD

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