Cabotegravir-Hormone PK/PD Interactions for HIV Prevention

NCT07672717 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB00494387R01AI186440
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (6)

• Plasma CAB concentration

  Plasma CAB concentration in ng/mL, stratified by sex and therapeutic hormone status

  Day 1 (24 hours), Day 3 (72 hours), Week 1, Week 2, Week 4, Week 8, and Week 12

• Plasma CAB area under the concentration curve

  Plasma CAB area under the concentration curve in ng.h/mL from time 0 to week 12 (AUC0-Wk12) and infinity (AUC0-inf), stratified by sex and therapeutic hormone status

  0-12 weeks, AUC inf

• Rectal Tissue CAB concentrations

  Rectal Tissue CAB concentrations in ng/mg, stratified by sex and therapeutic hormone status

  Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 12

• Rectal Fluid CAB concentrations

  Rectal Fluid CAB concentrations in ng/mg, stratified by sex and therapeutic hormone status

  Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 12

• Cervical Tissue CAB concentrations , in females only

  Cervical Tissue CAB concentrations in ng/mg

  Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 12

• Cervicovaginal Fluid CAB concentrations, in females only

  Cervicovaginal Fluid CAB concentrations in ng/mg

  Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 12

Secondary Outcomes (6)

• Serum Estradiol Concentration

  Baseline (enrollment), and Day 1 (24 hours), Day 3 (72 hours), Week 1, Week 2, Week 4, Week 8, and Week 12

• Serum Testosterone Concentration

  Baseline (enrollment), and Day 1 (24 hours), Day 3 (72 hours), Week 1, Week 2, Week 4, Week 8, and Week 12

• Serum Luteinizing Hormone Concentration

  Baseline (enrollment), and Day 1 (24 hours), Day 3 (72 hours), Week 1, Week 2, Week 4, Week 8, and Week 12

• Serum Follicle Stimulating Hormone Concentration

  Baseline (enrollment), and Day 1 (24 hours), Day 3 (72 hours), Week 1, Week 2, Week 4, Week 8, and Week 12

• Cervical Tissue explant p24 antigen concentrations

  Baseline (enrollment), and Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 12

Study Arms (1)

Single arm for CHIPP-Prep: CAB

EXPERIMENTAL

Drug: Cabotegravir Injectable Suspension (CAB LA)

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.

Also known as: Apretude

Single arm for CHIPP-Prep: CAB

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 to local STI reporting requirements
• Willing to abstain from additional antiretroviral agents (including PrEP agents, F/TAF and F/TDF) during the duration of the study
• Willing to abstain from insertion of anything (drug, enema, penis, or sex toy) in the rectum or vagina for 72 hours before and 72 hours after each flexible sigmoidoscopy
• Willing to refrain from aspirin and NSAID use for one week before and after each study biopsy visit
• Willing and able to use condoms for all receptive anal intercourse and receptive vaginal intercourse for the duration of study participation
• Able and willing to communicate in English
• Able and willing to provide written informed consent to take part in the study
• Able and willing to provide adequate information for locator purposes
• Availability to return for all study visits, barring unforeseen circumstances
• Agree not to participate in other research studies involving drugs and/or medical devices for the duration of the study

You may not qualify if:

• History of previous long-acting antiretroviral use, including CAB-LA and long-acting lenacapavir
• History of oral PrEP (F/TDF, F/TAF) use within the prior eight weeks
• For females, if a participant is pregnant or plans to become pregnant during study duration
• For females, if the participant is actively breastfeeding
• For females, if the participant is post-menopausal or accessing exogenous hormone replacement therapy
• For females, has irregular menstrual cycles
• Has a tattoo or other dermatological condition which may interfere with product administration or interpretation of injection site reactions
• Surgically-placed or injected buttock implants or filler, per self-report
• One or more reactive or positive HIV test results at screening or enrollment, even if HIV infection is not confirmed
• Current known HIV-infected partner(s)
• Symptoms suggestive of acute HIV seroconversion at screening and enrollment
• Known or suspected allergy to CAB-LA
• Any ≥ Grade 2 laboratory abnormality at baseline as defined by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1 - July 2017, and Addendum 3 (Rectal Grading Tables for Use in Microbicide Studies)
• Significant rectal symptom(s) as determined by medical history or by participant self-report (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, history of inflammatory bowel disease, presence of symptomatic hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation)
• History of significant gastrointestinal bleeding

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Johns Hopkins School of Medicine, Drug Development Unit

Baltimore, Maryland, 212187, United States

RECRUITING

MeSH Terms

Interventions

cabotegravir

Study Officials

• Mark A Marzinke

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pooja Akoijam

CONTACT

4109551201; pakoija1@jh.edu

Jennifer Hoffmann

CONTACT

4109551318

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 29, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

US (1)