Recruiting
Phase 1

Cabotegravir

Sponsor:

Johns Hopkins University

Code:

NCT07672717

Conditions

HIV

Prophylaxis

Injectable

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

Interventions

Cabotegravir Injectable Suspension (CAB LA)

Study Details

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

Study ID

NCT07672717

Start date

Jul 7, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2031

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Accepted

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 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

Exclusion Criteria:

  • 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)
  • At screening or within the past 2 months: participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal or genital infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts. HSV seropositivity with no active genital lesions is not an exclusion criterion. (Note: if an STI apart from HIV is detected, the participant will be referred for treatment and can be retested in 30 days and re-screened once.)
  • History of significant gastrointestinal bleeding
  • Clinically significant cardiovascular disease, as defined by history of symptomatic arrhythmia, ischemia, or other significant cardiac disease
  • Current use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \[>81 mg\], NSAIDs, or Pradaxa®)
  • Use of systemic or anorectal immunomodulatory medications within 4 weeks of enrollment or planned use at any time during study participation
  • Per participant report, use of any rectally or vaginally administered products containing N-9 (including condoms) or investigational products within 4 weeks of enrollment, or planned use of either at any time during study participation
  • Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements.
  • Individuals with neocervix will be excluded from giving cervical biopsies, if eligible for study participation.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Single arm for CHIPP-Prep: CAB

Interventions

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.

Primary outcome measure

  • Plasma CAB concentration [ Time Frame: 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 [ Time Frame: 0-12 weeks, AUC inf ]
  • Rectal Tissue CAB concentrations [ Time Frame: Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 12 ]
  • Rectal Fluid CAB concentrations [ Time Frame: Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 12 ]
  • Cervical Tissue CAB concentrations , in females only [ Time Frame: Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 12 ]
  • Cervicovaginal Fluid CAB concentrations, in females only [ Time Frame: Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 12 ]

Central Contacts and Locations

Central contacts

Pooja Akoijam

4109551201pakoija1@jh.edu

Jennifer Hoffmann

4109551318

Locations

Johns Hopkins School of Medicine, Drug Development Unit

Recruiting

Baltimore, Maryland, United States, 212187

Contacts

Pooja Akoijam

410-955-1201pakoija1@jh.edu

Deya Chatterji

4109551218dchatte5@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-13.