Cabotegravir-Hormone PK/PD Interactions for HIV Prevention
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorJohns Hopkins University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Cabotegravir Injectable Suspension (CAB LA)
DrugA 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.
Treatment groups
32 Participants
are divided into 1 treatment groupGroup A: Single arm for CHIPP-Prep: CABExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Plasma CAB concentration
Plasma CAB concentration in ng/mL, stratified by sex and therapeutic hormone status
Time frame
Day 1 (24 hours), Day 3 (72 hours), Week 1, Week 2, Week 4, Week 8, and Week 122
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
Time frame
0-12 weeks, AUC inf3
Rectal Tissue CAB concentrations
Rectal Tissue CAB concentrations in ng/mg, stratified by sex and therapeutic hormone status
Time frame
Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 124
Rectal Fluid CAB concentrations
Rectal Fluid CAB concentrations in ng/mg, stratified by sex and therapeutic hormone status
Time frame
Day 1 (24 hours), Week 1, Week 2, Week 4, Week 8, and Week 12Secondary outcomes
1
Serum Estradiol Concentration
Serum Estradiol Concentration in pg/mL, stratified by sex and therapeutic hormone status
Time frame
Baseline (enrollment), and Day 1 (24 hours), Day 3 (72 hours), Week 1, Week 2, Week 4, Week 8, and Week 122
Serum Testosterone Concentration
Serum Testosterone (free, total) Concentration in ng/dL, stratified by sex and therapeutic hormone status
Time frame
Baseline (enrollment), and Day 1 (24 hours), Day 3 (72 hours), Week 1, Week 2, Week 4, Week 8, and Week 123
Serum Luteinizing Hormone Concentration
Serum Luteinizing Hormone Concentration in mIU/mL, stratified by sex and therapeutic hormone status
Time frame
Baseline (enrollment), and Day 1 (24 hours), Day 3 (72 hours), Week 1, Week 2, Week 4, Week 8, and Week 124
Serum Follicle Stimulating Hormone Concentration
Serum Follicle Stimulating Hormone Concentration in mIU/mL, stratified by sex and therapeutic hormone status
Time frame
Baseline (enrollment), and Day 1 (24 hours), Day 3 (72 hours), Week 1, Week 2, Week 4, Week 8, and Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov