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
Qualifiers
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
Treatments tested in this trial
- Cabotegravir Injectable Suspension (CAB LA)
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov