How hormones affect long‑acting cabotegravir for HIV prevention
CHIPP-PrEP: Cabotegravir- Hormone Interrogation of Pharmacokinetics-Pharmacodynamics for HIV Prevention
['FUNDING_R01'] · JOHNS HOPKINS UNIVERSITY · NIH-11159781
This project looks at how natural and taken hormones change how the long‑acting HIV prevention injection cabotegravir behaves in the body for people at risk of HIV.
Quick facts
| Phase | ['FUNDING_R01'] |
|---|---|
| Study type | Nih_funding |
| Sex | All |
| Sponsor | JOHNS HOPKINS UNIVERSITY (nih funded) |
| Locations | 1 site (BALTIMORE, UNITED STATES) |
| Trial ID | NIH-11159781 on ClinicalTrials.gov |
What this research studies
From your perspective, the team wants to know whether hormones you make naturally or hormones you take (like birth control or gender‑affirming therapy) change how the long‑acting cabotegravir injection is absorbed, held in the body, and cleared. Researchers will analyze clinical trial data and biological samples, measuring hormone levels, body mass index, and injection site factors to see how these affect drug levels over time. They will use population pharmacokinetic modeling to predict cabotegravir concentrations in blood and in genital and rectal tissues across different people. The focus includes differences by sex and by use of exogenous hormones to better understand protection against HIV in real-world groups.
Who could benefit from this research
Good fit: Ideal candidates are people at risk of HIV who are using or considering long‑acting cabotegravir and people taking hormonal therapies (for contraception or gender‑affirming care).
Not a fit: People not using cabotegravir for prevention or people with no exposure to hormonal treatments may not see direct benefit from this work.
Why it matters
Potential benefit: If successful, this could support more personalized guidance or dosing so cabotegravir offers reliable protection for people on different hormone regimens and body types.
How similar studies have performed: Previous trials such as HPTN 077 found sex‑based differences in cabotegravir levels, but combining detailed hormone measurements with population PK modeling is a relatively new approach.
Where this research is happening
BALTIMORE, UNITED STATES
- JOHNS HOPKINS UNIVERSITY — BALTIMORE, UNITED STATES (ACTIVE)
Researchers
- Principal investigator: MARZINKE, MARK A — JOHNS HOPKINS UNIVERSITY
- Study coordinator: MARZINKE, MARK A
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Conditions: Acquired Immune Deficiency Syndrome Virus, Acquired Immunodeficiency Syndrome Virus