The Interaction of Two HIV Medications With Blood Clot Medications in Healthy Volunteers
Status:
Completed
Trial end date:
2017-01-17
Target enrollment:
Participant gender:
Summary
Background:
- People who have the human immunodeficiency virus (HIV) often take several medications to
control their disease. They may also need to take medicine to prevent blood clots. Taking
both kinds of medicine together can cause bleeding or other problems. But this might not
happen if the medications are taken at different times. Researchers will study two particular
HIV drugs (ritonavir and cobicistat) and how they interact with blood clot medications.
Objectives:
-To understand how HIV medicine and blood clot medicine interact, so doctors can choose what
to prescribe for people who take both.
Eligibility:
- Healthy adults between 18 and 70 years old who are not on any medications.
Design:
- Participants will be screened with a physical exam and medical history. Blood samples
will be collected. Urine samples will be collected from participants who might become
pregnant.
- Participants will visit the National Institutes of Health 7 times after the screening
visit. Three visits will last about 12 hours. The other 4 will last about 1 hour.
- Participants will take a daily dose of either study medication for 22 days. They will
keep a diary of medicine they take and any side effects.
- Treatment will be monitored with blood tests over about 2 months.
- When the study of one drug is completed, the next drug study will begin with a different
group of participants.
Phase:
Phase 1
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)