Antiretroviral Drug Interaction Study in Volunteers With HIV
Status:
Completed
Trial end date:
2014-02-20
Target enrollment:
Participant gender:
Summary
Background:
- People who are infected with the human immunodeficiency virus (HIV) are at risk of getting
certain diseases. Two of these diseases are a type of pneumonia known as PCP and a brain
infection called toxoplasmosis. Most people with HIV take antiretroviral (ARV) drugs to treat
HIV and lower the risk of infections. However, some ARV drugs may make other drugs used to
treat PCP and toxoplasmosis less effective. Researchers want to test specific ARV drugs to
see if they affect atovaquone, a drug used to treat PCP and toxoplasmosis.
Objectives:
- To see if ARV drugs atazanavir-ritonavir or efavirenz lower the blood levels of atovaquone.
Eligibility:
- Individuals between 18 and 70 years of age who have HIV.
- Participants must be taking efavirenz or atazanavir-ritonavir, or not taking any ARV
drugs.
Design:
- Participants will be screened with a physical exam and medical history. They will also
have blood and urine tests.
- This study has a screening visit and five study visits. Two of the study visits will
last about 12 hours; the other three visits will last about 1 hour each.
- Participants will receive either a low dose or high dose of atovaquone to take for 14
days. They will record doses and any symptoms on a diary card at home.
- After 14 days, participants will have a 12-hour visit to provide blood samples. There
will be a wash-out period with no doses for up to 6 weeks.
- After the wash-out period, participants will switch dose levels to either the high or
low dose.
- After 14 days, participants will have a 12-hour visit to provide blood samples.
Phase:
Phase 1
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)