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NCT01479361 · ClinicalTrials.gov registry record · Phase 1
Antiretroviral Drug Interaction Study in Volunteers With HIV
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT01479361 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 36 participants.
The verdict
NCT01479361, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study 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.
Interventions
- DRUG Atovaquone 750 mg twice daily
- DRUG Atovaquone 1500 mg twice daily
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2011-10-31 |
| Est. Completion | 2014-02-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01479361
The ClinicalTrials.gov registry entry for NCT01479361 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Atovaquone 750 mg twice daily is the first listed.
NCT01479361 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01479361 about?
NCT01479361 is a clinical study titled "Antiretroviral Drug Interaction Study in Volunteers With HIV". 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 lo...
What is the current status of trial NCT01479361?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2011-10-31. Estimated completion is 2014-02-20.
What interventions are being tested in trial NCT01479361?
The interventions under investigation include: Atovaquone 750 mg twice daily (DRUG), Atovaquone 1500 mg twice daily (DRUG).
Who is sponsoring clinical trial NCT01479361?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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