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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: Completed Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01479361 record still lists
NCT01479361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Atovaquone 750 mg twice daily is the first listed.
NCT01479361 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01479361's enrollment target sits among peer trials
36 1210th of 2000 higher than 743 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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