CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
Atovaquone 750 mg twice daily +1 moredrug
Likely dose
Atovaquone 750 mg twice dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01479361
NCT01479361Phase 1Completed

The Influence of Atazanavir-ritonavir and Efavirenz on Atovaquone Pharmacokinetics in HIV-infected Volunteers

National Institutes of Health Clinical Center (CC)·interventional·Posted Nov 24, 2011·Updated Jul 5, 2018

In Brief

A Phase 1 clinical trial evaluating Atovaquone 750 mg twice daily and Atovaquone 1500 mg twice daily for HIV and 2 related conditions. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV, PCP, Toxoplasmosis
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 24, 2011
Enrollment StartOct 31, 2011
Primary CompletionFeb 20, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.6 years ago

Interventions

Atovaquone 750 mg twice dailydrug

Atovaquone 1500 mg twice dailydrug