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Antiretroviral Drug Interaction Study in Volunteers With HIV

NCT01479361 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2018-07-05

No results posted yet for this 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.

Conditions

  • HIV
  • PCP
  • Toxoplasmosis

Interventions

DRUG

Atovaquone 750 mg twice daily

DRUG

Atovaquone 1500 mg twice daily

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    lead NIH

Principal Investigators

  • Joseph A Kovacs, M.D. · National Institutes of Health Clinical Center (CC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-02-20
Completion
2014-02-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01479361 on ClinicalTrials.gov