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Efavirenz (EFV) in HIV-Infected and HIV/Tuberculosis (TB) Coinfected Children

NCT00802802 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-11-01

No results posted yet for this study

Summary

Efavirenz (EFV) is an anti-HIV medicine that is commonly used to treat HIV infection in adults and children older than 3 years of age. This study is being conducted to look at the safety of EFV, blood levels of EFV, genetic factors that may affect blood levels of EFV, and how easy it is for infants and young children to take and tolerate EFV. This information will help recommend the best doses of EFV for children younger than 3 years of age.

Conditions

Interventions

DRUG

Efavirenz (EFV)

Participants will be administered oral EFV at a dose ranging from 50 mg to 800 mg once daily, based on weight and CYP 2B6 genotype. EFV capsules will be opened into a small amount of a compatible food or liquid vehicle; the smallest amount of food or liquid that will enable the child to swallow the capsule contents should be used (i.e., EFV should not be taken with a meal).

DRUG

Rifampin-containing anti-TB therapy

Treatment with rifampin-containing anti-TB treatment regimen. Treatment will last at least 24 weeks and up to 36 weeks.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Carolyn Bolton, MBBCh · UAB, CIDRZ

  • Mutsawashe Bwakura-Dangarembizi, MD · Univ. of Zimbabwe, AIDS Research Unit

  • Ellen Gould Chadwick, MD · Northwestern Univ. Feinberg School of Medicine - Dept. of Peds, Children's Memorial Hosp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-10
Primary Completion
2016-03-18
Completion
2018-02-16

Countries

  • India
  • South Africa
  • Uganda
  • Zimbabwe

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 NCT00802802 on ClinicalTrials.gov