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Pharmacokinetics of Anti-TB Drugs in HIV/TB Co-infected Children in Ghana

NCT01687504 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 106

Last updated 2012-10-11

No results posted yet for this study

Summary

Tuberculosis (also known as TB) is a common infection and a major cause of death in children. Effective treatment using a combination of anti-tuberculosis (anti-TB) medications saves lives, but dosages of these medications are not well established in children. Several research studies have shown that the recommended dosages of the anti-TB medications in children do not lead to adequate blood levels to kill the bacteria in some children. This situation may lead to treatment failure and emergence of drug resistance. As a result, the world Health Organization (WHO) recently recommended increased dosages for all the TB medications in children. This study is being conducted to find out if the increased dosages of the anti-TB drugs are safe and lead to adequate drug levels in the blood of children with TB with or without HIV infection.

Conditions

Sponsors & Collaborators

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

    collaborator NIH

  • The Miriam Hospital

    lead OTHER

Principal Investigators

  • Awewura Kwara, MD, MPH&TM · The Miriam Hospital

Eligibility

Min Age
3 Months
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-05-31
Completion
2017-05-31

Countries

  • Ghana

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 NCT01687504 on ClinicalTrials.gov