NCT03800407Completed
Contributing Factors for Poor HIV Treatment Response in Children With TB/HIV Coinfection
Pharmacokinetics of Anti-tuberculosis and Antiretroviral Drugs in Children
Source: ClinicalTrials.gov · Last updated 8 Aug 2025
Brief summary (registry, in English)
Efavirenz (EFV)-based antiretroviral therapy (ART) remains the preferred regimen in human immunodeficiency virus (HIV)-infected children aged 3 years or older on rifampin-containing antituberculosis (anti-TB) therapy. This is because drug interactions between first-line anti-TB therapy with protease inhibitors (PIs) are more severe to adjust for, and interactions with integrase strand transfer inhibitors (INSTIs) are not well studied in that age group. Although, current weight-based EFV dosing recommendation is not optimal in some children, pharmacokinetic-treatment response (PK-PD) data to guide optimal dosing of EFV during concurrent rifampin-containing therapy in children is very limited. The study team propose that EFV concentrations outside the optimal therapeutic range in children will be associated with virologic failure due to lack of efficacy because of low concentrations or increased central nervous system (CNS) toxicities from high concentrations leading to poor medication adherence. The study will determine virological suppression rates in HIV-infected children with and without TB coinfection treated with standard efavirenz-based therapy and examine the factors contributing to poor virologic response.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 213 (actual)
- First submitted
- 3 Jan 2019
- Start date
- 28 Jan 2019
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- University of Florida
- Diseases
- Tuberculosis, HIV
- NCT number
- NCT03800407
What you commit to
- Study type: Observational
- Participants enrolled: 213
- From 28 Jan 2019 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Have AIDS-related opportunistic infections other than TB
- History of acute hepatitis within 30 days of study entry
Lab values
- Hemoglobin \< 6 g/dl, white blood cells \< 2500/mm3, serum creatinine \> 1.5 mg/dl, aspartate transaminase (AST) and alanine transaminase (ALT) \> 2 times upper limit of normal
Other
- Unable to obtain informed signed consent parent(s) or legal guardian
- Persistent vomiting or diarrhea at time of enrolment
Who the study is looking for
- HIV seropositive children with or without active TB
- Antiretroviral-naïve to efavirenz and meet criteria for initiation or switch to efavirenz-based ART
- Are available for follow-up until achievement of a study endpoint like completion of study at 6 months or discontinuation of ART.
Age in the registry: 3 years to 14 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kwame Nkrumah University of Science and Technology Coordinator of this site? Confirm its status | Kumasi | Ghana | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.