Understanding HIV treatment challenges in children with TB
Pharmacokinetics of Anti-tuberculosis and Antiretroviral Drugs in Children
University of Florida · NCT03800407
This study is trying to find out how to improve HIV treatment for children who also have tuberculosis by looking at how different factors affect a key medication called efavirenz.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 382 (estimated) |
| Ages | 3 Years to 14 Years |
| Sex | All |
| Sponsor | University of Florida (other) |
| Locations | 1 site (Kumasi) |
| Trial ID | NCT03800407 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the factors contributing to poor treatment responses in HIV-infected children who also have tuberculosis (TB). It focuses on the pharmacokinetics of efavirenz (EFV), a key antiretroviral medication, and how its effectiveness may be influenced by concurrent TB therapy, genetic factors, and adherence levels. The study aims to identify optimal EFV dosing strategies to improve virologic outcomes in this vulnerable population. By analyzing data from children with TB/HIV coinfection, the researchers hope to better understand the relationship between drug concentrations and treatment success.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV-positive children aged 3 years or older who are either starting or switching to efavirenz-based antiretroviral therapy and may have active TB.
Not a fit: Patients with AIDS-related opportunistic infections other than TB or those with severe health issues such as acute hepatitis or significant blood abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for HIV-infected children with TB, enhancing their virologic response and overall health outcomes.
How similar studies have performed: While previous studies have explored aspects of HIV treatment in children, this specific investigation into the interactions between efavirenz and TB therapy in this demographic is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Unable to obtain informed signed consent parent(s) or legal guardian * Have AIDS-related opportunistic infections other than TB * History of acute hepatitis within 30 days of study entry * Persistent vomiting or diarrhea at time of enrolment * 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
Where this trial is running
Kumasi
- Kwame Nkrumah University of Science and Technology — Kumasi, Ghana (RECRUITING)
Study contacts
- Principal investigator: Awewura Kwara, MD — University of Florida
- Study coordinator: Awewura Kwara, MD
- Email: awewura.kwara@medicine.ufl.edu
- Phone: 3522739501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tuberculosis, Human Immunodeficiency Virus, Coinfection, Pharmacokinetic, Concurrent antituberculosis therapy, Efavirenz, Virologic response, Children