Tuberculosis | Rifampin and Nevirapine Interactions in Young Children
Tuberculosis research study
What is the primary objective of this study?
Nevirapine is the preferred nonnucleoside reverse transcriptase inhibitor (NNRTI) for treatment of HIV in children younger than 3 years old who have tuberculosis (TB) coinfection. However, there is very limited data on the drug-drug interactions between rifampin and nevirapine in children of this age group. The purpose of this study is to determine the effect of rifampin-containing anti-TB treatment on the blood levels of nevirapine in young children with HIV and TB coinfection. Also, the study will find out whether checking the genetic makeup of a child could help to determine the appropriate dose of nevirapine in the setting of concomitant anti-TB treatment.
Who is eligible to participate?
Inclusion Criteria: 1. HIV seropositive children with or without active TB 2. Aged 3 to 35 months old 3. Antiretroviral-naïve and meet criteria for initiation of antiretroviral therapy 4. Are available for follow-up until achievement of a study endpoint like completion of study or discontinuation of HAART, and/or PK sampling Exclusion Criteria: 1. Unable to obtain informed signed consent parent(s) or legal guardian 2. Have AIDS-related opportunistic infections other than TB, history of or proven acute hepatitis within 30 days of study entry, persistent vomiting, or diarrhea 3. Hemoglobin < 6 g/dl, white blood cells < 2500/mm3, serum creatinine > 1.5 mg/dl, AST and ALT > 2X upper limit of normal.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: October 2012
Completed Date: May 2017
Primary Outcome: Area under time curve (AUC) of nevirapine
Secondary Outcome: Number of children with grade 3 or 4 liver enzymes elevations compared to baseline, new onset of skin rash, nausea, vomiting or treatment modification due to drug side effects
Study sponsors, principal investigator, and references
Lead Sponsor: The Miriam Hospital
Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)