Rifampin and Nevirapine Interactions in Young Children
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ClinicalTrials.gov Identifier: NCT01699633
Verified September 2012 by The Miriam Hospital. Recruitment status was: Recruiting
: October 4, 2012
Last Update Posted
: October 12, 2012
The Miriam Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.
Area under time curve (AUC) of nevirapine [ Time Frame: At week of 4 of HIV therapy ]
Compare nevirapine AUC0-12h between HIV-infected children without TB and those with TB, as well as in the absence of and presence of rifampin-containing anti-TB therapy in co-infected patients
Secondary Outcome Measures
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 [ Time Frame: Up to week 24 of HIV therapy ]
Compare frequency of adverse events as a measure of safety and tolerability between HIV-infected children with and without TB coinfection
Number of children with nevirapine 12-hour post-dose concentration (C12h) < 3000 ng/mL [ Time Frame: Week 4 of HIV therapy ]
Relationship between clinical factors (weight, gender, nutritional status) as well as genetic factors (CYP2B6, CYP3A4 polymorphisms) and nevirapine C12h will be investigated
Time to HIV-1 RNA suppression below 50 copies/mL and change in CD4 cell count from baseline [ Time Frame: Up to week 24 of HIV therapy ]
Relationship between nevirapine pharmacokinetics (AUC0-12h, C12h) and time to virologic suppression as well as increase in CD4 cell count from baseline in the combined study population
Peak concentration (Cmax) and concentration at 12-hours (C12h) post-dose of nevirapine [ Time Frame: At week 4 of therapy ]
Compare nevirapine Cmax and C12h between HIV-infected children without TB and those with TB, as well as in the absence of and presence of rifampin-containing anti-TB therapy in co-infected patients
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Ages Eligible for Study:
3 Months to 35 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Children aged 3 to 35 months with HIV infection with or without TB
HIV seropositive children with or without active TB
Aged 3 to 35 months old
Antiretroviral-naïve and meet criteria for initiation of antiretroviral therapy
Are available for follow-up until achievement of a study endpoint like completion of study or discontinuation of HAART, and/or PK sampling
Unable to obtain informed signed consent parent(s) or legal guardian
Have AIDS-related opportunistic infections other than TB, history of or proven acute hepatitis within 30 days of study entry, persistent vomiting, or diarrhea
Hemoglobin < 6 g/dl, white blood cells < 2500/mm3, serum creatinine > 1.5 mg/dl, AST and ALT > 2X upper limit of normal.