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HIV | Rifampin and Efavirenz Interactions in Older Children

HIV research study

What is the primary objective of this study?

Efavirenz is an essential component of HIV treatment in children aged 3 years or older on anti-tuberculosis (anti-TB) treatment. However, the appropriate efavirenz dose during anti-TB treatment remains unclear. Rifampin (an anti-TB drug) increases the activity of the drug metabolizing enzymes that breakdown efavirenz, which may lead to low blood levels of efavirenz and treatment failure during cotreatment. The drug-to-drug interactions between the HIV and anti-TB drugs also vary between individuals based on genetic factors. This study will investigate the effects of anti-TB treatment, as well as drug-gene interactions on the blood concentrations of efavirenz in children with HIV and TB infections. Such data could enhance optimization of efavirenz dosage or selection of alternate regimens in some children.

Who is eligible to participate?

Inclusion Criteria: 1. Children with active TB with or without HIV co-infection. Active TB diagnosis defined by clinical criteria consistent with active TB and/or a positive AFB smear or mycobacterial culture. 2. Aged 3 months to 14 years old 3. Are available for follow-up until completion of TB treatment and/or achievement of a study endpoint like discontinuation of therapy, and/or pharmacokinetic 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?

HIV

Tuberculosis

Study Interventions

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.

Study Arms

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.

Study Status

Unknown status

Start Date: October 2012

Completed Date: May 2017

Phase:

Type: Observational

Design:

Primary Outcome: Area under time curve from time 0-24 hours(AUC0-24h) of efavirenz

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

Principal Investigator:

Lead Sponsor: The Miriam Hospital

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

More information:https://clinicaltrials.gov/show/NCT01704144

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