Rifampin and Nevirapine Interactions in Young Children
This study is currently recruiting participants.
Verified September 2012 by The Miriam Hospital
Sponsor:
The Miriam Hospital
Collaborator:
Information provided by (Responsible Party):
The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT01699633
First received: September 14, 2012
Last updated: October 11, 2012
Last verified: September 2012
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Purpose
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.
| Condition |
|---|
|
Tuberculosis HIV |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effect of Rifampin-containing Anti-TB Therapy on Nevirapine Plasma Pharmacokinetics in HIV/TB Co-infected Children < 3 Years Old |
Resource links provided by NLM:
Further study details as provided by The Miriam Hospital:
Primary Outcome Measures:
- Area under time curve (AUC) of nevirapine [ Time Frame: At week of 4 of HIV therapy ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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
Biospecimen Retention: Samples With DNA
EDTA Plasma Whole blood DNA
| Estimated Enrollment: | 58 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | May 2017 |
| Estimated Primary Completion Date: | May 2017 (Final data collection date for primary outcome measure) |
Show Detailed Description Eligibility| Ages Eligible for Study: | 3 Months to 35 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Children aged 3 to 35 months with HIV infection with or without TB
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699633
Contacts
| Contact: Awewura Kwara, MD, MPH&TM | 4017932463 | akwara@lifespan.org |
| Contact: Sampson Antwi, MBChB | +233265812061 | antwisampson@yahoo.com |
Locations
| Ghana | |
| Komfo Anokye Teaching Hospital | Recruiting |
| Kumasi, Ghana | |
| Contact: Sampson Antwi, MBChB +233265812061 antwisampson10@yahoo.com | |
| Contact: Anthony Enimil, MBChB +233208164433 tenimil@live.com | |
Sponsors and Collaborators
The Miriam Hospital
Investigators
| Principal Investigator: | Awewura Kwara, MD, MPH&TM | The Miriam Hospital |
More Information
No publications provided
| Responsible Party: | The Miriam Hospital |
| ClinicalTrials.gov Identifier: | NCT01699633 History of Changes |
| Other Study ID Numbers: | PK-TBHIV02, R01HD071779 |
| Study First Received: | September 14, 2012 |
| Last Updated: | October 11, 2012 |
| Health Authority: | Ghana: Committee on Human Research |
Keywords provided by The Miriam Hospital:
|
Drug-drug interactions Drug-gene interactions Nevirapine Rifampicin children |
Additional relevant MeSH terms:
|
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Rifampin Nevirapine Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Antitubercular Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Nucleic Acid Synthesis Inhibitors Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Reverse Transcriptase Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013