Rifampin and Efavirenz Interactions in Older Children
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ClinicalTrials.gov Identifier: NCT01704144 |
Recruitment Status
: Unknown
Verified September 2012 by The Miriam Hospital.
Recruitment status was: Recruiting
First Posted
: October 11, 2012
Last Update Posted
: October 17, 2012
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Condition or disease |
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HIV Tuberculosis |

Study Type : | Observational |
Estimated Enrollment : | 160 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Effect of Rifampin-containing Anti-TB Treatment on Efavirenz Pharmacokinetics in HIV/TB Co-infected Children Aged 3 - 14 Years |
Study Start Date : | October 2012 |
Estimated Primary Completion Date : | May 2017 |
Estimated Study Completion Date : | May 2017 |
- Area under time curve from time 0-24 hours(AUC0-24h) of efavirenz [ Time Frame: At week of 4 of HIV therapy ]Compare efavirenz AUC0-24h between HIV-infected children without TB and those with TB on rifampin-containing anti-TB therapy in co-infected patients
- 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 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 efavirenz 24-hour post-dose concentration (C24h) < 1000 ng/mL [ Time Frame: At week 4 of therapy ]Relationship between clinical factors (weight, gender, nutritional status) as well as genetic factors (CYP2B6 516G>T, as well as CYP3A4, ABCB1, CAR and PXR polymorphisms) and efavirenz AUC0-24h and efavirenz C24h will be investigated
- Number of children who discontinue efavirenz therapy due to drug side effects [ Time Frame: Up to week 24 of HIV therapy ]Relationship between clinical factors (weight, gender, nutritional status) as well as genetic factors (CYP2B6 polymorphisms) and treatment modification due to drug side effects in the combined study population
- Trough concentration (C24h) of efavirenz [ Time Frame: At week 4 of therapy ]Compare efavirenz C24h 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
- AUC, Cmax and clearance of efavirenz on and off rifampin-containing anti-Tb therapy in HIV/TB co-infected patients [ Time Frame: at week 24 of therapy ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 3 Years to 14 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
- Aged 3 months to 14 years old
- 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:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704144
Contact: Awewura Kwara, MD, MPH&TM | 4017932463 | akwara@lifespan.org | |
Contact: Sampson Antwi, MBChB | +233265812061 | antwisampson10@yahoo.com |
Ghana | |
Komfo Anokye Teaching Hospital | Recruiting |
Kumasi, Ghana | |
Contact: Sampson Antwi, MBchB +233265812061 antwisampson10@yahoo.com | |
Contact: Anthony Enimil, MBChB +233208164433 tenimil@live.com |
Principal Investigator: | Awewura Kwara, MD, MPH&TM | The Miriam Hospital |
Responsible Party: | The Miriam Hospital |
ClinicalTrials.gov Identifier: | NCT01704144 History of Changes |
Other Study ID Numbers: |
PK-PTBHIV03 R01HD071779 ( U.S. NIH Grant/Contract ) |
First Posted: | October 11, 2012 Key Record Dates |
Last Update Posted: | October 17, 2012 |
Last Verified: | September 2012 |
Keywords provided by The Miriam Hospital:
Efavirenz rifampin Pharmacokinetics |
Drug-drug interactions Drug-gene interactions Children |
Additional relevant MeSH terms:
Tuberculosis Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Efavirenz Rifampin Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |
Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers Antibiotics, Antitubercular Antitubercular Agents Anti-Bacterial Agents Leprostatic Agents Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers Cytochrome P-450 CYP2C9 Inducers |