Status:
UNKNOWN
Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra
Lead Sponsor:
Harriet Shezi Children's Clinic
Conditions:
Children With Confirmed HIV Infection
Receiving ART Regimen Containing 2 NRTIs + LPV/RTV at Standard Dose
Eligibility:
All Genders
5-18 years
Phase:
PHASE1
Brief Summary
Open label pharmacokinetic RBT dose-finding study in young (≤ 5 year old) HIV-infected children receiving a LPV/RTV-based ART regimen and who have a recent history of completing TB treatment.
Detailed Description
BACKGROUND AND RATIONALE The HIV and TB epidemics disproportionately affect sub-Saharan Africa, and have had a catastrophic impact in the region. The synergy between these pathogens has resulted in dr...
Eligibility Criteria
Inclusion
- SELECTION AND ENROLLMENT OF SUBJECTS
- Inclusion Criteria:
- Children with confirmed HIV infection. Confirmation can be by two rapid tests (children age \> 18 months) or virologic test (children \< 18 months), and detectable viral load prior to starting ARVs.
- Age ≤ 5 years old - rationale: changes in body composition and maturity of metabolizing enzymes and organs result in age-related differences in drug clearance, especially between children ≤ 5 years and children \> 5 years of age.
- Receiving an ART regimen containing 2 NRTIs + LPV/RTV at standard dose
- Successfully completed TB treatment in the past 2 to 6 weeks. Successful completion of treatment will be defined as children with good clinical response (resolution of TB symptoms) to treatment.
- Rationale:
- RBT has not yet been approved for treatment of TB in children. Participating children can therefore not be in need treatment for TB as this may lead to substandard treatment.
- RBT monotherapy in the presence of Mycobacterium tuberculosis can lead to the development of resistance. Excluding active TB is difficult in children, especially those that are HIV co-infected. Children who have just successfully completed a treatment for TB can be assumed to be free of Mycobacterium tuberculosis.
- A minimum of two weeks is needed between RIF and RBT administration to ensure wash-out of any enzyme inducing effects of RIF.
- Exclusion Criteria
- History of symptomatic clinical hepatitis during TB treatment
- Abnormal liver function defined as ALT \> 2.5 times the normal upper limit (corresponding to the US National Institute of Health Division of AIDS scale grade 2)
- Abnormal bilirubin defined as \> 1.5 UNL (≥ DAIDS grade 2)
- Abnormal serum creatinine defined as \>1.1 x ULN
- Anemia defined as hemoglobin \< 8gm/dL
- Neutropenia defined as \< 1.0 x 109/L(corresponding to grade 2)
- Abnormal platelets defined as \<125 x 1012/L
- Pre-existing eye conditions
- Any condition that the clinician feels would predispose the child to toxicity
- Children required to take any drug known or predicted to interact with rifabutin (see appendix)
- Children who do not meet inclusion criteria and/or whose parents refuse consent.
Exclusion
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01259219
Start Date
November 1 2010
End Date
June 1 2012
Last Update
December 14 2010
Active Locations (3)
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1
Harriet Shezi Children's Clinic, Chris Hani Baragwanath Hospital, WHI, University of the Witwatersrand
Johannesburg, Gauteng, South Africa, 1864
2
Harriet Shezi Children's Clinic, Chris Hani Baragwanath Hospital, WHI, University of the Witwatersrand
Johannesburg, Gauteng, South Africa, 1864
3
Harriet Shezi Children's Clinic
Johannesburg, Gauteng, South Africa