Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra (RBT)
Recruitment status was Recruiting
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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.
Condition | Intervention | Phase |
---|---|---|
Children With Confirmed HIV Infection Receiving ART Regimen Containing 2 NRTIs + LPV/RTV at Standard Dose Successfully Completed TB Treatment in the Past 2 to 6 Weeks of Enrollment |
Drug: Mycobutin |
Phase 1 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra |
- To assess dosing, pharmacokinetic profile, and safety of rifabutin when given concomitantly with LPV/RTV for 14 days in HIV-infected children age < 5 years. [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]
- We hypothesize that a clinically significant drug interaction exists between rifabutin & /lopinavir/ritonavir in young children (age < 5 years) such that rifabutin dosing for concomitant administration of RBT & LPV/RTV needs to be developed [ Time Frame: 6-24 months ] [ Designated as safety issue: Yes ]
Estimated Enrollment: | 40 |
Study Start Date: | November 2010 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: Rifabutin (Mycobutin)
Rifabutin is a red-violet powder souble in chloroform and methanol, sparingly souluble in ethanol, and very slightly soluble in water. Mycobutin capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. Mycobutin capsules for oral administered contain 150mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose magenesium stearate, red iron oxide3, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink.
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Drug: Mycobutin
Indication and Usage: Mycobutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV Infection. Dosage and Directions for use: Mycobutin cab be administred as a single daily dose, independent of meals. In all cases Mycobutin is to be administred in combination regimens. Identification: Red-brown, self locking, hard gelatin capsule, size 0, containing a violet powder. |
Show Detailed Description
Ages Eligible for Study: | 5 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
Contact: Shobna Sawry, MSc (Med) Epi & Bio BScHonours | 27119339629 | shobnas@witsecho.org.za |
Contact: Annelies Van Rie, MD & PhD | +1919 9661420 | vanrie@email.unc.edu |
South Africa | |
Harriet Shezi Children's Clinic, Chris Hani Baragwanath Hospital, WHI, University of the Witwatersrand | Recruiting |
Johannesburg, Gauteng, South Africa, 1864 | |
Contact: Hermien Gous, PharmD 27119388189 hermieng@witsecho.org.za | |
Harriet Shezi Children's Clinic, Chris Hani Baragwanath Hospital, WHI, University of the Witwatersrand | Recruiting |
Johannesburg, Gauteng, South Africa, 1864 | |
Principal Investigator: Henry (Harry) AJ Moultrie, MD | |
Harriet Shezi Children's Clinic | Recruiting |
Johannesburg, Gauteng, South Africa | |
Contact: Sonwabo Lindani, RN 27 11 933 9392 sonwabol@witsecho.org.za | |
Contact: Merleesa Govender 27 11 933 9630 merleesag@witsecho.org.za |
Principal Investigator: | Henry (Harry) JA Moultrie, MD, Master's in epi | Harriet Shezi Children's Clinic, Chris Hani Baragwanth Hospital, WHI, University of the Witwatersrand |
No publications provided
Responsible Party: | Dr Harry Moultrie, Harriet Shezi Children's Clinic, Chris Hani Baragwanath Hospital, WHI, University of the Witwatersrand |
ClinicalTrials.gov Identifier: | NCT01259219 History of Changes |
Other Study ID Numbers: | Rifabutin (RBT) |
Study First Received: | December 13, 2010 |
Last Updated: | December 13, 2010 |
Health Authority: | South Africa: Human Research Ethics Committee South Africa: Medicines Control Council |
Keywords provided by Harriet Shezi Children's Clinic:
HIV Completion of TB treamtment |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Rifabutin Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antibiotics, Antitubercular Antitubercular Agents |
ClinicalTrials.gov processed this record on March 03, 2013