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Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra (RBT)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Harriet Shezi Children's Clinic.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Harriet Shezi Children's Clinic
Information provided by:
Harriet Shezi Children's Clinic
ClinicalTrials.gov Identifier:
NCT01259219
First received: December 13, 2010
Last updated: NA
Last verified: December 2010
History: No changes posted
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Purpose
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 Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra |
Resource links provided by NLM:
Further study details as provided by Harriet Shezi Children's Clinic:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| 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.
|
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
Eligibility| Ages Eligible for Study: | 5 Years to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259219
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259219
Contacts
| 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 |
Locations
| 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 | |
Sponsors and Collaborators
Harriet Shezi Children's Clinic
Investigators
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
Keywords provided by Harriet Shezi Children's Clinic:
|
HIV Completion of TB treamtment |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Immunologic Deficiency Syndromes Immune System Diseases Rifabutin Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antitubercular Antitubercular Agents |
ClinicalTrials.gov processed this record on August 23, 2017