Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra (RBT)
Recruitment status was: Recruiting
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
|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 ]
|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)|
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.
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.
Red-brown, self locking, hard gelatin capsule, size 0, containing a violet powder.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259219
|Harriet Shezi Children's Clinic, Chris Hani Baragwanath Hospital, WHI, University of the Witwatersrand|
|Johannesburg, Gauteng, South Africa, 1864|
|Harriet Shezi Children's Clinic|
|Johannesburg, Gauteng, South Africa|
|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|