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Dosing, Safety and Pharmacokinetic Profile of Rifabutin in Children Receiving Concomitant Treatment With Kaletra

NCT01259219 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-12-14

No results posted yet for this study

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.

Conditions

  • 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

Interventions

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.

Sponsors & Collaborators

  • Harriet Shezi Children's Clinic

    lead OTHER

Principal Investigators

  • Henry (Harry) JA Moultrie, MD, Master's in epi · Harriet Shezi Children's Clinic, Chris Hani Baragwanth Hospital, WHI, University of the Witwatersrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-06-30
Completion
2012-06-30

Countries

  • South Africa

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01259219 on ClinicalTrials.gov