Status:
COMPLETED
A Safety Study to Evaluate the Antiviral Activity of Darunavir in Combination With Ritonavir in HIV 1 Infected Children
Lead Sponsor:
Tibotec Pharmaceuticals, Ireland
Collaborating Sponsors:
Tibotec Pharmaceutical Limited
Conditions:
Human Immunodeficiency Virus 1
Eligibility:
All Genders
3-6 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication), safety and antiviral activity to support dose recommendations by body weight of darunavir with low...
Detailed Description
This is an open-label (all people know the identity of the intervention), study to evaluate the pharmacokinetics, safety and antiviral activity. Approximately 24 HIV-1 infected children will be enroll...
Eligibility Criteria
Inclusion
- Participants with a documented HIV 1 infection (by any of the local standard diagnostic methods, such as HIV PCR-DNA, ELISA or western blot (WB) test for HIV antibodies, etc.)
- Body weight from 10 kg to less than 20 kg at screening
- Participants currently on stable ART (anti retroviral therapy) for at least 12 weeks, who need to change their ARV regimen because it is currently failing, with a viral load of greater than 1000 copies/mL
- Screening genotype resistance test results showing less than 3 DRV resistance-associated mutations
- Parents or legal representative willing and able to give consent
Exclusion
- Participants with presence of any currently active conditions included in the listing of WHO ( World Health Organisation) Clinical Stage 4 and participants with presence of a non-HIV encephalopathy
- Administration of any ARV (antiretroviral) or non-ARV investigational medication or investigational vaccine within 30 days prior to screening, except for those medications where dose recommendations for children are available
- Life expectancy less than 6 months, according to the judgment of the investigator
- Co-enrollment in other clinical and/or cohort trials without written permission of the Sponsor
- Participants with any active clinically significant disease (eg, tuberculosis \[TB\], cardiac dysfunction, pancreatitis, acute viral infections) or findings during screening of medical history or physical examination that, in the investigator's opinion, would compromise the subject's safety or outcome of the study
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00919854
Start Date
September 1 2009
End Date
February 1 2011
Last Update
April 23 2014
Active Locations (8)
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1
Buenos Aires, Argentina
2
Rio de Janeiro, Brazil
3
São Paulo, Brazil
4
Chennai, India