Status:
COMPLETED
Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief Summary
Several studies from HIV-NAT have demonstrated high nevirapine, indinavir, saquinavir and lopinavir/r levels when compared to Caucasian patients. Until now, the pharmacokinetics of atazanavir have not...
Detailed Description
We are interested in once daily ATV/RTV 200/100 mg OD because of the convenience, reduction in ATV doses which may improve adherence while reducing toxicity and cost. There are limited prospective stu...
Eligibility Criteria
Inclusion
- Written informed consent
- Adults HIV patients currently using ATV/RTV 300/100 mg OD plus 2 NRTIs
- HIV RNA \< 50 copies/ml
Exclusion
- Inability to understand the nature and extent of the study and the procedures required.
- ALT/ AST more than 5x upper limit
- Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion.
- Use of concomitant medication that may interfere with the pharmacokinetics of atazanavir, and ritonavir
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
- Active drug abuse or heavy alcoholic drinking
- History of sensitivity/idiosyncrasy to the drug or chemically related compounds which may be employed in the study.
- Active drug abuse or heavy alcoholic drinking
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00411957
Start Date
January 1 2007
End Date
January 1 2008
Last Update
July 17 2020
Active Locations (1)
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1
HIV-NAT, Thai Red Cross AIDS Research Center
Bangkok, Thailand, 10300