Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Atazanavir
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring atazanavir/ritonavir, pharmacokinetic of ATV/r200/100 OD+2NRTIs
Eligibility Criteria
Inclusion Criteria:
- Written informed consent
- Adults HIV patients currently using ATV/RTV 300/100 mg OD plus 2 NRTIs
- HIV RNA < 50 copies/ml
Exclusion Criteria:
- 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
Sites / Locations
- HIV-NAT, Thai Red Cross AIDS Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
ATV/r 300/100 mg
ATV/r 200/100 mg OD
Outcomes
Primary Outcome Measures
the pharmacokinetics of atazanavir/ritonavir (ATV/RTV) 200/100 mg once daily in a sample of 22 patients experiencing virological success
Secondary Outcome Measures
The pharmacokinetic and pharmacodynamic between these patients and data from Thai cohort treated with ATV/RTV 300/100 mg OD
short term safety, tolerability and efficacy data in these PK participating patients
Full Information
NCT ID
NCT00411957
First Posted
December 13, 2006
Last Updated
July 15, 2020
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT00411957
Brief Title
Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients
Official Title
The Pharmacokinetics of Atazanavir / Ritonavir 200/100 OD Versus 300/100 mg OD in Combination With 2 NRTIs in HIV Pre-treated Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 been explored in a Thai population. We postulate that ATV levels, as with other PIs, are higher in Thai people. Therefore, the level of ATV in ATV/RTV 300/100 OD may be higher than the acceptable range and could be associated with ATV related toxicity.
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 studies evaluating pharmacokinetic and long term efficacy and safety of atazanavir/ritonavir once daily dose in combination of NRTIs in HIV-1 pretreated patients. We believe that the PK parameters of ATV/RTV given at 200/100mg daily in Thai patients will be equivalent to the ATV/RTV 300/100mg once daily dosing in Caucasian patients when combined with 2NRTIs, and that the once daily regimen will have better safety, tolerability profile, and cost saving while maintaining good CD4 and VL outcome. If, the pharmacokinetic profile of ATV/RTV 200/100 mg OD + 2NRTIs is in acceptable range or comparable with standard dose of ATV/RTV 300/100 mg OD, long term efficacy will be explored later.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
atazanavir/ritonavir, pharmacokinetic of ATV/r200/100 OD+2NRTIs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
ATV/r 300/100 mg
Arm Title
2
Arm Type
Active Comparator
Arm Description
ATV/r 200/100 mg OD
Intervention Type
Drug
Intervention Name(s)
Atazanavir
Intervention Description
ATV/r 300/100mg OD vs ATV/r 200/100 mg OD
Primary Outcome Measure Information:
Title
the pharmacokinetics of atazanavir/ritonavir (ATV/RTV) 200/100 mg once daily in a sample of 22 patients experiencing virological success
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The pharmacokinetic and pharmacodynamic between these patients and data from Thai cohort treated with ATV/RTV 300/100 mg OD
Time Frame
4 weeks
Title
short term safety, tolerability and efficacy data in these PK participating patients
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent
Adults HIV patients currently using ATV/RTV 300/100 mg OD plus 2 NRTIs
HIV RNA < 50 copies/ml
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiat Ruxrungtham, MD
Organizational Affiliation
HIV-NAT Thai Red Cross AIDS Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
HIV-NAT, Thai Red Cross AIDS Research Center
City
Bangkok
ZIP/Postal Code
10300
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
19118378
Citation
Avihingsanon A, van der Lugt J, Kerr SJ, Gorowara M, Chanmano S, Ohata P, Lange J, Cooper DA, Phanuphak P, Burger DM, Ruxrungtham K. A low dose of ritonavir-boosted atazanavir provides adequate pharmacokinetic parameters in HIV-1-infected Thai adults. Clin Pharmacol Ther. 2009 Apr;85(4):402-8. doi: 10.1038/clpt.2008.244. Epub 2008 Dec 31.
Results Reference
result
Links:
URL
http://www.hivnat.org
Description
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)
Learn more about this trial
Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients
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