Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00411957
First received: December 13, 2006
Last updated: June 4, 2010
Last verified: June 2010

December 13, 2006
June 4, 2010
January 2007
January 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
the pharmacokinetics of atazanavir/ritonavir (ATV/RTV) 200/100 mg once daily in a sample of 22 patients experiencing virological success
Complete list of historical versions of study NCT00411957 on ClinicalTrials.gov Archive Site
  • The pharmacokinetic and pharmacodynamic between these patients and data from Thai cohort treated with ATV/RTV 300/100 mg OD [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • short term safety, tolerability and efficacy data in these PK participating patients [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • 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
Not Provided
Not Provided
 
Pharmacokinetic Study of 2 Doses of ATV/r OD + 2 NRTIs in Thai HIV-1 Infected Patients
The Pharmacokinetics of Atazanavir / Ritonavir 200/100 OD Versus 300/100 mg OD in Combination With 2 NRTIs in HIV Pre-treated Patients

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: Atazanavir
ATV/r 300/100mg OD vs ATV/r 200/100 mg OD
  • Active Comparator: 1
    ATV/r 300/100 mg
    Intervention: Drug: Atazanavir
  • Active Comparator: 2
    ATV/r 200/100 mg OD
    Intervention: Drug: Atazanavir
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. Epub 2008 Dec 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
January 2008
January 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00411957
HIV-NAT 073
Yes
Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
Bristol-Myers Squibb
Principal Investigator: Kiat Ruxrungtham, MD HIV-NAT Thai Red Cross AIDS Research Center
The HIV Netherlands Australia Thailand Research Collaboration
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP