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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
History of Changes
  Purpose

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.


Condition Intervention Phase
HIV Infections
 Drug: Atazanavir
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: January 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ATV/r 300/100 mg
 Drug: Atazanavir
ATV/r 300/100mg OD vs ATV/r 200/100 mg OD
Active Comparator: 2
ATV/r 200/100 mg OD
 Drug: Atazanavir
ATV/r 300/100mg OD vs ATV/r 200/100 mg OD

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411957

Locations
Thailand
HIV-NAT, Thai Red Cross AIDS Research Center
Bangkok, Thailand, 10300
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Bristol-Myers Squibb
Investigators
Principal Investigator: Kiat Ruxrungtham, MD HIV-NAT Thai Red Cross AIDS Research Center
  More Information

Additional Information:
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Kiat Ruxrungtham, HIV-NAT
ClinicalTrials.gov Identifier: NCT00411957     History of Changes
Other Study ID Numbers: HIV-NAT 073
Study First Received: December 13, 2006
Last Updated: June 4, 2010
Health Authority: Thailand: Food and Drug Administration

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
atazanavir/ritonavir
pharmacokinetic of ATV/r200/100 OD+2NRTIs

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
 Atazanavir
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013