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

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ClinicalTrials.gov Identifier: NCT00411957
Recruitment Status : Completed
First Posted : December 15, 2006
Last Update Posted : June 7, 2010
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration

Study Description
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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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Atazanavir Phase 1 Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

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

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. The pharmacokinetic and pharmacodynamic between these patients and data from Thai cohort treated with ATV/RTV 300/100 mg OD [ Time Frame: 4 weeks ]
  2. short term safety, tolerability and efficacy data in these PK participating patients [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Publications of Results:

Responsible Party: Kiat Ruxrungtham, HIV-NAT
ClinicalTrials.gov Identifier: NCT00411957     History of Changes
Other Study ID Numbers: HIV-NAT 073
First Posted: December 15, 2006    Key Record Dates
Last Update Posted: June 7, 2010
Last Verified: June 2010

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
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ritonavir
Atazanavir Sulfate
 HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors