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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:
The HIV Netherlands Australia Thailand Research Collaboration
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
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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 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:
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 ]
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 ]
- short term safety, tolerability and efficacy data in these PK participating patients [ Time Frame: 4 weeks ]
| 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 (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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00411957
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:
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 |
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 |
ClinicalTrials.gov processed this record on August 16, 2017