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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411957
• Other study ID #: HIV-NAT 073
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2007
• Est. completion date: January 2008

Study information

• Verified date: July 2020
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Atazanavir
ATV/r 300/100mg OD vs ATV/r 200/100 mg OD

Locations

Country	Name	City	State
Thailand	HIV-NAT, Thai Red Cross AIDS Research Center	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Bristol-Myers Squibb

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. Cli — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the pharmacokinetics of atazanavir/ritonavir (ATV/RTV) 200/100 mg once daily in a sample of 22 patients experiencing virological success		1 year
Secondary	The pharmacokinetic and pharmacodynamic between these patients and data from Thai cohort treated with ATV/RTV 300/100 mg OD		4 weeks
Secondary	short term safety, tolerability and efficacy data in these PK participating patients		4 weeks

External Links

•   The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)