Status:
COMPLETED
The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Collaborating Sponsors:
Roche Pharma AG
International Antiviral Therapy Evaluation Center
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Treatment with only protease inhibitors might benefit HIV patients. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explo...
Detailed Description
Treatment with only protease inhibitors might benefit HIV patients, who experience problems with the other antiretrovirals drugs classes. Another reason to only use protease inhibitors is that the rem...
Eligibility Criteria
Inclusion
- written informed consent
- ARV-naïve
- HIV-1 infected Thai male or female \> 18 years old
- Documented positive test for HIV-1 infection
Exclusion
- Inability to understand the nature and extent of the study and the procedures required.
- Pregnancy or lactating
- Active opportunistic infection
- ALT/ AST more than 2x upper limit
- creatinine more than 1.5 time the upper limit
- Smoke cigarettes more than 10 cigarettes a day.
- Drink alcohol more than 2 units a day
- 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 lopinavir/ritonavir or saquinavir
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00400738
Start Date
March 1 2004
End Date
December 1 2006
Last Update
April 5 2012
Active Locations (1)
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1
The HIV Netherlands Australia Thailand Research Collaboration
Bangkok, Thailand, 10330