Status:
COMPLETED
Pharmacokinetics of Low Dose Ritonavir
Lead Sponsor:
The HIV Netherlands Australia Thailand Research Collaboration
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Compare the Pharmacokinetics of ritonavir and saquinavir(using either Saquinavir /Ritonavir 1500/100 mg or 1500/50 mg) Evaluate short term tolerability, safety and toxicity Evaluate if there is any re...
Detailed Description
This study will focus on the combination of Saquinavir (SQV) and RTV. Firstly, this is because SQV is widely used in Thailand and has shown to be an adequate first and second line antiretroviral agent...
Eligibility Criteria
Inclusion
- Age \> 18 years
- Documented positive test for HIV-1 infection
- HIV RNA viral load 50 \< copies for at least 3 months
- Written informed consent
- On a Saquinavir 1500 mg based HAART regimen for at least 3 months
Exclusion
- Pregnant or lactating
- Use of concomitant medication that may interfere with the pharmacokinetics of saquinavir/ritonavir
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00622206
Start Date
January 1 2008
End Date
August 1 2008
Last Update
April 5 2012
Active Locations (1)
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1
HIV-NAT
Bangkok, Bangkok, Thailand, 10330