Trial | NCT00400738  Report issue

Title

The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients
Pharmacokinetics of and Rate of HIV-1 RNA Decline in ARV-naive HIV-1 Infected Patients Treated With Low- or Standard-dose Saquinavir HGC (Invirase®) and Lopinavir/Ritonavir (Kaletra®

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    48
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 explore this idea.
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 remaining classes are spared. This leaves the option to use these classes in the future, for instance in cases of drug resistance. Laboratory data have shown that the combination of saquinavir with lopinavir and ritonavir may a good regimen. This study will explore this idea.
Study Started
Mar 31
2004
Primary Completion
Dec 31
2006
Study Completion
Dec 31
2006
Last Update
Apr 05
2012
Estimate

Drug Saquinavir, lopinavir, ritonavir

arm 1 = LPV/RTV 400/100 mg BID + SQV 1000 mg BID arm 2 = LPV/RTV 400/100 mg BID + SQV 600 mg BID arm 3 = LPV/RTV 266/66 mg BID + SQV 1000 mg BID arm 4 = LPV/RTV 266/66 mg BID + SQV 600 mg BID

1 Experimental

different dose per arm

2 Experimental

different dose per arm

3 Experimental

different dose per arm

4 Experimental

different dose per arm

Criteria 

Inclusion Criteria:

written informed consent
ARV-naïve
HIV-1 infected Thai male or female > 18 years old
Documented positive test for HIV-1 infection

Exclusion Criteria:

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
No Results Posted