The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-Naive HIV-1 Infected Patients

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.

Official Title

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)

Conditions

• HIV Infections

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study

Further Details

• Primary Outcome Measures: pharmacokinrtics of low dose and standard dose lopinavir/ritonavir and saquinavirHGC in ARV naive HIV-1 infected patients; first and second-phase viral decay after initiating ART with low-dose or standard-dose lopinavir/ritonavir and saquinavirHGC.
• Secondary Outcome Measures: short-term tolerability, toxicity and efficacy of combinations of low-dose and standard dose lopinavir/ritonavir and saquinavirHGC given to the patients in this trial

Study Start

March 2004; Study completion: May 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy or lactating
• Active opportunistic infection
• ALT/ AST more than 2x upper limit
• creatinine more than 1.5 time the upper limit
• creatinine more than 1.5 time the upper limit
• 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

Total Enrolment

48

Contact Details

Kiat Ruxrunghtam, MD, PhD, Principal Investigator, The HIV Netherlands Australia Thailand Research Collaboration

• The HIV Netherlands Australia Thailand Research Collaboration, Bangkok, 10330, Thailand