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

The HIV Netherlands Australia Thailand Research Collaboration48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections

Interventions

Saquinavir, lopinavir, ritonavirDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. written informed consent 2. ARV-naïve 3. HIV-1 infected Thai male or female \> 18 years old 4. Documented positive test for HIV-1 infection Exclusion Criteria: 1. Inability to understand the nature and extent of the study and the procedures required. 2. Pregnancy or lactating 3. Active opportunistic infection 4. ALT/ AST more than 2x upper limit 5. creatinine more than 1.5 time the upper limit 6. Smoke cigarettes more than 10 cigarettes a day. 7. Drink alcohol more than 2 units a day 8. Relevant history or current condition, illness that might interfere with drug absorption, distribution, metabolism or excretion. 9. Use of concomitant medication that may interfere with the pharmacokinetics of lopinavir/ritonavir or saquinavir

Locations (1)

The HIV Netherlands Australia Thailand Research Collaboration

Bangkok, Thailand

Outcomes

Primary Outcomes

study the pharmacokinetics of low dose and standard dose lopinavir/ritonavir and saquinavir HGC in ARV naive HIV-1 infected Thai patients

Time frame: 1 year

Secondary Outcomes

To describe 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

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.