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®

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00400738

Enrollment

Registered

2006-11-17

Start date

2004-03-31

Completion date

2006-12-31

Last updated

2012-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

HIV-1 infection, pharmacokinetics, protease inhibitor, double boosted protease inhibitors, PIs, Treatment Naive

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 explore this idea.

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 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.

Interventions

DRUGSaquinavir, 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	1 year

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026