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OpenTrials
Completed

NCT Number: NCT00400738

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The HIV Netherlands Australia Thailand Research Collaboration

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saquinavir, lopinavir, ritonavir

Drug

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

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • International Antiviral Therapy Evaluation Center
  • Kirby Institute
  • Roche Pharma AG

Registry information

Official study 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®

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Nov 17, 2006
Registry last updated
Apr 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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