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

This study has been completed.
Sponsor:
Collaborators:
Roche Pharma AG
International Antiviral Therapy Evaluation Center
Kirby Institute
Information provided by:
The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:
NCT00400738
First received: November 9, 2006
Last updated: April 3, 2012
Last verified: April 2012

November 9, 2006
April 3, 2012
March 2004
December 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
  • study the pharmacokinrtics of low dose and standard dose lopinavir/ritonavir and saquinavirHGC in ARV naive HIV-1 infected Thai patients
  • To study first and second-phase viral decay after initiating ART with low-dose or standard-dose lopinavir/ritonavir and saquinavirHGC
Complete list of historical versions of study NCT00400738 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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
Not Provided
Not Provided
 
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®

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
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
  • Experimental: 1
    different dose per arm
    Intervention: Drug: Saquinavir, lopinavir, ritonavir
  • Experimental: 2
    different dose per arm
    Intervention: Drug: Saquinavir, lopinavir, ritonavir
  • Experimental: 3
    different dose per arm
    Intervention: Drug: Saquinavir, lopinavir, ritonavir
  • Experimental: 4
    different dose per arm
    Intervention: Drug: Saquinavir, lopinavir, ritonavir
van der Lugt J, Autar RS, Ubolyam S, Garcia EF, Sankote J, Avihingsanon A, Chuenyam T, Cooper DA, Lange J, Phanuphak P, Wit F, Ruxrungtham K, Burger D; HIV-NAT 019 Study Team. Pharmacokinetics and short-term efficacy of a double-boosted protease inhibitor regimen in treatment-naive HIV-1-infected adults. J Antimicrob Chemother. 2008 May;61(5):1145-53. Epub 2008 Feb 18. Erratum in: J Antimicrob Chemother. 2008 Oct;62(4):852. Avihingson, Anchalee [corrected to Avihingsanon, Anchalee].

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00400738
HIV-NAT 019
No
Kiat Ruxrungtham, HIV-NAT
The HIV Netherlands Australia Thailand Research Collaboration
  • Roche Pharma AG
  • International Antiviral Therapy Evaluation Center
  • Kirby Institute
Principal Investigator: Kiat Ruxrunghtam, MD, PhD The HIV Netherlands Australia Thailand Research Collaboration
Study Chair: Joep Lange, MD, PhD International Antiviral Therapy Evaluation Center (IATEC), Center for Poverty-related Communicable Diseases, Department of Internal Medicine, Academic Medical Center (AMC), University of Amsterdam (UVA)
Study Chair: Praphan Phanuphak, MD, PhD The HIV Netherlands Australia Thailand Research Collaboration
Study Chair: David Burger, PharmD, PhD Radboud University
Study Chair: David Cooper, MD, PhD National Center in HIV Epidemiology and Clinical Research
The HIV Netherlands Australia Thailand Research Collaboration
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP