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
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Saquinavir, lopinavir, ritonavir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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®

Resource links provided by NLM:


Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: March 2004
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
different dose per arm
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: 2
different dose per arm
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: 3
different dose per arm
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: 4
different dose per arm
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400738

Locations
Thailand
The HIV Netherlands Australia Thailand Research Collaboration
Bangkok, Thailand, 10330
Sponsors and Collaborators
The HIV Netherlands Australia Thailand Research Collaboration
Roche Pharma AG
International Antiviral Therapy Evaluation Center
Kirby Institute
Investigators
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
  More Information

Publications:
Responsible Party: Kiat Ruxrungtham, HIV-NAT
ClinicalTrials.gov Identifier: NCT00400738     History of Changes
Other Study ID Numbers: HIV-NAT 019
Study First Received: November 9, 2006
Last Updated: April 3, 2012
Health Authority: Thailand: Food and Drug Administration

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:
HIV-1 infection
pharmacokinetics
protease inhibitor
double boosted protease inhibitors
PIs
Treatment Naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Protease Inhibitors
Saquinavir
Ritonavir
Lopinavir
HIV Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014