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

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Saquinavir Saquinavir mesylate Ritonavir Lopinavir

U.S. FDA Resources

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:

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

Contacts and Locations

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:

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].

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
HIV Protease Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013