The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-Naive HIV-1 Infected Patients - Tabular View

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Tracking Information

First Received Date ^†

November 9, 2006

Last Updated Date

April 21, 2009

Start Date ^†

March 2004

Current 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 ]

Original Primary Outcome Measures ^†

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

Change History

Complete list of historical versions of study NCT00400738 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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®

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.

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Pharmacokinetics/Dynamics Study

Condition ^†

HIV Infections

Intervention ^†

Drug: Saquinavir, lopinavir, ritonavir

Study Arms / Comparison Groups

Experimental: different dose per arm

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].

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

December 2006

Primary Completion Date

December 2006 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Thailand

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00400738

Responsible Party

Kiat Ruxrungtham, HIV-NAT

Secondary IDs ^††

Study Sponsor ^†

The HIV Netherlands Australia Thailand Research Collaboration

Collaborators ^††

Hoffmann-La Roche
International Antiviral Therapy Evaluation Center
The National Centre in HIV Epidemiology and Clinical Research

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

Information Provided By

The HIV Netherlands Australia Thailand Research Collaboration

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.