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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Saquinavir, lopinavir, ritonavir
Sponsored by
The HIV Netherlands Australia Thailand Research Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV-1 infection, pharmacokinetics, protease inhibitor, double boosted protease inhibitors, PIs, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The HIV Netherlands Australia Thailand Research Collaboration

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

different dose per arm

different dose per arm

different dose per arm

different dose per arm

Outcomes

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

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

Full Information

First Posted
November 9, 2006
Last Updated
April 3, 2012
Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Roche Pharma AG, International Antiviral Therapy Evaluation Center, Kirby Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00400738
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®
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The HIV Netherlands Australia Thailand Research Collaboration
Collaborators
Roche Pharma AG, International Antiviral Therapy Evaluation Center, Kirby Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1 infection, pharmacokinetics, protease inhibitor, double boosted protease inhibitors, PIs, Treatment Naive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
different dose per arm
Arm Title
2
Arm Type
Experimental
Arm Description
different dose per arm
Arm Title
3
Arm Type
Experimental
Arm Description
different dose per arm
Arm Title
4
Arm Type
Experimental
Arm Description
different dose per arm
Intervention Type
Drug
Intervention Name(s)
Saquinavir, lopinavir, ritonavir
Intervention Description
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 Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiat Ruxrunghtam, MD, PhD
Organizational Affiliation
The HIV Netherlands Australia Thailand Research Collaboration
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joep Lange, MD, PhD
Organizational Affiliation
International Antiviral Therapy Evaluation Center (IATEC), Center for Poverty-related Communicable Diseases, Department of Internal Medicine, Academic Medical Center (AMC), University of Amsterdam (UVA)
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Praphan Phanuphak, MD, PhD
Organizational Affiliation
The HIV Netherlands Australia Thailand Research Collaboration
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Burger, PharmD, PhD
Organizational Affiliation
Radboud University Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Cooper, MD, PhD
Organizational Affiliation
National Center in HIV Epidemiology and Clinical Research
Official's Role
Study Chair
Facility Information:
Facility Name
The HIV Netherlands Australia Thailand Research Collaboration
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
18285316
Citation
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. doi: 10.1093/jac/dkn050. Epub 2008 Feb 18. Erratum In: J Antimicrob Chemother. 2008 Oct;62(4):852. Avihingson, Anchalee [corrected to Avihingsanon, Anchalee].
Results Reference
background
PubMed Identifier
27516476
Citation
Maughan RT, Feeney ER, Capel E, Capeau J, Domingo P, Giralt M, Lange JM, Phanuphak P, Cooper DA, Reiss P, Mallon PW; HIVNAT-019 Study Group. Improved adipose tissue function with initiation of protease inhibitor-only ART. J Antimicrob Chemother. 2016 Nov;71(11):3212-3221. doi: 10.1093/jac/dkw301. Epub 2016 Aug 11.
Results Reference
derived

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

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