The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients
NCT ID: NCT00400738
Last Updated: 2012-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2004-03-31
2006-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
different dose per arm
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
2
different dose per arm
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
3
different dose per arm
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
4
different dose per arm
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. ARV-naïve
3. HIV-1 infected Thai male or female \> 18 years old
4. Documented positive test for HIV-1 infection
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
International Antiviral Therapy Evaluation Center
OTHER
Kirby Institute
OTHER_GOV
The HIV Netherlands Australia Thailand Research Collaboration
OTHER
Responsible Party
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HIV-NAT
Principal Investigators
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Kiat Ruxrunghtam, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The HIV Netherlands Australia Thailand Research Collaboration
Joep Lange, MD, PhD
Role: STUDY_CHAIR
International Antiviral Therapy Evaluation Center (IATEC), Center for Poverty-related Communicable Diseases, Department of Internal Medicine, Academic Medical Center (AMC), University of Amsterdam (UVA)
Praphan Phanuphak, MD, PhD
Role: STUDY_CHAIR
The HIV Netherlands Australia Thailand Research Collaboration
David Burger, PharmD, PhD
Role: STUDY_CHAIR
Radboud University Medical Center
David Cooper, MD, PhD
Role: STUDY_CHAIR
National Center in HIV Epidemiology and Clinical Research
Locations
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The HIV Netherlands Australia Thailand Research Collaboration
Bangkok, , Thailand
Countries
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References
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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.
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.
Other Identifiers
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HIV-NAT 019
Identifier Type: -
Identifier Source: org_study_id
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