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

NCT ID: NCT00400738

Last Updated: 2012-04-05

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-12-31

Brief Summary

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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

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

different dose per arm

Group Type EXPERIMENTAL

Saquinavir, lopinavir, ritonavir

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Saquinavir, lopinavir, ritonavir

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Saquinavir, lopinavir, ritonavir

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Saquinavir, lopinavir, ritonavir

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

International Antiviral Therapy Evaluation Center

OTHER

Sponsor Role collaborator

Kirby Institute

OTHER_GOV

Sponsor Role collaborator

The HIV Netherlands Australia Thailand Research Collaboration

OTHER

Sponsor Role lead

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

Site Status

Countries

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Thailand

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.

Reference Type BACKGROUND
PMID: 18285316 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27516476 (View on PubMed)

Other Identifiers

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HIV-NAT 019

Identifier Type: -

Identifier Source: org_study_id

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