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

NCT00400738 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-04-05

No results posted yet for this study

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.

Conditions

  • HIV Infections

Interventions

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • International Antiviral Therapy Evaluation Center

    collaborator OTHER

  • Kirby Institute

    collaborator OTHER_GOV

  • The HIV Netherlands Australia Thailand Research Collaboration

    lead OTHER

Principal Investigators

  • Kiat Ruxrunghtam, MD, PhD · The HIV Netherlands Australia Thailand Research Collaboration

  • 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)

  • Praphan Phanuphak, MD, PhD · The HIV Netherlands Australia Thailand Research Collaboration

  • David Burger, PharmD, PhD · Radboud University Medical Center

  • David Cooper, MD, PhD · National Center in HIV Epidemiology and Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2006-12-31
Completion
2006-12-31

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00400738 on ClinicalTrials.gov