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Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects

This study has been completed.

Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00043953
  Purpose

The objectives of this study are to explore the metabolic toxicities associated with lopinavir/ritonavir (LPV/r) plus saquinavir mesylate (INV) versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the overall safety, tolerability and efficacy of LPV/r plus INV versus LPV/r plus Combivir in antiretroviral naïve subjects and to assess the pharmacokinetics of 400 mg INV taken twice a day (BID), 600 mg INV BID and 800 mg INV BID in combination with 400 mg lopinavir/100 mg ritonavir plus 150 mg lamivudine/300 mg zidovudine BID.


Condition Intervention Phase
HIV Infections
Drug: Lopinavir/ritonavir
Drug: Saquinavir mesylate
Drug: Lamivudine/zidovudine
Phase II

MedlinePlus related topics:   AIDS   

Drug Information available for:   Zidovudine    Lamivudine    Ritonavir    Lopinavir    Saquinavir    Saquinavir mesylate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase II Study of Lopinavir/Ritonavir in Combination With Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-Infected Subjects

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion of subjects with plasma HIV RNA level below 50 copies/mL [ Time Frame: 48 weeks ]

Enrollment:   30
Study Start Date:   August 2002

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Subject is naïve to antiretroviral treatment (subjects may not have more than 7 days of any antiretroviral treatment).
  • Subject is at least 18 years of age, inclusive.
  • If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:condoms, sponge, foams, jellies, diaphragm or intrauterine device(IUD), a vasectomized partner, total abstinence from sexual intercourse
  • If female, the results of a urine pregnancy test performed at screening (urine specimen obtained no earlier than 28 days prior to study drug administration) is negative.
  • Subject is not breast-feeding.
  • Vital signs, physical examination and laboratory results do not exhibit evidence of acute illness.
  • Subject has no significant history of cardiac, renal, neurologic, psychiatric, oncologic, endocrinologic, metabolic or hepatic disease that would in the opinion of the investigator adversely affect his/her participating in this study.
  • Subject does not require and agrees not to take any of the following medications for the duration of the study: midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, propafenone, flecainide, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), rifampin, lovastatin, simvastatin, and St. John's wort.
  • Subject agrees not to take any medication during the study, including over-the-counter medicine, alcohol or recreational drugs without the knowledge and permission of the principal investigator.
  • Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening.
  • Subject has a plasma HIV RNA level of greater than 400 copies/mL at screening.
  • Subject agrees to take all doses of the study drug from the bottles provided by the sponsor (rather than other containers, i.e., "pill box").
  • Subject has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed.

Exclusion Criteria:

  • Subject has a history of an allergic reaction or significant sensitivity to LPV/r, INV or Combivir.
  • Subject has a history of substance abuse or psychiatric illness that could preclude adherence with the protocol.
  • Screening laboratory analyses show any of the following abnormal laboratory results:

    • Hemoglobin ≤ 10.0 g/dL
    • Absolute neutrophil count ≤ 1000 cells/µL
    • Platelet count ≤ 50,000 per mL
    • ALT or AST ≥ 3.0 x Upper Limit of Normal (ULN)
    • Creatinine ≥ 1.5 x Upper Limit of Normal (ULN)
  • Subject has received any investigational drug within 30 days prior to study drug administration.
  • For any reason, subject is considered by the investigator to be an unsuitable candidate for the study.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043953

Locations
United States, California
Stephen Becker, MD    
      San Francisco,, California, United States, 94115
Harbor UCLA, Research & Education Institute    
      Torrance, California, United States, 90502
AHF Research    
      Los Angeles, California, United States, 90015
Pacific Horizon Medical Group    
      San Francisco, California, United States, 94115
AHF Research    
      Los Angeles, California, United States, 90015
United States, Massachusetts
Community Research Initiative of New England    
      Boston,, Massachusetts, United States, 02215
Community Research Initiative of New England    
      Springfield, Massachusetts, United States, 01107
United States, North Carolina
University of North Carolina at Chapel Hill    
      Chapel Hill,, North Carolina, United States, 27599
Duke University Medical Center    
      Durham, North Carolina, United States, 27710
The University of North Carolina at Chapel Hill    
      Chapel Hill, North Carolina, United States, 27599-7215
Duke University Medical Center    
      Durham, North Carolina, United States, 27710
Canada
University of Ottawa at the Ottawa Health Research Institute    
      Ottawa,, Canada, K1H 8L6
University of Ottawa Health Research Institute    
      Ottawa, Canada, K1H 8L6

Sponsors and Collaborators
Abbott

Investigators
Study Director:     Barbara A da Silva, M.D.     Associate Medical Director, Antiviral Global Project Team    
  More Information


Study ID Numbers:   M01-384
First Received:   August 15, 2002
Last Updated:   September 26, 2007
ClinicalTrials.gov Identifier:   NCT00043953
Health Authority:   United States: Food and Drug Administration

Keywords provided by Abbott:
treatment naive  

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
Lopinavir
Saquinavir
Ritonavir
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lamivudine
Zidovudine
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
HIV Protease Inhibitors
RNA Virus Infections
Anti-HIV Agents
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Reverse Transcriptase Inhibitors
Anti-Retroviral Agents
Therapeutic Uses
Lentivirus Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008




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