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A Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00075231
Recruitment Status : Completed
First Posted : January 8, 2004
Last Update Posted : October 2, 2006
Information provided by:

Brief Summary:
The purpose of this study is to determine whether a simplified lopinavir-ritonavir based therapy will continue to keep the viral load to very low levels after initial treatment with a combination of Kaletra® (lopinavir/ritonavir) plus Combivir® (lamivudine/zidovudine).

Condition or disease Intervention/treatment Phase
HIV Infections Drug: Kaletra® (lopinavir/ritonavir) Drug: Combivir® (lamivudine, zidovudine) Drug: Sustiva® (efavirenz) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study Exploring a Simplified Kaletra® (Lopinavir/Ritonavir)-Based Therapy Versus a Sustiva® (Efavirenz)-Based Standard of Care in Previously Non-Treated HIV-Infected Subjects
Study Start Date : December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Primary Outcome Measures :
  1. Proportion of subjects with a plasma HIV RNA level below 50 copies/mL at Week 96.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Subject is at least 18 years of age.
  • Subject is confirmed HIV positive and in the investigator's opinion requires antiretroviral (ARV) therapy.
  • Subject is naïve to HIV ARV therapy or has received < 7 days total of any HIV ARV therapy > 30 days prior to study drug administration.
  • Subject's HIV RNA is >= 1000 copies/mL at screening.
  • If sexually active, subject agrees to use safe sex practices to reduce risk of HIV transmission (e.g., male or female condom, vaginal dam, etc.).
  • If female, the results of a urine pregnancy test performed at screening and on Day 1/Baseline are both negative.
  • 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:

    • A. Condoms, sponge, foams, jellies, diaphragm or intrauterine device.
    • B. A vasectomized partner.
    • C. Total abstinence from sexual intercourse.
  • Subject is not breastfeeding.
  • Subject's vital signs, physical examination, and laboratory results do not exhibit evidence of acute illness.
  • Subject has a Karnofsky score greater than or equal to 70.
  • Subject agrees not to take any drugs during the study, including over-the-counter medicines, vitamins, mineral supplements, herbal preparations, alcohol, or recreational drugs without the knowledge and permission of the investigator.
  • Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of initiating study drug.
  • 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

  • A subject will be excluded from the study if he/she meets any of the following criteria:
  • Subject has a history of an allergic reaction or significant sensitivity to lopinavir, ritonavir, lamivudine, zidovudine, efavirenz, or to any inert materials contained in the study drug formulations.
  • Subject has 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 participation in this study.
  • Subject is currently taking any drug (medicinal or herbal) that is contraindicated and/or not to be co-administered with any of the three study drugs as defined in the current locally approved prescribing information.
  • Subject has a history of drug and/or alcohol abuse or psychiatric illness that in the investigator's opinion could preclude compliance with the protocol.
  • Subject is receiving immunomodulatory agents, colony stimulating factor, bone marrow stimulants (e.g., erythropoietin [Procrit®, Epogen®] or filgrastim [Neupogen®]), ganciclovir, interferon-alpha, and other bone marrow suppressive or cytotoxic agents.
  • The TRUGENE HIV-1 resistance report indicates resistance or possible resistance to the study reverse transcriptase inhibitor(s) [RTI(s)] (efavirenz, lamivudine or zidovudine) OR the presence of any mutation in the protease gene leading to an amino acid substitution at the following loci: 8, 30, 32, 46, 47, 48, 50, 54, 82, 84, or 90 OR four or more mutations at the following loci: 10, 20, 24, 36, 53, 63, or 71.
  • Screening laboratory analyses show any of the following abnormal laboratory results: Presence of Hepatitis B surface antigen (HBsAg); Hemoglobin <= 9.5 g/dL; Absolute neutrophil count <= 1000 cells/mL; Platelet count <= 50,000 per mL; ALT (SGPT) or AST (SGOT) >= 3.0 x Upper Limit of Normal (ULN); Fasting Triglycerides > 750 mg/dL; Fasting Cholesterol > 300 mg/dL; Creatinine >= 1.5 x Upper Limit of Normal (ULN); Fasting serum glucose > 126 mg/dL
  • Subject is taking a prescribed lipid lowering medication such as HMG-CoA Reductase Inhibitors (statin) or fibrate medications.
  • Subject has a history of diabetes mellitus.
  • Subject has received any investigational drug or vaccine within 30 days prior to study drug administration.
  • For any reason, subject is considered by the investigator to be an unsuitable candidate to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075231

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United States, California
Fountain Valley Regional Hospital and Medical Center
Fountain Valley, California, United States, 92708
Sponsors and Collaborators
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Study Director: Barbara da Silva, M.D. Abbott
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00075231    
Other Study ID Numbers: M03-613
First Posted: January 8, 2004    Key Record Dates
Last Update Posted: October 2, 2006
Last Verified: September 2006
Keywords provided by Abbott:
Treatment Naive
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Genital Diseases
Urogenital Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine, zidovudine drug combination
HIV Protease Inhibitors
Viral Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors