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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Drug: Kaletra® (lopinavir/ritonavir) Drug: Combivir® (lamivudine, zidovudine) Drug: Sustiva® (efavirenz)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
- Proportion of subjects with a plasma HIV RNA level below 50 copies/mL at Week 96.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, California|
|Fountain Valley Regional Hospital and Medical Center|
|Fountain Valley, California, United States, 92708|
|Study Director:||Barbara da Silva, M.D.||Abbott|
|Other Study ID Numbers:||
|First Posted:||January 8, 2004 Key Record Dates|
|Last Update Posted:||October 2, 2006|
|Last Verified:||September 2006|
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lamivudine, zidovudine drug combination
HIV Protease Inhibitors
Viral Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors