Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00043966
First received: August 15, 2002
Last updated: July 26, 2006
Last verified: July 2006
  Purpose

The purpose of this study is to compare the safety, tolerability and antiviral activity between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further characterize the pharmacokinetics of once-daily dosing of lopinavir/ritonavir.


Condition Intervention Phase
HIV Infections
Drug: Lopinavir/ritonavir
Drug: Tenofovir DF
Drug: Emtricitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label Study of 800 Mg Lopinavir/200 Mg Ritonavir QD in Combination With Tenofovir and Emtricitabine Vs. 400 Mg Lopinavir /100 Mg Ritonavir BID in Combination With Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48

Estimated Enrollment: 200
Study Start Date: July 2002
  Eligibility

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

Inclusion Criteria:

  • Subject is at least 18 years of age.
  • If female, subject is 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) *contraceptives (oral or parenteral) for three months prior to study drug administration) *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) and a urine pregnancy test performed on Study Day -1 are both negative and the subject agrees to use a barrier method of contraception throughout the study.
  • 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 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, herbal medications, alcohol or recreational drugs without the knowledge and permission of the principal investigator.
  • Subject has a Karnofsky Score greater than or equal to 70
  • Subject has not been treated for an active AIDS-defining opportunistic infection within 30 days of screening. Subjects who are on stable maintenance therapy for an opportunistic infection may be enrolled after consultation with Abbott.
  • Subject is naive to antiretroviral treatment (< 7 days ARV treatment).
  • Subject has a plasma HIV RNA level of greater than 1,000 copies/mL at screening.
  • Subject agrees to take all doses of the lopinavir/ritonavir from the bottles provided by the sponsor (rather than take doses from a personal “dosette” 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 lopinavir/ritonavir, tenofovir or emtricitabine or to drugs similar to study drug.
  • Subject has a recent (within the past 6 months) history of drug and/or alcohol abuse.
  • Subject has a positive result on the screening tests for drugs of abuse.
  • 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 ≤ 8.0 g/dL *Absolute neutrophil count ≤ 750 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00043966

  Hide Study Locations
Locations
United States, Arizona
Phoenix Body Positive
Phoenix,, Arizona, United States, 85006
United States, California
Pacific Oaks Research
Beverly Hills, California, United States, 90211
Orange County Center for Special Immunology
Fountain Valley, California, United States, 92708
Living Hope Clinical Foundation
Long Beach, California, United States, 90813
AIDS Healthcare Foundation Research Center
Los Angeles, California, United States, 90027
United States, Florida
IDS Research Initiative
Altamonte Springs, Florida, United States, 32701
South Florida Clinical Research
Atlantis, Florida, United States, 33462
Associates in Research
Fort Myers, Florida, United States, 33901
Comprehensive Care Center
Ft. Lauderdale, Florida, United States, 33311
Gary J. Richmond, MD
Ft. Lauderdale,, Florida, United States, 33316
Morris, Sklaver, Mestre & Denney, M.D., PA
Plantation, Florida, United States, 33317
Health Positive
Safety Harbor, Florida, United States, 34695
Infectious Disease Research Institute, Inc.
Tampa, Florida, United States, 33614
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
United States, Georgia
AIDS Research Consortium of Atlanta Inc.
Atlanta, Georgia, United States, 30308
United States, Kansas
Donna E. Sweet, MD
Wichita,, Kansas, United States, 67214
United States, Louisiana
Drs. Combs and Lutz
New Orleans, Louisiana, United States, 70115
United States, New Jersey
St. Michael's Medical Center
Newark, New Jersey, United States, 07102-9880
United States, New York
Polari Medical Group
New York, New York, United States, 10011
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem,, North Carolina, United States, 27157-1042
United States, Ohio
Akron Infectious Disease, Inc.
Akron, Ohio, United States, 44304
United States, Oklahoma
Associates in Medical and Mental Health, P.C.
Tulsa, Oklahoma, United States, 74114
United States, Oregon
The Research & Education Group
Portland, Oregon, United States, 97209-2535
United States, Pennsylvania
Triangle Medical
Philadelphia, Pennsylvania, United States, 19107
Philadelphia FIGHT
Philadelphia,, Pennsylvania, United States, 19107
United States, Texas
Central Texas Clinical Research
Austin, Texas, United States, 78705
Joseph C. Gathe, Jr, MD
Houston, Texas, United States, 77004
Southampton Medical Group
Houston, Texas, United States, 77098
United States, Virginia
Hampton Roads Medical Specialists
Hampton, Virginia, United States, 23666
Australia, New South Wales
Holdsworth House General Practice
Darlinghurst, New South Wales, Australia, 2010
Ground Zero Medical Centre / AIDS Research Initiative
Darlinghurst, New South Wales, Australia, 2010
France
Hopital Saint Louis
Paris, Cedex 10, France, 75475
Hopital Saint Antoine
Paris, Cedex 12, France, 75571
Hopital Tenon
Paris, Cedex 20, France, 75970
CHU Kremlin Bicetre
Le Kremlin Bicetre, France, 94272
Hopital l'Archet
Nice, France, 06202
Hopital Bichat
Paris, France, 75018
Germany
Klinikum J.W. Goethe Universitat
Frankfurt, Germany, D-60590
Klinik I fur Innere Medizin der Universitat zu Koln
Koln, Germany, D-505924
Singapore
Tan Tock Seng Hospital
Tan Tock Seng, Singapore, 308433
Spain
Hospital Germans Trias I Pujol
Badalona, Spain, 08916
L'Hospitalet de Llobregat
Barcelona, Spain, 08907
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08025
Hospital Vall D'Hebron
Barcelona, Spain, 08035
Hospital 12 de Octubre
Madrid, Spain, 28041
Hospital La Paz
Madrid, Spain, 28046
Hospital de Mostolesi
Madrid, Spain, 28935
United Kingdom
Brighton General Hospital
E. Sussex, United Kingdom, BN2 3EW
The Caldecot Centre King's Healthcare NHS Trust
London, United Kingdom, SE5 9RS
Royal Free Hospital
London, United Kingdom, NW3 2QG
St. Stephen's Centre Chelsea & Westminster Hospital
London, United Kingdom, SW10 9TH
St. Mary Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Abbott
Investigators
Study Director: Scott Brun, M.D. Global Project Head, Antiviral Global Project Team
  More Information

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00043966     History of Changes
Other Study ID Numbers: M02-418
Study First Received: August 15, 2002
Last Updated: July 26, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
treatment naive

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Ritonavir
Lopinavir
Tenofovir
Tenofovir disoproxil
Emtricitabine
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014