Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
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
1 other identifier
interventional
200
7 countries
52
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 15, 2002
CompletedFirst Posted
Study publicly available on registry
August 19, 2002
CompletedJuly 27, 2006
July 1, 2006
August 15, 2002
July 26, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
Study Sites (52)
Phoenix Body Positive
Phoenix, Arizona, 85006, United States
Pacific Oaks Research
Beverly Hills, California, 90211, United States
Orange County Center for Special Immunology
Fountain Valley, California, 92708, United States
Living Hope Clinical Foundation
Long Beach, California, 90813, United States
AIDS Healthcare Foundation Research Center
Los Angeles, California, 90027, United States
IDS Research Initiative
Altamonte Springs, Florida, 32701, United States
South Florida Clinical Research
Atlantis, Florida, 33462, United States
Comprehensive Care Center
Fort Lauderdale, Florida, 33311, United States
Gary J. Richmond, MD
Fort Lauderdale, Florida, 33316, United States
Associates in Research
Fort Myers, Florida, 33901, United States
Morris, Sklaver, Mestre & Denney, M.D., PA
Plantation, Florida, 33317, United States
Health Positive
Safety Harbor, Florida, 34695, United States
Infectious Disease Research Institute, Inc.
Tampa, Florida, 33614, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
AIDS Research Consortium of Atlanta Inc.
Atlanta, Georgia, 30308, United States
Donna E. Sweet, MD
Wichita, Kansas, 67214, United States
Drs. Combs and Lutz
New Orleans, Louisiana, 70115, United States
St. Michael's Medical Center
Newark, New Jersey, 07102-9880, United States
Polari Medical Group
New York, New York, 10011, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27157-1042, United States
Akron Infectious Disease, Inc.
Akron, Ohio, 44304, United States
Associates in Medical and Mental Health, P.C.
Tulsa, Oklahoma, 74114, United States
The Research & Education Group
Portland, Oregon, 97209-2535, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, 19107, United States
Triangle Medical
Philadelphia, Pennsylvania, 19107, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Joseph C. Gathe, Jr, MD
Houston, Texas, 77004, United States
Southampton Medical Group
Houston, Texas, 77098, United States
Hampton Roads Medical Specialists
Hampton, Virginia, 23666, United States
Ground Zero Medical Centre / AIDS Research Initiative
Darlinghurst, New South Wales, 2010, Australia
Holdsworth House General Practice
Darlinghurst, New South Wales, 2010, Australia
Hopital Saint Louis
Paris, Cedex 10, 75475, France
Hopital Saint Antoine
Paris, Cedex 12, 75571, France
Hopital Tenon
Paris, Cedex 20, 75970, France
CHU Kremlin Bicetre
Le Kremlin-Bicêtre, 94272, France
Hopital l'Archet
Nice, 06202, France
Hopital Bichat
Paris, 75018, France
Klinik I fur Innere Medizin der Universitat zu Koln
Cologne, D-505924, Germany
Klinikum J.W. Goethe Universitat
Frankfurt, D-60590, Germany
Tan Tock Seng Hospital
Tan Tock Seng, 308433, Singapore
Hospital Germans Trias I Pujol
Badalona, 08916, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Vall D'Hebron
Barcelona, 08035, Spain
L'Hospitalet de Llobregat
Barcelona, 08907, Spain
Hospital 12 de Octubre
Madrid, 28041, Spain
Hospital La Paz
Madrid, 28046, Spain
Hospital de Mostolesi
Madrid, 28935, Spain
Brighton General Hospital
E. Sussex, BN2 3EW, United Kingdom
Royal Free Hospital
London, NW3 2QG, United Kingdom
The Caldecot Centre King's Healthcare NHS Trust
London, SE5 9RS, United Kingdom
St. Stephen's Centre Chelsea & Westminster Hospital
London, SW10 9TH, United Kingdom
St. Mary Hospital
London, W2 1NY, United Kingdom
Related Publications (1)
Podsadecki TJ, Vrijens BC, Tousset EP, Rode RA, Hanna GJ. Decreased adherence to antiretroviral therapy observed prior to transient human immunodeficiency virus type 1 viremia. J Infect Dis. 2007 Dec 15;196(12):1773-8. doi: 10.1086/523704.
PMID: 18190257DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Scott Brun, M.D.
Global Project Head, Antiviral Global Project Team
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 15, 2002
First Posted
August 19, 2002
Study Start
July 1, 2002
Last Updated
July 27, 2006
Record last verified: 2006-07