Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Naïve Subjects
- Conditions
- HIV Infections
- Registration Number
- NCT00043966
- Lead Sponsor
- Abbott
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (52)
Phoenix Body Positive
🇺🇸Phoenix,, Arizona, United States
Akron Infectious Disease, Inc.
🇺🇸Akron, Ohio, United States
Donna E. Sweet, MD
🇺🇸Wichita,, Kansas, United States
Hopital Tenon
🇫🇷Paris, Cedex 20, France
Hampton Roads Medical Specialists
🇺🇸Hampton, Virginia, United States
Tan Tock Seng Hospital
🇸🇬Tan Tock Seng, Singapore
Morris, Sklaver, Mestre & Denney, M.D., PA
🇺🇸Plantation, Florida, United States
Health Positive
🇺🇸Safety Harbor, Florida, United States
Associates in Medical and Mental Health, P.C.
🇺🇸Tulsa, Oklahoma, United States
Infectious Disease Research Institute, Inc.
🇺🇸Tampa, Florida, United States
Comprehensive Care Center
🇺🇸Ft. Lauderdale, Florida, United States
Living Hope Clinical Foundation
🇺🇸Long Beach, California, United States
CHU Kremlin Bicetre
🇫🇷Le Kremlin Bicetre, France
Hospital La Paz
🇪🇸Madrid, Spain
IDS Research Initiative
🇺🇸Altamonte Springs, Florida, United States
Ground Zero Medical Centre / AIDS Research Initiative
🇦🇺Darlinghurst, New South Wales, Australia
Pacific Oaks Research
🇺🇸Beverly Hills, California, United States
Gary J. Richmond, MD
🇺🇸Ft. Lauderdale,, Florida, United States
The Research & Education Group
🇺🇸Portland, Oregon, United States
South Florida Clinical Research
🇺🇸Atlantis, Florida, United States
St. Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Treasure Coast Infectious Disease Consultants
🇺🇸Vero Beach, Florida, United States
Klinikum J.W. Goethe Universitat
🇩🇪Frankfurt, Germany
Hopital Bichat
🇫🇷Paris, France
Brighton General Hospital
🇬🇧E. Sussex, United Kingdom
Klinik I fur Innere Medizin der Universitat zu Koln
🇩🇪Koln, Germany
St. Stephen's Centre Chelsea & Westminster Hospital
🇬🇧London, United Kingdom
Wake Forest University School of Medicine
🇺🇸Winston-Salem,, North Carolina, United States
Hospital 12 de Octubre
🇪🇸Madrid, Spain
Hospital de Mostolesi
🇪🇸Madrid, Spain
Philadelphia FIGHT
🇺🇸Philadelphia,, Pennsylvania, United States
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
AIDS Healthcare Foundation Research Center
🇺🇸Los Angeles, California, United States
AIDS Research Consortium of Atlanta Inc.
🇺🇸Atlanta, Georgia, United States
Triangle Medical
🇺🇸Philadelphia, Pennsylvania, United States
Joseph C. Gathe, Jr, MD
🇺🇸Houston, Texas, United States
Southampton Medical Group
🇺🇸Houston, Texas, United States
Hospital Vall D'Hebron
🇪🇸Barcelona, Spain
L'Hospitalet de Llobregat
🇪🇸Barcelona, Spain
Hopital l'Archet
🇫🇷Nice, France
Hospital Germans Trias I Pujol
🇪🇸Badalona, Spain
The Caldecot Centre King's Healthcare NHS Trust
🇬🇧London, United Kingdom
St. Mary Hospital
🇬🇧London, United Kingdom
Orange County Center for Special Immunology
🇺🇸Fountain Valley, California, United States
Associates in Research
🇺🇸Fort Myers, Florida, United States
Drs. Combs and Lutz
🇺🇸New Orleans, Louisiana, United States
Polari Medical Group
🇺🇸New York, New York, United States
Holdsworth House General Practice
🇦🇺Darlinghurst, New South Wales, Australia
Central Texas Clinical Research
🇺🇸Austin, Texas, United States
Hopital Saint Louis
🇫🇷Paris, Cedex 10, France
Hopital Saint Antoine
🇫🇷Paris, Cedex 12, France
Royal Free Hospital
🇬🇧London, United Kingdom