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.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
CHU Kremlin Bicetre, Le Kremlin Bicetre 94272, France
Hopital l'Archet, Nice 06202, France
Hopital Bichat, Paris 75018, France
Klinikum J.W. Goethe Universitat, Frankfurt D-60590, Germany
Klinik I fur Innere Medizin der Universitat zu Koln, Koln D-505924, 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 de Mostolesi, Madrid 28935, Spain
Hospital La Paz, Madrid 28046, Spain
Brighton General Hospital, E. Sussex BN2 3EW, United Kingdom
Royal Free Hospital, London NW3 2QG, United Kingdom
St. Mary Hospital, London W2 1NY, United Kingdom
St. Stephen's Centre Chelsea & Westminster Hospital, London SW10 9TH, United Kingdom
The Caldecot Centre King's Healthcare NHS Trust, London SE5 9RS, United Kingdom
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
Hopital Saint Louis, Paris, Cedex 10 75475, France
Hopital Saint Antoine, Paris, Cedex 12 75571, France
Hopital Tenon, Paris, Cedex 20 75970, France
IDS Research Initiative, Altamonte Springs, Florida 32701, United States
South Florida Clinical Research, Atlantis, Florida 33462, United States
Associates in Research, Fort Myers, Florida 33901, United States
Gary J. Richmond, MD, Ft. Lauderdale,, Florida 33316, United States
Comprehensive Care Center, Ft. Lauderdale, Florida 33311, 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
Ground Zero Medical Centre / AIDS Research Initiative, Darlinghurst, New South Wales 2010, Australia
Holdsworth House General Practice, Darlinghurst, New South Wales 2010, Australia
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