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Study of Lopinavir, Ritonavir, Tenofovir and Emtricitabine in HIV-Infected Antiretroviral Na�ve Subjects

Information source: Abbott
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV Infections

Intervention: Lopinavir/ritonavir (Drug); Tenofovir DF (Drug); Emtricitabine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Scott Brun, M.D., Study Director, Affiliation: Global Project Head, Antiviral Global Project Team

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.

Clinical Details

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 Nave Subjects

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

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

Additional Information

Starting date: July 2002
Last updated: July 26, 2006

Page last updated: August 20, 2015

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