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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00043966
• Other study ID #: M02-418
• Status: Completed
• Phase: Phase 3
• First received: August 15, 2002
• Last updated: July 26, 2006
• Start date: July 2002

Study information

• Verified date: July 2006
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lopinavir/ritonavir

• Tenofovir DF

• Emtricitabine

Locations

Country	Name	City	State
Australia	Ground Zero Medical Centre / AIDS Research Initiative	Darlinghurst	New South Wales
Australia	Holdsworth House General Practice	Darlinghurst	New South Wales
France	CHU Kremlin Bicetre	Le Kremlin Bicetre
France	Hopital l'Archet	Nice
France	Hopital Bichat	Paris
France	Hopital Saint Antoine	Paris	Cedex 12
France	Hopital Saint Louis	Paris	Cedex 10
France	Hopital Tenon	Paris	Cedex 20
Germany	Klinikum J.W. Goethe Universitat	Frankfurt
Germany	Klinik I fur Innere Medizin der Universitat zu Koln	Koln
Singapore	Tan Tock Seng Hospital	Tan Tock Seng
Spain	Hospital Germans Trias I Pujol	Badalona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Vall D'Hebron	Barcelona
Spain	L'Hospitalet de Llobregat	Barcelona
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital de Mostolesi	Madrid
Spain	Hospital La Paz	Madrid
United Kingdom	Brighton General Hospital	E. Sussex
United Kingdom	Royal Free Hospital	London
United Kingdom	St. Mary Hospital	London
United Kingdom	St. Stephen's Centre Chelsea & Westminster Hospital	London
United Kingdom	The Caldecot Centre King's Healthcare NHS Trust	London
United States	Akron Infectious Disease, Inc.	Akron	Ohio
United States	IDS Research Initiative	Altamonte Springs	Florida
United States	AIDS Research Consortium of Atlanta Inc.	Atlanta	Georgia
United States	South Florida Clinical Research	Atlantis	Florida
United States	Central Texas Clinical Research	Austin	Texas
United States	Pacific Oaks Research	Beverly Hills	California
United States	Associates in Research	Fort Myers	Florida
United States	Orange County Center for Special Immunology	Fountain Valley	California
United States	Comprehensive Care Center	Ft. Lauderdale	Florida
United States	Gary J. Richmond, MD	Ft. Lauderdale,	Florida
United States	Hampton Roads Medical Specialists	Hampton	Virginia
United States	Joseph C. Gathe, Jr, MD	Houston	Texas
United States	Southampton Medical Group	Houston	Texas
United States	Living Hope Clinical Foundation	Long Beach	California
United States	AIDS Healthcare Foundation Research Center	Los Angeles	California
United States	Drs. Combs and Lutz	New Orleans	Louisiana
United States	Polari Medical Group	New York	New York
United States	St. Michael's Medical Center	Newark	New Jersey
United States	Triangle Medical	Philadelphia	Pennsylvania
United States	Philadelphia FIGHT	Philadelphia,	Pennsylvania
United States	Phoenix Body Positive	Phoenix,	Arizona
United States	Morris, Sklaver, Mestre & Denney, M.D., PA	Plantation	Florida
United States	The Research & Education Group	Portland	Oregon
United States	Health Positive	Safety Harbor	Florida
United States	Infectious Disease Research Institute, Inc.	Tampa	Florida
United States	Associates in Medical and Mental Health, P.C.	Tulsa	Oklahoma
United States	Treasure Coast Infectious Disease Consultants	Vero Beach	Florida
United States	Donna E. Sweet, MD	Wichita,	Kansas
United States	Wake Forest University School of Medicine	Winston-Salem,	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Singapore,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48