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

July 26, 2006 updated by: Abbott

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Holdsworth House General Practice
      • Darlinghurst, New South Wales, Australia, 2010
        • Ground Zero Medical Centre / AIDS Research Initiative
  • France
      • Le Kremlin Bicetre, France, 94272
        • CHU Kremlin Bicetre
      • Nice, France, 06202
        • Hôpital l'Archet
      • Paris, France, 75018
        • Hôpital Bichat
    • Cedex 10
      • Paris, Cedex 10, France, 75475
        • Hopital Saint Louis
    • Cedex 12
      • Paris, Cedex 12, France, 75571
        • Hopital Saint Antoine
    • Cedex 20
      • Paris, Cedex 20, France, 75970
        • Hôpital Tenon
  • Germany
      • Frankfurt, Germany, D-60590
        • Klinikum J.W. Goethe Universitat
      • Koln, Germany, D-505924
        • Klinik I fur Innere Medizin der Universitat zu Koln
  • Singapore
      • Tan Tock Seng, Singapore, 308433
        • Tan Tock Seng Hospital
  • Spain
      • Badalona, Spain, 08916
        • Hospital Germans Trías i Pujol
      • Barcelona, Spain, 08035
        • Hospital Vall d'hebrón
      • Barcelona, Spain, 08025
        • Hospital de La Santa Creu i Sant Pau
      • Barcelona, Spain, 08907
        • L'Hospitalet de Llobregat
      • Madrid, Spain, 28046
        • Hospital La Paz
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre
      • Madrid, Spain, 28935
        • Hospital de Mostolesi
  • United Kingdom
      • E. Sussex, United Kingdom, BN2 3EW
        • Brighton General Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, SE5 9RS
        • The Caldecot Centre King's Healthcare NHS Trust
      • London, United Kingdom, SW10 9TH
        • St. Stephen's Centre Chelsea & Westminster Hospital
      • London, United Kingdom, W2 1NY
        • St. Mary Hospital
  • United States
    • Arizona
      • Phoenix,, Arizona, United States, 85006
        • Phoenix Body Positive
    • California
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Research
      • Fountain Valley, California, United States, 92708
        • Orange County Center for Special Immunology
      • Long Beach, California, United States, 90813
        • Living Hope Clinical Foundation
      • Los Angeles, California, United States, 90027
        • AIDS Healthcare Foundation Research Center
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDS Research Initiative
      • Atlantis, Florida, United States, 33462
        • South Florida Clinical Research
      • Fort Myers, Florida, United States, 33901
        • Associates in Research
      • Ft. Lauderdale, Florida, United States, 33311
        • Comprehensive Care Center
      • Ft. Lauderdale,, Florida, United States, 33316
        • Gary J. Richmond, MD
      • Plantation, Florida, United States, 33317
        • Morris, Sklaver, Mestre & Denney, M.D., PA
      • Safety Harbor, Florida, United States, 34695
        • Health Positive
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute, Inc.
      • Vero Beach, Florida, United States, 32960
        • Treasure Coast Infectious Disease Consultants
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta Inc.
    • Kansas
      • Wichita,, Kansas, United States, 67214
        • Donna E. Sweet, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Drs. Combs and Lutz
    • New Jersey
      • Newark, New Jersey, United States, 07102-9880
        • St. Michael's Medical Center
    • New York
      • New York, New York, United States, 10011
        • Polari Medical Group
    • North Carolina
      • Winston-Salem,, North Carolina, United States, 27157-1042
        • Wake Forest University School of Medicine
    • Ohio
      • Akron, Ohio, United States, 44304
        • Akron Infectious Disease, Inc.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Associates in Medical and Mental Health, P.C.
    • Oregon
      • Portland, Oregon, United States, 97209-2535
        • The Research & Education Group
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Triangle Medical
      • Philadelphia,, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
    • Texas
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • Houston, Texas, United States, 77004
        • Joseph C. Gathe, Jr, MD
      • Houston, Texas, United States, 77098
        • Southampton Medical Group
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Medical Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Proportion of subjects with plasma HIV RNA level below 50 copies/mL at week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Scott Brun, M.D., Global Project Head, Antiviral Global Project Team

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2002

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2002

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2002

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2002

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2006

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2006

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M02-418

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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