Safety and Effectiveness of Lamivudine When Given Once a Day Versus Twice a Day in Combination With Other Anti-HIV Drugs in HIV-Infected Adults Who Have Never Received Anti-HIV Drugs

June 23, 2005 updated by: Glaxo Wellcome

A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg Once Daily Vs. Lamivudine 150mg BID in Combination With Zidovudine 300mg BID and Efavirenz 600mg Once Daily in Antiretroviral-Naive Adults With HIV-1 Infection

The purpose of this study is to look at the safety and effectiveness of receiving lamivudine (3TC) once a day versus twice a day as part of an anti-HIV drug combination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to receive the same total dosage of 3TC either twice a day (Group 1) or once a day (Group 2) in combination with ZDV and EFV over 48 weeks. Viral load measurements will be performed at Weeks 4, 8, 12, 16, 20, 24, and every 8 weeks thereafter.

Study Type

Interventional

Phase

  • Phase 2

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

  • Argentina
      • Buenos Aires, Argentina
        • Hosp Muniz
      • Rosario - Santa Fe, Argentina
        • CAICI
  • Brazil
      • Campinas - SP, Brazil
        • Universidade de Campinas
      • Manguinhos RJ, Brazil
        • Hosp Evandro Chagas Fioernz
      • Rio de Janeiro - RJ, Brazil
        • Hosp Univ Clementino Fraga Filho
      • Rio de Janeiro - RJ, Brazil
        • Hosp Univ Pedro Ernesto / Univ Estadual do RJ
      • Sao Paulo - SP, Brazil
        • Hosp Sao Paulo da Universidade Federal de Sao Paulo
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Southern Alberta HIV Clinic / Foothills Hosp
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Saint Paul's Hosp
    • Ontario
      • Toronto, Ontario, Canada
        • Sunnybrook Health Science Centre
      • Toronto, Ontario, Canada
        • Toronto Gen Hosp
      • Toronto, Ontario, Canada
        • Wellesley/Central Site / St Michael's Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique Medicale du Quartier Latin
      • Montreal, Quebec, Canada
        • Clinique Medicale L'Actuele
      • Ste Foy, Quebec, Canada
        • Centre Hospitalier Universitaire de Quebec
  • Puerto Rico
      • Caguas, Puerto Rico, 00726
        • Caguas Regional Hosp
      • Cotto Laurel, Puerto Rico, 00780
        • Hosp San Cristobal-Edif A
      • Guaynabo, Puerto Rico, 00966
        • Carlos Leon-Valiente MD
      • Mayaguez, Puerto Rico, 00680
        • Ramon Ramirez Ronda MD
      • Santurce, Puerto Rico, 00908
        • San Juan AIDS Program
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Body Positive
    • California
      • Beverly Hills, California, United States, 90211
        • Pacific Oaks Research
      • Los Angeles, California, United States, 90048
        • Tower ID Med Associates
      • Los Angeles, California, United States, 900276069
        • AIDS Healthcare Foundation
      • San Francisco, California, United States, 94118
        • Kaiser Foundation Hospital
      • San Francisco, California, United States, 94114
        • Davies Med Ctr / c/o HIV Institute
      • Torrance, California, United States, 90509
        • Harbor - UCLA Med Ctr
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington Univ Med Ctr
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDC Research Initiative
      • Bradenton, Florida, United States, 34205
        • Bach and Godofsky
      • Fort Lauderdale, Florida, United States, 33308
        • TheraFirst Med Ctrs Inc
      • Fort Lauderdale, Florida, United States, 33316
        • North Broward Hosp District
      • Fort Lauderdale, Florida, United States, 33334
        • The Coleman Institute Inc
      • Fort Pierce, Florida, United States, 34950
        • The Coleman Institute Inc
    • Georgia
      • Atlanta, Georgia, United States, 30339
        • Kaiser Permanente Infectious Diseases
    • Illinois
      • Chicago, Illinois, United States, 60657
        • AIDS Research Alliance - Chicago
    • Indiana
      • Indianapolis, Indiana, United States, 46218
        • Infectious Disease of Indiana
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Univ of Kentucky Med Ctr
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane Univ School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 021182393
        • Boston Med Ctr / Evans - 556
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Antibiotic Research Associates
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • East Orange Veterans Administration Med Ctr
      • New Brunswick, New Jersey, United States, 08901
        • ID Care Inc
      • Princeton, New Jersey, United States, 08540
        • ID Care Inc
      • Randolph, New Jersey, United States, 07869
        • ID Care Inc
      • Somerville, New Jersey, United States, 08876
        • ID Care Inc
    • New York
      • Albany, New York, United States, 12208
        • Albany Med College / Div of HIV Medicine
      • Manhasset, New York, United States, 11030
        • North Shore Univ Hosp / Div of Infectious Diseases
      • New York, New York, United States, 10011
        • St Vincents Hosp / Clinical Research Program
      • New York, New York, United States, 10019
        • St Lukes / Roosevelt Hosp / HIV Center
    • Ohio
      • Columbus, Ohio, United States, 432101228
        • Ohio State Univ Hosp Clinic
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74107
        • Oklahoma State University / College of Osteopathic Medicine
      • Tulsa, Oklahoma, United States, 74114
        • Associates in Med and Mental Health
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hosp / Brown Univ
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Methodist Healthcare
      • Memphis, Tennessee, United States, 38163
        • Univ of Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, United States, 75219
        • Nelson-Tebedo Community Clinic
      • Dallas, Texas, United States, 75219
        • Dr David Donnell
      • Galveston, Texas, United States, 77555
        • Univ of Texas Med Branch
      • Houston, Texas, United States, 77006
        • Montrose Clinic
      • Houston, Texas, United States, 770303498
        • Baylor College of Medicine / Dept of Medicine
      • Houston, Texas, United States, 77030
        • Univ of Texas / Med School at Houston
      • San Antonio, Texas, United States, 782847838
        • Univ of Texas Health Sciences Ctr
    • Virginia
      • Hampton, Virginia, United States, 23666
        • Hampton Roads Med 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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are 18 years of age or older.
  • Are HIV-positive.
  • Have a viral load (level of HIV in the blood) of at least 400 copies/ml within 21 days of study entry.
  • Have a CD4 count greater than 100 cells/mm3 within 21 days of study entry.
  • Agree to practice abstinence or use effective barrier methods of birth control (or, if patient is a woman, unable to have children).

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have taken any antiretroviral (anti-HIV) agent.
  • Are pregnant or breast-feeding.
  • Are unable to absorb food or have trouble taking medicines by mouth.
  • Abuse alcohol or drugs to an extent that may make study participation difficult.
  • Are not likely to be able to complete the 48 weeks of study treatment.
  • Have a history of pancreatitis (inflamed pancreas) or hepatitis within the last 6 months or any evidence of liver disease.
  • Have received an investigational vaccine within the past 3 months or have received gene therapy.
  • Have a severe medical condition such as diabetes or heart trouble.
  • Have been diagnosed with AIDS.
  • Have had radiation therapy or chemotherapy within 30 days of study entry, except for treatment of Kaposi's sarcoma.
  • Are taking medications that affect the immune system within 30 days of study entry.
  • Are taking medications that may interact with the study drugs.

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
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Glaxo Wellcome

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

September 1, 1999

Study Registration Dates

First Submitted

March 2, 2000

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

August 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 225D
  • EPV2000 1

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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