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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00004852
First received: March 2, 2000
Last updated: June 23, 2005
Last verified: August 2000
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Efavirenz
Drug: Lamivudine
Drug: Zidovudine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Study Start Date: September 1999
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004852

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

No publications provided

ClinicalTrials.gov Identifier: NCT00004852     History of Changes
Other Study ID Numbers: 225D, EPV2000 1
Study First Received: March 2, 2000
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
HIV-1
Drug Therapy, Combination
Zidovudine
Drug Administration Schedule
Lamivudine
Genotype
Phenotype
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
efavirenz

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Zidovudine
Lamivudine
Reverse Transcriptase Inhibitors
Efavirenz
Anti-HIV Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014