Clinical Trial: 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.

Sponsored by: Glaxo Wellcome
Information provided by: AIDS Clinical Trials Information Service

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 Treatment or Intervention Phase
HIV Infections
 Drug: Efavirenz
 Drug: Lamivudine
 Drug: Zidovudine
Phase II

MedlinePlus related topics:  AIDS

Study Type: Interventional
Study Design: Treatment, Double-Blind, Safety Study

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

Further Study Details: 

Study start: September 1999

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 above,  Genders Eligible for Study:  Both

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.

Location Information


Arizona
      Phoenix Body Positive, Phoenix,  Arizona,  85016,  United States

California
      Davies Med Ctr / c/o HIV Institute, San Francisco,  California,  94114,  United States

      Harbor - UCLA Med Ctr, Torrance,  California,  90509,  United States

      Kaiser Foundation Hospital, San Francisco,  California,  94118,  United States

      Pacific Oaks Research, Beverly Hills,  California,  90211,  United States

      Tower ID Med Associates, Los Angeles,  California,  90048,  United States

      AIDS Healthcare Foundation, Los Angeles,  California,  900276069,  United States

District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States

      George Washington Univ Med Ctr, Washington,  District of Columbia,  20037,  United States

Florida
      TheraFirst Med Ctrs Inc, Fort Lauderdale,  Florida,  33308,  United States

      North Broward Hosp District, Fort Lauderdale,  Florida,  33316,  United States

      IDC Research Initiative, Altamonte Springs,  Florida,  32701,  United States

      Bach and Godofsky, Bradenton,  Florida,  34205,  United States

      The Coleman Institute Inc, Fort Lauderdale,  Florida,  33334,  United States

      The Coleman Institute Inc, Fort Pierce,  Florida,  34950,  United States

Georgia
      Kaiser Permanente Infectious Diseases, Atlanta,  Georgia,  30339,  United States

Illinois
      AIDS Research Alliance - Chicago, Chicago,  Illinois,  60657,  United States

Indiana
      Infectious Disease of Indiana, Indianapolis,  Indiana,  46218,  United States

Kentucky
      Univ of Kentucky Med Ctr, Lexington,  Kentucky,  40536,  United States

Louisiana
      Tulane Univ School of Medicine, New Orleans,  Louisiana,  70112,  United States

Massachusetts
      Boston Med Ctr / Evans - 556, Boston,  Massachusetts,  021182393,  United States

Missouri
      Antibiotic Research Associates, Kansas City,  Missouri,  64132,  United States

New Jersey
      ID Care Inc, Somerville,  New Jersey,  08876,  United States

      East Orange Veterans Administration Med Ctr, East Orange,  New Jersey,  07018,  United States

      ID Care Inc, Princeton,  New Jersey,  08540,  United States

      ID Care Inc, New Brunswick,  New Jersey,  08901,  United States

      ID Care Inc, Randolph,  New Jersey,  07869,  United States

New York
      North Shore Univ Hosp / Div of Infectious Diseases, Manhasset,  New York,  11030,  United States

      St Lukes / Roosevelt Hosp / HIV Center, New York,  New York,  10019,  United States

      Albany Med College / Div of HIV Medicine, Albany,  New York,  12208,  United States

      St Vincents Hosp / Clinical Research Program, New York,  New York,  10011,  United States

Ohio
      Ohio State Univ Hosp Clinic, Columbus,  Ohio,  432101228,  United States

Oklahoma
      Associates in Med and Mental Health, Tulsa,  Oklahoma,  74114,  United States

      Oklahoma State University / College of Osteopathic Medicine, Tulsa,  Oklahoma,  74107,  United States

Rhode Island
      Miriam Hosp / Brown Univ, Providence,  Rhode Island,  02906,  United States

Tennessee
      Univ of Tennessee, Memphis,  Tennessee,  38163,  United States

      Vanderbilt Univ Med Ctr, Nashville,  Tennessee,  37203,  United States

      Methodist Healthcare, Memphis,  Tennessee,  38104,  United States

Texas
      Dr David Donnell, Dallas,  Texas,  75219,  United States

      Nelson-Tebedo Community Clinic, Dallas,  Texas,  75219,  United States

      Baylor College of Medicine / Dept of Medicine, Houston,  Texas,  770303498,  United States

      Univ of Texas / Med School at Houston, Houston,  Texas,  77030,  United States

      Univ of Texas Health Sciences Ctr, San Antonio,  Texas,  782847838,  United States

      Univ of Texas Med Branch, Galveston,  Texas,  77555,  United States

      Montrose Clinic, Houston,  Texas,  77006,  United States

Virginia
      Hampton Roads Med Specialists, Hampton,  Virginia,  23666,  United States

Argentina
      Hosp Muniz, Buenos Aires,  Argentina

      CAICI, Rosario Santa Fe,  Argentina

Brazil
      Hosp Evandro Chagas Fioernz, Manguinhos RJ,  Brazil

      Hosp Sao Paulo da Universidade Federal de Sao Paulo, Sao Paulo - SP,  Brazil

      Universidade de Campinas, Campinas - SP,  Brazil

      Hosp Univ Pedro Ernesto / Univ Estadual do RJ, Rio de Janeiro - RJ,  Brazil

      Hosp Univ Clementino Fraga Filho, Rio de Janeiro - RJ,  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
      San Juan AIDS Program, Santurce,  00908,  Puerto Rico

      Caguas Regional Hosp, Caguas,  00726,  Puerto Rico

      Carlos Leon-Valiente MD, Guaynabo,  00966,  Puerto Rico

      Hosp San Cristobal-Edif A, Cotto Laurel,  00780,  Puerto Rico

      Ramon Ramirez Ronda MD, Mayaguez,  00680,  Puerto Rico

More Information

Study ID Numbers:  225D; EPV2000 1
Record last reviewed:  August 2000
Last Updated:  October 13, 2004
Record first received:  March 2, 2000
ClinicalTrials.gov Identifier:  NCT00004852
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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