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

Condition(s) targeted: HIV Infections

Intervention: Efavirenz (Drug); Lamivudine (Drug); Zidovudine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Glaxo Wellcome

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.

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

Study design: Treatment, Double-Blind, Safety Study

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): 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.

Hosp Muniz, Buenos Aires, Argentina

CAICI, Rosario - Santa Fe, Argentina

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

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

Southern Alberta HIV Clinic / Foothills Hosp, Calgary, Alberta, Canada

Phoenix Body Positive, Phoenix, Arizona 85016, United States

Saint Paul's Hosp, Vancouver, British Columbia, Canada

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Sunnybrook Health Science Centre, Toronto, Ontario, Canada

Toronto Gen Hosp, Toronto, Ontario, Canada

Wellesley/Central Site / St Michael's Hospital, Toronto, Ontario, Canada

Clinique Medicale L'Actuele, Montreal, Quebec, Canada

Clinique Medicale du Quartier Latin, Montreal, Quebec, Canada

Centre Hospitalier Universitaire de Quebec, Ste Foy, Quebec, Canada

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

Univ of Tennessee, Memphis, Tennessee 38163, United States

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

Methodist Healthcare, Memphis, Tennessee 38104, United States

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

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

Starting date: September 1999
Last updated: June 23, 2005