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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004852
• Other study ID #: 225D
• Secondary ID: EPV2000 1
• Status: Completed
• Phase: Phase 2
• First received: March 2, 2000
• Last updated: June 23, 2005
• Start date: September 1999

Study information

• Verified date: August 2000
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Efavirenz

• Lamivudine

• Zidovudine

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Glaxo Wellcome

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Canada,  Puerto Rico,