Clinical trial NCT00004852: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV-1
Drug Therapy, Combination
Zidovudine
Drug Administration Schedule
Lamivudine
Genotype
Phenotype
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.

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 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.

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