Back to resultsSafety 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
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Efavirenz
Lamivudine
Zidovudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring HIV-1, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, Lamivudine, Genotype, Phenotype, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, efavirenz
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.
Sites / Locations
- Phoenix Body Positive
- Pacific Oaks Research
- AIDS Healthcare Foundation
- Tower ID Med Associates
- Davies Med Ctr / c/o HIV Institute
- Kaiser Foundation Hospital
- Harbor - UCLA Med Ctr
- Georgetown Univ Med Ctr
- George Washington Univ Med Ctr
- IDC Research Initiative
- Bach and Godofsky
- TheraFirst Med Ctrs Inc
- North Broward Hosp District
- The Coleman Institute Inc
- The Coleman Institute Inc
- Kaiser Permanente Infectious Diseases
- AIDS Research Alliance - Chicago
- Infectious Disease of Indiana
- Univ of Kentucky Med Ctr
- Tulane Univ School of Medicine
- Boston Med Ctr / Evans - 556
- Antibiotic Research Associates
- East Orange Veterans Administration Med Ctr
- ID Care Inc
- ID Care Inc
- ID Care Inc
- ID Care Inc
- Albany Med College / Div of HIV Medicine
- North Shore Univ Hosp / Div of Infectious Diseases
- St Vincents Hosp / Clinical Research Program
- St Lukes / Roosevelt Hosp / HIV Center
- Ohio State Univ Hosp Clinic
- Oklahoma State University / College of Osteopathic Medicine
- Associates in Med and Mental Health
- Miriam Hosp / Brown Univ
- Methodist Healthcare
- Univ of Tennessee
- Vanderbilt Univ Med Ctr
- Dr David Donnell
- Nelson-Tebedo Community Clinic
- Univ of Texas Med Branch
- Montrose Clinic
- Baylor College of Medicine / Dept of Medicine
- Univ of Texas / Med School at Houston
- Univ of Texas Health Sciences Ctr
- Hampton Roads Med Specialists
- Hosp Muniz
- CAICI
- Universidade de Campinas
- Hosp Evandro Chagas Fioernz
- Hosp Univ Clementino Fraga Filho
- Hosp Univ Pedro Ernesto / Univ Estadual do RJ
- Hosp Sao Paulo da Universidade Federal de Sao Paulo
- Southern Alberta HIV Clinic / Foothills Hosp
- Saint Paul's Hosp
- Sunnybrook Health Science Centre
- Toronto Gen Hosp
- Wellesley/Central Site / St Michael's Hospital
- Clinique Medicale du Quartier Latin
- Clinique Medicale L'Actuele
- Centre Hospitalier Universitaire de Quebec
- Caguas Regional Hosp
- Hosp San Cristobal-Edif A
- Carlos Leon-Valiente MD
- Ramon Ramirez Ronda MD
- San Juan AIDS Program
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00004852
Brief Title
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
2. Study Status
Record Verification Date
August 2000
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Glaxo Wellcome
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV-1, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, Lamivudine, Genotype, Phenotype, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, efavirenz
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Efavirenz
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Zidovudine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Phoenix Body Positive
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Pacific Oaks Research
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
900276069
Country
United States
Facility Name
Tower ID Med Associates
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Davies Med Ctr / c/o HIV Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94114
Country
United States
Facility Name
Kaiser Foundation Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Harbor - UCLA Med Ctr
City
Torrance
State/Province
California
ZIP/Postal Code
90509
Country
United States
Facility Name
Georgetown Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
George Washington Univ Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Bach and Godofsky
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
TheraFirst Med Ctrs Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
The Coleman Institute Inc
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
The Coleman Institute Inc
City
Fort Pierce
State/Province
Florida
ZIP/Postal Code
34950
Country
United States
Facility Name
Kaiser Permanente Infectious Diseases
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30339
Country
United States
Facility Name
AIDS Research Alliance - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
Infectious Disease of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46218
Country
United States
Facility Name
Univ of Kentucky Med Ctr
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Tulane Univ School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Boston Med Ctr / Evans - 556
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021182393
Country
United States
Facility Name
Antibiotic Research Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
East Orange Veterans Administration Med Ctr
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018
Country
United States
Facility Name
ID Care Inc
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
ID Care Inc
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
ID Care Inc
City
Randolph
State/Province
New Jersey
ZIP/Postal Code
07869
Country
United States
Facility Name
ID Care Inc
City
Somerville
State/Province
New Jersey
ZIP/Postal Code
08876
Country
United States
Facility Name
Albany Med College / Div of HIV Medicine
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
North Shore Univ Hosp / Div of Infectious Diseases
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
St Vincents Hosp / Clinical Research Program
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
St Lukes / Roosevelt Hosp / HIV Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Ohio State Univ Hosp Clinic
City
Columbus
State/Province
Ohio
ZIP/Postal Code
432101228
Country
United States
Facility Name
Oklahoma State University / College of Osteopathic Medicine
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74107
Country
United States
Facility Name
Associates in Med and Mental Health
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74114
Country
United States
Facility Name
Miriam Hosp / Brown Univ
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Methodist Healthcare
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Univ of Tennessee
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Dr David Donnell
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Nelson-Tebedo Community Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75219
Country
United States
Facility Name
Univ of Texas Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Montrose Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77006
Country
United States
Facility Name
Baylor College of Medicine / Dept of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
770303498
Country
United States
Facility Name
Univ of Texas / Med School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univ of Texas Health Sciences Ctr
City
San Antonio
State/Province
Texas
ZIP/Postal Code
782847838
Country
United States
Facility Name
Hampton Roads Med Specialists
City
Hampton
State/Province
Virginia
ZIP/Postal Code
23666
Country
United States
Facility Name
Hosp Muniz
City
Buenos Aires
Country
Argentina
Facility Name
CAICI
City
Rosario - Santa Fe
Country
Argentina
Facility Name
Universidade de Campinas
City
Campinas - SP
Country
Brazil
Facility Name
Hosp Evandro Chagas Fioernz
City
Manguinhos RJ
Country
Brazil
Facility Name
Hosp Univ Clementino Fraga Filho
City
Rio de Janeiro - RJ
Country
Brazil
Facility Name
Hosp Univ Pedro Ernesto / Univ Estadual do RJ
City
Rio de Janeiro - RJ
Country
Brazil
Facility Name
Hosp Sao Paulo da Universidade Federal de Sao Paulo
City
Sao Paulo - SP
Country
Brazil
Facility Name
Southern Alberta HIV Clinic / Foothills Hosp
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Saint Paul's Hosp
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto Gen Hosp
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Wellesley/Central Site / St Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Clinique Medicale du Quartier Latin
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Clinique Medicale L'Actuele
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Ste Foy
State/Province
Quebec
Country
Canada
Facility Name
Caguas Regional Hosp
City
Caguas
ZIP/Postal Code
00726
Country
Puerto Rico
Facility Name
Hosp San Cristobal-Edif A
City
Cotto Laurel
ZIP/Postal Code
00780
Country
Puerto Rico
Facility Name
Carlos Leon-Valiente MD
City
Guaynabo
ZIP/Postal Code
00966
Country
Puerto Rico
Facility Name
Ramon Ramirez Ronda MD
City
Mayaguez
ZIP/Postal Code
00680
Country
Puerto Rico
Facility Name
San Juan AIDS Program
City
Santurce
ZIP/Postal Code
00908
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this 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
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