HIV InfectionsPhase 2NCT00004852
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
A Phase 2 study testing Efavirenz, Lamivudine and Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 66 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- Efavirenz, Lamivudine and Zidovudine
- How many people
- Not given
- Where
- 66 sitesin 5 countries
- Study dates
- Sep 1999to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
66 sites in 5 countries.
66 sites in 5 countries
United States46 sites
Albany Med College / Div of HIV Medicine
Albany, New York, 12208
IDC Research Initiative
Altamonte Springs, Florida, 32701
Kaiser Permanente Infectious Diseases
Atlanta, Georgia, 30339
Pacific Oaks Research
Beverly Hills, California, 90211
Boston Med Ctr / Evans - 556
Boston, Massachusetts, 021182393
Bach and Godofsky
Bradenton, Florida, 34205
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Dr David Donnell
Dallas, Texas, 75219
Nelson-Tebedo Community Clinic
Dallas, Texas, 75219
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308
North Broward Hosp District
Fort Lauderdale, Florida, 33316
The Coleman Institute Inc
Fort Lauderdale, Florida, 33334
The Coleman Institute Inc
Ft. Pierce, Florida, 34950
Univ of Texas Med Branch
Galveston, Texas, 77555
Hampton Roads Med Specialists
Hampton, Virginia, 23666
Montrose Clinic
Houston, Texas, 77006
Baylor College of Medicine / Dept of Medicine
Houston, Texas, 770303498
Univ of Texas / Med School at Houston
Houston, Texas, 77030
Infectious Disease of Indiana
Indianapolis, Indiana, 46218
Antibiotic Research Associates
Kansas City, Missouri, 64132
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536
AIDS Healthcare Foundation
Los Angeles, California, 900276069
Tower ID Med Associates
Los Angeles, California, 90048
North Shore Univ Hosp / Div of Infectious Diseases
Manhasset, New York, 11030
Methodist Healthcare
Memphis, Tennessee, 38104
Univ of Tennessee
Memphis, Tennessee, 38163
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203
ID Care Inc
New Brunswick, New Jersey, 08901
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
St Vincents Hosp / Clinical Research Program
New York, New York, 10011
St Lukes / Roosevelt Hosp / HIV Center
New York, New York, 10019
Phoenix Body Positive
Phoenix, Arizona, 85016
ID Care Inc
Princeton, New Jersey, 08540
Miriam Hosp / Brown Univ
Providence, Rhode Island, 02906
ID Care Inc
Randolph Township, New Jersey, 07869
Univ of Texas Health Sciences Ctr
San Antonio, Texas, 782847838
Davies Med Ctr / c/o HIV Institute
San Francisco, California, 94114
Kaiser Foundation Hospital
San Francisco, California, 94118
ID Care Inc
Somerville, New Jersey, 08876
Harbor - UCLA Med Ctr
Torrance, California, 90509
Oklahoma State University / College of Osteopathic Medicine
Tulsa, Oklahoma, 74107
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037
Canada8 sites
Southern Alberta HIV Clinic / Foothills Hosp
Calgary, Alberta
Clinique Medicale du Quartier Latin
Montreal, Quebec
Clinique Medicale L'Actuele
Montreal, Quebec
Centre Hospitalier Universitaire de Quebec
Ste Foy, Quebec
Sunnybrook Health Science Centre
Toronto, Ontario
Toronto Gen Hosp
Toronto, Ontario
Wellesley/Central Site / St Michael's Hospital
Toronto, Ontario
Saint Paul's Hosp
Vancouver, British Columbia
Brazil5 sites
Universidade de Campinas
Campinas - SP
Hosp Evandro Chagas Fioernz
Manguinhos RJ
Hosp Univ Clementino Fraga Filho
Rio de Janeiro - RJ
Hosp Univ Pedro Ernesto / Univ Estadual do RJ
Rio de Janeiro - RJ
Hosp Sao Paulo da Universidade Federal de Sao Paulo
Sao Paulo - SP
Puerto Rico5 sites
Caguas Regional Hosp
Caguas, 00726
Hosp San Cristobal-Edif A
Cotto Laurel, 00780
Carlos Leon-Valiente MD
Guaynabo, 00966
Ramon Ramirez Ronda MD
Mayagüez, 00680
San Juan AIDS Program
Santurce, 00908
About this 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
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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Efavirenz, Lamivudine, Zidovudine
- Keywords
- HIV-1, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, Lamivudine, Genotype, Phenotype, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Viral Load, efavirenz
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfavirenzDrug
LamivudineDrug
ZidovudineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study startSep 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Glaxo Wellcome
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004852
- Sponsor's protocol ID
- 225D
- Other IDs
- EPV2000 1
- Status last verified
- Aug 2000
- First submitted
- 2 Mar 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00004852
- Acronym / sponsor ID
- 225D
- Conditions
- HIV Infections
- Keywords
- HIV-1, Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, Lamivudine, Genotype, Phenotype, Reverse Transcriptase Inhibitors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Glaxo WellcomeIndustry (pharma, biotech, devices)
- Study start
- Sep 1999
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Efavirenz | Drug | – |
| Lamivudine | Drug | – |
| Zidovudine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
66 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Efavirenz, Lamivudine and Zidovudine in people with HIV Infections, run by Glaxo Wellcome at 66 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Canada, Brazil, Puerto Rico, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.