A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 Mg BID Versus Epivir 300 Mg Once-Daily When Administered for 24 Weeks in Combination With FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects With HIV-1 Infection
2 other identifiers
interventional
N/A
1 country
12
Brief Summary
The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
12 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
August 1, 2000
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are HIV-positive.
- Are at least 18 years old.
- Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry.
- Have a CD4 cell count of at least 50 cells/mm3.
- Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.)
- Agree to abstain from sex or use effective methods of birth control during the study.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have a history of an AIDS-defining illness or certain other medical conditions.
- Are allergic to any of the study drugs.
- Are unable to take medication by mouth for any reason.
- Have received certain medications.
- Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (12)
AIDS Healthcare Foundation
Los Angeles, California, 90027, United States
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, 94304, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, 200091104, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
North Broward Hosp District
Fort Lauderdale, Florida, 33316, United States
Steinhart Medical Associates
Miami, Florida, 33133, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Saint Vincents Hosp
New York, New York, 10011, United States
St Lukes - Roosevelt Hosp Ctr
New York, New York, 10019, United States
MCP Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102, United States
Southwest Infectious Disease Association / PA
Dallas, Texas, 75225, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77550, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
June 1, 1999
Last Updated
June 24, 2005
Record last verified: 2000-08