Back to resultsA Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Indinavir sulfate
Nelfinavir mesylate
Lamivudine
Stavudine
Sponsored by
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir, Dosage Forms, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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.
Sites / Locations
- AIDS Healthcare Foundation
- Palo Alto Veterans Affairs Health Care System
- Dupont Circle Physicians Group
- IDC Research Initiative
- North Broward Hosp District
- Steinhart Medical Associates
- Northwestern Univ Med School
- Saint Vincents Hosp
- St Lukes - Roosevelt Hosp Ctr
- MCP Hahnemann Univ Hosp
- Southwest Infectious Disease Association / PA
- Univ TX Galveston Med Branch
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00002442
Brief Title
A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2000
Overall Recruitment Status
Completed
Study Start Date
June 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 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.
Detailed Description
Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Drug Therapy, Combination, Zidovudine, Drug Administration Schedule, Stavudine, HIV Protease Inhibitors, Lamivudine, Indinavir, Dosage Forms, Nelfinavir, Reverse Transcriptase Inhibitors, Anti-HIV Agents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Indinavir sulfate
Intervention Type
Drug
Intervention Name(s)
Nelfinavir mesylate
Intervention Type
Drug
Intervention Name(s)
Lamivudine
Intervention Type
Drug
Intervention Name(s)
Stavudine
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 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.
Exclusion Criteria
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.
Facility Information:
Facility Name
AIDS Healthcare Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Palo Alto Veterans Affairs Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Dupont Circle Physicians Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200091104
Country
United States
Facility Name
IDC Research Initiative
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Steinhart Medical Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Saint Vincents Hosp
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
St Lukes - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
MCP Hahnemann Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Southwest Infectious Disease Association / PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Facility Name
Univ TX Galveston Med Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
12. IPD Sharing Statement
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A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
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