A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs
NCT ID: NCT00002442
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
1999-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
NONE
Interventions
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Indinavir sulfate
Nelfinavir mesylate
Lamivudine
Stavudine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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AIDS Healthcare Foundation
Los Angeles, California, United States
Palo Alto Veterans Affairs Health Care System
Palo Alto, California, United States
Dupont Circle Physicians Group
Washington D.C., District of Columbia, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
North Broward Hosp District
Fort Lauderdale, Florida, United States
Steinhart Medical Associates
Miami, Florida, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Saint Vincents Hosp
New York, New York, United States
St Lukes - Roosevelt Hosp Ctr
New York, New York, United States
MCP Hahnemann Univ Hosp
Philadelphia, Pennsylvania, United States
Southwest Infectious Disease Association / PA
Dallas, Texas, United States
Univ TX Galveston Med Branch
Galveston, Texas, United States
Countries
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Other Identifiers
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COLA 4005
Identifier Type: -
Identifier Source: secondary_id
225C
Identifier Type: -
Identifier Source: org_study_id