A Study to Compare Two Anti-HIV Drug Combinations That Include Amprenavir in HIV-Infected Patients Who Have Failed Anti-HIV Drug Combinations That Did Not Include Amprenavir
NCT ID: NCT00002423
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
100 participants
INTERVENTIONAL
1999-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Indinavir sulfate
Abacavir sulfate
Amprenavir
Nelfinavir mesylate
Lamivudine
Eligibility Criteria
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Inclusion Criteria
* Are HIV-positive.
* Are 13 years of age or older.
* Are currently taking anti-HIV drugs, 1 of which must be NFV or IDV, and have taken these same drugs for at least 12 weeks.
* In the last 16 weeks your viral load (level of HIV in the blood) dropped below 400 copies/ml and has since increased to at least 1,000 copies/ml, even though you continue to take your anti-HIV drugs.
* Have the written consent of a parent or legal guardian if you are under age 18.
* Agree to practice abstinence or use effective barrier methods of birth control (unless you are physically incapable of becoming pregnant).
* Are willing to complete the 48-week study.
Exclusion Criteria
* Have ever taken the following anti-HIV drugs: ABC, APV, efavirenz (EFV), delavirdine (DLV), nevirapine (NVP), or loviride.
* Have certain AIDS-related infections or diseases, have other serious medical conditions such as diabetes and certain types of heart trouble, or have a history of lymphoma.
* Have had certain types of hepatitis in the past 6 months.
* Have received an HIV vaccine in the past 3 months or a flu vaccine in the past 30 days.
* Have certain digestion problems that make it difficult to take anti-HIV drugs by mouth.
* Have received certain other drugs or treatments in the past 30 days, or will need certain drugs or treatments during the study.
13 Years
ALL
No
Sponsors
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Glaxo Wellcome
INDUSTRY
Locations
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Saint Francis Mem Hosp
San Francisco, California, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, United States
IDC Research Initiative
Altamonte Springs, Florida, United States
Natl Institute of Allergy and Infectious Diseases
Bethesda, Maryland, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States
Bentley-Salick Med Practice
New York, New York, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Countries
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Other Identifiers
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PRO20005
Identifier Type: -
Identifier Source: secondary_id
264M
Identifier Type: -
Identifier Source: org_study_id