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
A Phase II, Open-Label Trial for Treatment of HIV Infection in Subjects Who Have Failed Initial Combination Therapy With Regimens Containing Indinavir or Nelfinavir: Combination Therapy With 3TC (150 Mg BID), Abacavir (300 Mg BID) and Amprenavir (1200 Mg BID) Plus Either Nelfinavir (1250 Mg BID) or Indinavir (800 Mg TID) for 48 Weeks
2 other identifiers
interventional
100
1 country
8
Brief Summary
This study will compare the safety and effectiveness of two anti-HIV drug combinations in fighting HIV infection in patients whose viral loads (levels of HIV in the blood) rose with other anti-HIV drug treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 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
December 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this trial if you:
- 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.
You may not qualify if:
- You will not be eligible for this trial if you:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (8)
Saint Francis Mem Hosp
San Francisco, California, 94109, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Natl Institute of Allergy and Infectious Diseases
Bethesda, Maryland, 20892, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, 64111, United States
Bentley-Salick Med Practice
New York, New York, 10011, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 972109951, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
March 1, 1999
Last Updated
June 24, 2005
Record last verified: 1999-12