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

Completed · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002423

Run by

Glaxo Wellcome

People needed

100

Starts

1999-03-01

Last updated by the study team

2005-06-24

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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