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
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: December 1999
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.
Drug: Indinavir sulfate
Drug: Abacavir sulfate
Drug: Nelfinavir mesylate
||Endpoint Classification: Safety Study
Primary Purpose: Treatment
||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
| Estimated Enrollment:
| Study Start Date:
Patients experiencing virologic failure while receiving an IDV-containing antiretroviral regimen will receive the 3TC/ABC/APV/NFV combination. Patients experiencing virologic failure while receiving an NFV-containing antiretroviral regimen will receive the 3TC/ABC/APV/IDV combination.
|Ages Eligible for Study:
||13 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002423
|Saint Francis Mem Hosp
|San Francisco, California, United States, 94109 |
|Georgetown Univ Med Ctr
|Washington, District of Columbia, United States, 20007 |
|IDC Research Initiative
|Altamonte Springs, Florida, United States, 32701 |
|Natl Institute of Allergy and Infectious Diseases
|Bethesda, Maryland, United States, 20892 |
|Kansas City AIDS Research Consortium
|Kansas City, Missouri, United States, 64111 |
|Bentley-Salick Med Practice
|New York, New York, United States, 10011 |
|Associates in Med and Mental Health
|Tulsa, Oklahoma, United States, 74114 |
|Portland Veterans Adm Med Ctr / Rsch & Education Grp
|Portland, Oregon, United States, 972109951 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 31, 2015
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action