A Study to Compare The Ability of Different Anti-HIV Drugs to Decrease Viral Load After Nelfinavir (an Anti-HIV Drug)Treatment Failure
A Phase II, Randomized, Open-Label Comparative Trial of Salvage Antiretroviral Therapies for HIV-Infected Individuals With Virological Evidence of Nelfinavir Treatment Failure as Reflected by Plasma HIV RNA Concentration of >= 1,000 Copies/ml
4 other identifiers
interventional
300
2 countries
39
Brief Summary
The purpose of this study is to determine the safety and effectiveness of combining several anti-HIV drugs in order to decrease plasma viral load (level of HIV in the blood) in HIV-positive patients who have failed nelfinavir (NFV) treatment. In order to determine the ability of a drug regimen to decrease viral load after drug treatment has failed, it is best to test a variety different of drug "cocktails" (drug regimens). The drug cocktails in this study include 2 new nucleoside reverse transcriptase inhibitors (NRTIs), efavirenz (an NNRTI, non-nucleoside reverse transcriptase inhibitor), and either 1 or 2 protease inhibitors. It is important to include multiple drugs from different groups in a drug cocktail since combinations containing fewer drugs are likely to fail.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hiv-infections
39 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
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2002
CompletedMay 21, 2012
May 1, 2012
November 2, 1999
May 17, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients may be eligible for this study if they:
- Are over 13 years old (need consent of parent or guardian if under 18).
- Are HIV-positive.
- Currently have virologic failure (more than 1,000 copies of HIV RNA per ml).
- Agree to abstinence or use of effective birth control during the study.
- Have been taking NFV for the past 12 weeks.
You may not qualify if:
- Patients will not be eligible for this study if they:
- Have a fever for 7 days or diarrhea for 30 days before study entry.
- Have a history of peripheral neuropathy within 60 days of study entry.
- Have hepatitis.
- Have any malignancy (cancer) other than minimal Kaposi's sarcoma.
- Are pregnant or breast-feeding.
- Are receiving radiation, chemotherapy, or any therapy for any illness within 14 days of study entry.
- Have taken amprenavir, saquinavir, indinavir or ritonavir for more than 7 days.
- Have received an HIV vaccine 30 days before study entry.
- Are receiving certain other medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Willow Clinic
Menlo Park, California, 94025, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699, United States
Marin County Specialty Clinic
San Rafael, California, 94903, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Howard Univ
Washington D.C., District of Columbia, 20059, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Methodist Hosp of Indiana / Life Care Clinic
Indianapolis, Indiana, 46202, United States
Harvard (Massachusetts Gen Hosp)
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Chelsea Ctr
New York, New York, 10021, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of Rochester Medical Center
Rochester, New York, 14642, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Duke Univ Med Ctr
Durham, North Carolina, 27710, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Washington
Seattle, Washington, 98104, United States
Univ of Puerto Rico
San Juan, 009365067, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
John Mellors; William Powderly
- STUDY CHAIR
Scott Hammer