A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations
A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals
3 other identifiers
interventional
220
1 country
46
Brief Summary
The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable hiv-infections
46 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
CompletedJune 24, 2005
February 1, 2000
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this study if you:
- Are HIV positive.
- Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry.
- Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry.
- Have a normal chest X-ray.
- Have never taken protease inhibitors or 3TC.
- Are 16 years of age or older.
- Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms).
You may not qualify if:
- You will not be eligible for this study if you:
- Have an active opportunistic (AIDS-related) infection or cancer.
- Have certain types of Kaposi's sarcoma.
- Have hepatitis.
- Have chronic diarrhea.
- Have a history of certain medical conditions.
- Are allergic to any of the study medications.
- Are taking certain medications.
- Are pregnant or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Univ of Alabama School of Med
Montgomery, Alabama, 36116, United States
Ocean View Internal Medicine
Long Beach, California, 90803, United States
AIDS Healthcare Foundation
Los Angeles, California, 90027, United States
Tower ID Med Associates
Los Angeles, California, 90048, United States
Oasis Clinic / King Drew Med Ctr
Los Angeles, California, 90059, United States
Robert Scott MD
Oakland, California, 94609, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
Saint Francis Mem Hosp / HIV Care Unit
San Francisco, California, 94109, United States
Pacific Horizons Med Group
San Francisco, California, 94115, United States
Kaiser Foundation Hospital
San Francisco, California, 94118, United States
Harbor - UCLA Med Ctr
Torrance, California, 90502, United States
Denver Public Health Dept
Denver, Colorado, 80204, United States
Blick Med Associates
Stamford, Connecticut, 06901, United States
Physicans Home Service
Washington D.C., District of Columbia, 20037, United States
IDC Research Initiative
Altamonte Springs, Florida, 32701, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Hillsborough County Health Dept
Tampa, Florida, 33602, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Harold Katner MD
Macon, Georgia, 31202, United States
Thomas Coffman MD
Boise, Idaho, 83712, United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610, United States
Northwestern Univ Med Ctr
Chicago, Illinois, 60611, United States
Univ of Illinois
Chicago, Illinois, 60612, United States
Kentucky Clinical Research
Lexington, Kentucky, 40504, United States
Louisiana State Univ Med Ctr / Tulane Med School
New Orleans, Louisiana, 70112, United States
AIDS Consultation Service / Maine Med Ctr
Portland, Maine, 04102, United States
Institute of Human Virology
Baltimore, Maryland, 21201, United States
JSI Research and Training Institute
Boston, Massachusetts, 02210, United States
Education & Research Building
Camden, New Jersey, 08103, United States
NJCRI
Newark, New Jersey, 07103, United States
Infectious Disease Specialists of NJ
Union, New Jersey, 07083, United States
Brookdale Univ Hosp and Med Ctr
Brooklyn, New York, 112123198, United States
Liberty Med Group
New York, New York, 10016, United States
James Jones MD
New York, New York, 10019, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Community Health Network
Rochester, New York, 14620, United States
Wake Forest Univ School of Medicine
Winston-Salem, North Carolina, 27157, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114, United States
The Research and Education Group
Portland, Oregon, 97210, United States
Fanno Creek Clinic
Portland, Oregon, 97219, United States
Anderson Clinical Research / Inc
Pittsburgh, Pennsylvania, 15213, United States
Burnside Clinic
Columbia, South Carolina, 29206, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
Oak Lawn Physicians Group
Dallas, Texas, 75219, United States
Univ TX Galveston Med Branch
Galveston, Texas, 77555, United States
Infections Ltd / Physicians Med Ctr
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2000-02