A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs
A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects
2 other identifiers
interventional
N/A
1 country
32
Brief Summary
The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 1998
32 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, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 1999
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 1999
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedApril 25, 2011
April 1, 2011
1.5 years
November 2, 1999
April 13, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- Within 15 business days prior to randomization:
- CD4 cell count greater than or equal to 100 cells/mm3.
- HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay.
You may not qualify if:
- Co-existing Condition:
- Patients with any of the following symptoms or conditions are excluded:
- Bilateral peripheral neuropathy.
- Intractable diarrhea.
- Proven or suspected acute hepatitis within 30 days prior to study entry.
- Concurrent Medication:
- Excluded:
- \- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
- Concurrent Treatment:
- Excluded:
- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
- Patients with the following prior conditions are excluded:
- History of acute or chronic pancreatitis.
- Prior Medication:
- Excluded:
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Sorra Research Ctr / Med Forum
Birmingham, Alabama, 35203, United States
Body Positive
Phoenix, Arizona, 85016, United States
Hill Top Research Inc
Fresno, California, 93710, United States
UCLA Med Ctr / CARE BH-412 CHS
Los Angeles, California, 90024, United States
AIDS Healthcare Foundation
Los Angeles, California, 900276069, United States
West Los Angeles VAMC
Los Angeles, California, 90073, United States
Sherman Oaks Hosp Research Institute
Sherman Oaks, California, 91403, United States
Harbor UCLA Med Ctr / Research and Educational Institute
Torrance, California, 90502, United States
Yale New Haven Hosp / Nathan Smith Clinic
New Haven, Connecticut, 06504, United States
GW Med Ctr / Clinical Trials Unit
Washington D.C., District of Columbia, 20037, United States
Med Alternatives
Fort Lauderdale, Florida, 33308, United States
Urgent Care Ctr
Fort Lauderdale, Florida, 33316, United States
Specialty Med Care Ctrs of South Florida Inc
Miami, Florida, 33142, United States
Hillsborough County Health Dept
Tampa, Florida, 33602, United States
Saint Josephs Hosp
Tampa, Florida, 33602, United States
Northwestern Univ / Div of Infect Diseases
Chicago, Illinois, 60611, United States
Rush Presbyterian / ST Lukes Med Ctr
Chicago, Illinois, 60612, United States
Univ of Kansas School of Medicine / Office of Rsch
Wichita, Kansas, 67214, United States
Ky Clinic Annex #4 / Room 205E / Speed Sort #0284
Lexington, Kentucky, 405360226, United States
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, 03756, United States
NJCRI
Newark, New Jersey, 07103, United States
Infectious Disease Assoc of Central Jersey
Somerville, New Jersey, 08876, United States
UCT International
Farmingdale, New York, 11735, United States
St Luke Roosevelt Hosp
New York, New York, 10011, United States
St Mary's Hosp (Univ of Rochester/Infectious Diseases)
Rochester, New York, 14642, United States
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, 117948153, United States
Nalle Clinic / Clinical Research Dept
Charlotte, North Carolina, 28207, United States
Associates in Med and Mental Health
Tulsa, Oklahoma, 74114, United States
Stephen P Hauptman
Philadelphia, Pennsylvania, 19107, United States
Med Univ of South Carolina / Div of Infect Disease
Charleston, South Carolina, 29425, United States
Univ of Texas / Med Branch at Galveston
Galveston, Texas, 775550835, United States
Joseph C Gathe
Houston, Texas, 77004, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Start
March 1, 1998
Primary Completion
September 1, 1999
Study Completion
September 1, 1999
Last Updated
April 25, 2011
Record last verified: 2011-04