A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
A Multicenter, Open-Label, Pilot Study to Evaluate the Safety and Activity of L-756423/Indinavir Sulfate, 800/400 Mg b.i.d. in Combination With Two nRTIs in HIV-Infected Patients Who Failed an Indinavir Containing Regimen
2 other identifiers
interventional
30
1 country
8
Brief Summary
The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 hiv-infections
8 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
January 17, 2000
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
February 1, 2000
January 17, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this study if you:
- Are HIV-positive.
- Are at least 18 years old.
- Have a viral load of at least 1,000 copies/ml.
- Have a CD4 cell count of at least 100 cells/mm3.
- Have experienced treatment failure (your viral load increased significantly) within 24 weeks of study entry while taking indinavir.
You may not qualify if:
- You will not be eligible for this study if you:
- Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050, United States
Georgetown Univ
Washington D.C., District of Columbia, 20007, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Hawaii AIDS Clinical Trial Unit
Honolulu, Hawaii, 96816, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Cornell Clinical Trials Unit - Chelsea Clinic
New York, New York, 10011, United States
Pittsburgh Treatment Ctr / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 17, 2000
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 2000-02