A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine
A Multicenter, Double-Blind, Randomized Pilot Study to Compare the Safety and Activity of L-756423/Indinavir, 1600/800 Mg Qd or 800/400 Mg Bid Versus Indinavir, 800 Mg q8h, All in Combination With Stavudine and Lamivudine
3 other identifiers
interventional
186
1 country
16
Brief Summary
This study will see how safe and effective against HIV the drugs L-756423 plus indinavir (IDV) are compared to just IDV when taken with stavudine (d4T) and lamivudine (3TC). The study will also see whether taking 1 large dose of L-756423/IDV once a day is as safe and effective as taking 2 smaller doses twice a day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
16 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
April 1, 2000
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- You may be eligible for this trial if you:
- Have HIV infection.
- Have levels of CD4 cells of 100 cells/mm3 or greater.
- Have a viral load of 10,000 copies/ml or greater.
- Are 18 years of age or older.
You may not qualify if:
- You may not be eligible for this trial if you:
- Have ever taken anti-HIV drugs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
UCLA School of Medicine / Ctr for Research and Education
Los Angeles, California, 900951793, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
ViRx / Dupont Circle Physicians Group
Washington D.C., District of Columbia, 20009, United States
Associates in Research
Fort Myers, Florida, 33901, United States
Univ of Miami School of Medicine
Miami, Florida, 33136, United States
Grady Mem Hosp
Atlanta, Georgia, 30308, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
The CORE Ctr
Chicago, Illinois, 60612, United States
Univ of Kentucky Med Ctr
Lexington, Kentucky, 40536, United States
Univ of Kentucky
Lexington, Kentucky, 40536, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215, United States
Henry Ford Hosp
Detroit, Michigan, 48202, United States
NYU Med Ctr / C & D Building
New York, New York, 10016, United States
Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
New York, New York, 10021, United States
SUNY at Stony Brook / Div of Infectious Disease
Stony Brook, New York, 117948153, United States
The Miriam Hosp
Providence, Rhode Island, 02906, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- DOUBLE
- 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: 2000-04