A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC
2 other identifiers
interventional
400
1 country
15
Brief Summary
To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 hiv-infections
15 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, 2003
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- HIV-1 seropositive status.
- CD4 count greater than 100 cells/mm3.
- Viral RNA above 10,000 copies/mL.
- Consent from parent or guardian if less than 18 years of age.
You may not qualify if:
- Prior Medication:
- Excluded:
- Prior therapy with protease inhibitors.
- Prior therapy with 3TC.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Univ of Alabama at Birmingham
Birmingham, Alabama, 352942050, United States
LAC/USC Med Ctr
Los Angeles, California, 90033, United States
Kaiser Med Ctr
San Francisco, California, 94110, United States
Wilmington Hosp / Med Ctr of Delaware
Wilmington, Delaware, 19899, United States
Georgetown Univ Med Ctr
Washington D.C., District of Columbia, 20007, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Cook County Hosp
Chicago, Illinois, 60612, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
Washington Univ
St Louis, Missouri, 63108, United States
Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
Stony Brook, New York, 117948153, United States
Allegheny Univ Hosp
Philadelphia, Pennsylvania, 19129, United States
Pittsburgh Treatment Ctr / Univ of Pittsburgh
Pittsburgh, Pennsylvania, 15261, United States
Brown Univ / Miriam Hosp
Providence, Rhode Island, 02906, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372321302, United States
Univ of Washington / AIDS Clinical Trial Unit
Seattle, Washington, 98104, United States
Related Publications (1)
Haas DW, Arathoon E, Thompson MA, de Jesus Pedro R, Gallant JE, Uip DE, Currier J, Noriega LM, Lewi DS, Uribe P, Benetucci L, Cahn P, Paar D, White AC Jr, Collier AC, Ramirez-Ronda CH, Harvey C, Chung MO, Mehrotra D, Chodakewitz J, Nguyen BY; Protocol 054/069 Study Teams. Comparative studies of two-times-daily versus three-times-daily indinavir in combination with zidovudine and lamivudine. AIDS. 2000 Sep 8;14(13):1973-8. doi: 10.1097/00002030-200009080-00013.
PMID: 10997402BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- 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: 2003-02