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
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Indinavir sulfate (Drug); Lamivudine (Drug); Stavudine (Drug); Zidovudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck
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.
Clinical Details
Official title: 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
Study design: Treatment, Pharmacokinetics Study
Detailed description:
Patients are randomized to 1 of 2 arms:
Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T
may be substituted for zidovudine for toxicity management. Patients are stratified based on
prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine [ddI],
dideoxycytidine [ddC], and d4T) and screening viral RNA results (lower than 50,000 copies/mL
vs more than 50,000 copies/mL).
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
Prior Medication:
Excluded:
- Prior therapy with protease inhibitors.
- Prior therapy with 3TC.
Locations and Contacts
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, 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
Additional Information
Related publications: 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. 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.
Last updated: June 23, 2005
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