A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine
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: L-756423 (Drug); Indinavir sulfate (Drug); Lamivudine (Drug); Stavudine (Drug)
Phase: Phase 2
Status: Suspended
Sponsored by: Merck
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.
Clinical Details
Official title: 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
Study design: Treatment, Double-Blind, Safety Study
Detailed description:
Patients are randomized to 1 of 4 treatment arms. In Group 1, patients receive a dose of
L-756423/IDV once daily plus IDV placebo. In Group 3, patients receive a lower dose of
L-756423/IDV twice daily (with the daily dosage equaling that of Group 1) plus IDV placebo.
In Groups 2 and 4, patients receive equal dosages of IDV plus L-756423/IDV placebo. In all 4
groups L-756423 and IDV are blinded to the investigator and patient. All groups receive
open-label d4T and 3TC. Patients routinely undergo a physical exam and have blood and urine
tests to ensure the drugs' safety and tolerability, which will be evaluated by tabulation of
adverse events and clinical assessment of laboratory data. In addition, CD4+ T cell and
plasma viral RNA levels are measured to quantify the drugs' antiretroviral activity.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
You may not be eligible for this trial if you:
- Have ever taken anti-HIV drugs.
Locations and Contacts
UCLA School of Medicine / Ctr for Research and Education, Los Angeles, California 900951793, United States
Georgetown Univ Med Ctr, Washington, District of Columbia 20007, United States
ViRx / Dupont Circle Physicians Group, Washington, 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
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
NYU Med Ctr / C & D Building, New York, New York 10016, United States
The Miriam Hosp, Providence, Rhode Island 02906, United States
Additional Information
Last updated: June 23, 2005
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