A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
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)
Phase: Phase 2
Status: Completed
Sponsored by: Merck
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).
Clinical Details
Official title: 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
Study design: Treatment, Safety Study
Detailed description:
All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse
transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain
on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are
evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2,
4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6,
8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
You will not be eligible for this study if you:
- Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).
Locations and Contacts
Univ of Alabama at Birmingham, Birmingham, Alabama 352942050, United States
Georgetown Univ, Washington, 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
Additional Information
Last updated: June 23, 2005
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