A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: January 17, 2000
Last updated: June 23, 2005
Last Verified: February 2000
History of Changes
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).
Drug : L-756423
Drug : Indinavir sulfate
Primary Purpose: Treatment
|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|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
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
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).
You will not be eligible for this study if you:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002452
Locations Show More
|United States, Alabama|
|Univ of Alabama at Birmingham|
|Birmingham, Alabama, United States, 352942050|
|United States, District of Columbia|
|Washington, District of Columbia, United States, 20007|
|United States, Georgia|
|AIDS Research Consortium of Atlanta|
|Atlanta, Georgia, United States, 30308|
|United States, Hawaii|
|Hawaii AIDS Clinical Trial Unit|
|Honolulu, Hawaii, United States, 96816|
|United States, Illinois|
|The CORE Ctr|
|Chicago, Illinois, United States, 60612|
|United States, New York|
|Cornell Clinical Trials Unit - Chelsea Clinic|
|New York, New York, United States, 10011|
|United States, Pennsylvania|
|Pittsburgh Treatment Ctr / Univ of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|United States, Tennessee|
|Vanderbilt Univ Med Ctr|
|Nashville, Tennessee, United States, 37203|
Sponsors and CollaboratorsMerck Sharp & Dohme Corp.
|Responsible Party:||Merck Sharp & Dohme Corp.|
|ClinicalTrials.gov Identifier:||NCT00002452 History of Changes|
|Other Study ID Numbers:||300A|
|Study First Received:||January 17, 2000|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:Drug Therapy, Combination
HIV Protease Inhibitors
Reverse Transcriptase Inhibitors
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on September 21, 2018
This information is provided by ClinicalTrials.gov.