A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002452
First received: January 17, 2000
Last updated: June 23, 2005
Last verified: February 2000

January 17, 2000
June 23, 2005
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Complete list of historical versions of study NCT00002452 on ClinicalTrials.gov Archive Site
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A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
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

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).

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Primary Purpose: Treatment
HIV Infections
  • Drug: L-756423
  • Drug: Indinavir sulfate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
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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).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002452
300A, 008-00
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Merck Sharp & Dohme Corp.
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NIH AIDS Clinical Trials Information Service
February 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP