A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine

This study has suspended participant recruitment.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002424
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 2000

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002424 on ClinicalTrials.gov Archive Site
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A Study to Compare the Safety and Effectiveness of Indinavir Combined With Stavudine and Lamivudine
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
  • Drug: L-756423
  • Drug: Indinavir sulfate
  • Drug: Lamivudine
  • Drug: Stavudine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
186
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002424
300B, 009-01, 009-00
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Merck Sharp & Dohme Corp.
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NIH AIDS Clinical Trials Information Service
April 2000

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