Summary

for people ages 18 years and up (full criteria)
at UCLA
study started

Description

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.

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

Details

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.

Keywords

HIV Infections Drug Therapy, Combination Drug Administration Schedule Stavudine HIV Protease Inhibitors Lamivudine Indinavir Reverse Transcriptase Inhibitors Anti-HIV Agents L-756423 Indinavir sulfate

Eligibility

You can join if…

Open to people ages 18 years and up

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.

You CAN'T join if...

You may not be eligible for this trial if you:

  • Have ever taken anti-HIV drugs.

Locations

  • UCLA School of Medicine / Ctr for Research and Education
    Los Angeles California 900951793 United States
  • Rush Presbyterian - Saint Luke's Med Ctr
    Chicago Illinois 60612 United States
  • The CORE Ctr
    Chicago Illinois 60612 United States

Details

Status
currently not accepting new patients, but might later
Start Date
Sponsor
Merck Sharp & Dohme Corp.
ID
NCT00002424
Phase
Phase 2
Study Type
Interventional
Last Updated