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

June 23, 2005 updated by: Merck Sharp & Dohme LLC

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment

186

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 900951793
        • UCLA School of Medicine / Ctr for Research and Education
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
      • Washington, District of Columbia, United States, 20009
        • ViRx / Dupont Circle Physicians Group
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Associates in Research
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Grady Mem Hosp
    • Illinois
      • Chicago, Illinois, United States, 60612
        • The CORE Ctr
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Univ of Kentucky Med Ctr
      • Lexington, Kentucky, United States, 40536
        • Univ of Kentucky
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Med Ctr
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hosp
    • New York
      • New York, New York, United States, 10021
        • Aaron Diamond AIDS Rsch Ctr / Rockefeller Univ
      • New York, New York, United States, 10016
        • NYU Med Ctr / C & D Building
      • Stony Brook, New York, United States, 117948153
        • SUNY at Stony Brook / Div of Infectious Disease
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hosp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

April 1, 2000

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300B
  • 009-01
  • 009-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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