A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC

June 23, 2005 updated by: Merck Sharp & Dohme LLC
To demonstrate that the antiviral activity and safety/tolerability of a test regimen of indinavir is equivalent to that of a control regimen of indinavir when each is coadministered with zidovudine (ZDV) (or stavudine, d4T) and lamivudine (3TC) for 24 weeks to protease inhibitor- and 3TC-naive HIV-1-seropositive patients. To characterize the steady-state pharmacokinetic profiles of indinavir, ZDV (or d4T), and 3TC in the presence of each other, for both the control and test regimen groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to 1 of 2 arms:

Arm A: Indinavir plus ZDV plus 3TC. Arm B: Indinavir (test dose) plus ZDV plus 3TC. NOTE: d4T may be substituted for zidovudine for toxicity management. Patients are stratified based on prior use of nucleoside analogs (naive vs experienced to ZDV, dideoxyinosine [ddI], dideoxycytidine [ddC], and d4T) and screening viral RNA results (lower than 50,000 copies/mL vs more than 50,000 copies/mL).

Study Type

Interventional

Enrollment

400

Phase

  • Phase 3

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
    • Alabama
      • Birmingham, Alabama, United States, 352942050
        • Univ of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90033
        • LAC/USC Med Ctr
      • San Francisco, California, United States, 94110
        • Kaiser Med Ctr
    • Delaware
      • Wilmington, Delaware, United States, 19899
        • Wilmington Hosp / Med Ctr of Delaware
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown Univ Med Ctr
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hosp
    • Missouri
      • St. Louis, Missouri, United States, 63108
        • Washington Univ
    • New York
      • Stony Brook, New York, United States, 117948153
        • Univ Hosp / SUNY at Stony Brook / AIDS TMT Unit
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19129
        • Allegheny Univ Hosp
      • Pittsburgh, Pennsylvania, United States, 15261
        • Pittsburgh Treatment Ctr / Univ of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Brown Univ / Miriam Hosp
    • Tennessee
      • Nashville, Tennessee, United States, 372321302
        • Vanderbilt Univ Med Ctr
    • Washington
      • Seattle, Washington, United States, 98104
        • Univ of Washington / AIDS Clinical Trial Unit

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have:

  • HIV-1 seropositive status.
  • CD4 count greater than 100 cells/mm3.
  • Viral RNA above 10,000 copies/mL.
  • Consent from parent or guardian if less than 18 years of age.

Exclusion Criteria

Prior Medication:

Excluded:

  • Prior therapy with protease inhibitors.
  • Prior therapy with 3TC.

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

Collaborators and Investigators

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

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 246M
  • 069-00

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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