A Study of Three Different Anti-HIV Drug Combinations in HIV-Infected Patients

June 23, 2005 updated by: Dupont Merck

A Phase III, Multicenter, Randomized, Open-Label Study to Compare Antiretroviral Activity and Tolerability of Three Different Combination Regimens (DMP 266 + Indinavir, DMP 266 + Zidovudine + Lamivudine, Indinavir + Zidovudine + Lamivudine) in HIV-Infected Patients

The purpose of this study is to compare the safety and effectiveness of three anti-HIV drug combinations. The three combinations are: (1) efavirenz (DMP 266) plus indinavir; (2) DMP 266 plus zidovudine (ZDV) plus lamivudine (3TC); and (3) indinavir plus ZDV plus 3TC. This study also examines the resistance HIV may have to these drugs and if these drugs are effective over a long period of time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Javier O Morales Ramirez
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Body Positive
      • Tucson, Arizona, United States, 85712
        • Arizona Clinical Research Ctr Inc
    • California
      • Beverly Hills, California, United States, 90210
        • Richard Stryker
      • Irvine, California, United States, 92618
        • Paul Cimoch
      • Los Angeles, California, United States, 90027
        • AIDS Healthcare Foundation
      • Los Angeles, California, United States, 90036
        • Kraus Med Group
      • Los Angeles, California, United States, 90059
        • Oasis Clinic / Martin Luther Jr Gen Hosp / King-Drew Med Ctr
    • Connecticut
      • Stamford, Connecticut, United States, 06901
        • Blick Med Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Novum Inc
    • Florida
      • Bradenton, Florida, United States, 34205
        • Bach and Godofsky
      • Coral Gables, Florida, United States, 33146
        • Community Research Initiative of South Florida
      • Jacksonville, Florida, United States, 32209
        • Boulevard Comprehensive Care Ctr
      • Lake Worth, Florida, United States, 33463
        • Larry Marc Bush / c/o Sally Yantis
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
      • Tampa, Florida, United States, 33609
        • Ctr for Quality Care
      • Tampa, Florida, United States, 33614
        • Infectious Disease Research Institute
      • Tampa, Florida, United States, 33614
        • Daniel Seekins
      • Vero Beach, Florida, United States, 32960
        • Treasure Coast Infectious Disease Consultants
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Georgia Research Associates
      • Augusta, Georgia, United States, 30912
        • Med College of Georgia
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Infectious Diseases
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Univ of Kentucky Med Ctr
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Kansas City AIDS Research Consortium
    • Nebraska
      • Omaha, Nebraska, United States, 681985400
        • Univ of Nebraska Med Ctr / HIV Clinic
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Univ Med Ctr / HIV Wellness Ctr
    • New York
      • New York, New York, United States, 10001
        • Community Research Initiative on AIDS
      • New York, New York, United States, 10011
        • Clinical Directors Network / HIV/AIDS Program Manager
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Wake Forest Univ School of Medicine
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Remington-Davis Inc
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Philadelphia FIGHT
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hosp
    • Texas
      • Dallas, Texas, United States, 75208
        • Research Services 2000 Inc
      • Dallas, Texas, United States, 752359113
        • Division of Infectious Disease / Dept of Internal Medicine
      • Fort Worth, Texas, United States, 76103
        • Research Services 2000 Inc
      • Houston, Texas, United States, 77006
        • Montrose Clinic
      • Houston, Texas, United States, 77030
        • UT-Health Science Ctr
      • San Antonio, Texas, United States, 78229
        • Diagnostic Clinic of San Antonio
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Oyster Point Med Specialists
    • Washington
      • Seattle, Washington, United States, 98122
        • Novum Inc / Pharmaceutical Research Services
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Infectious Diseases Associates

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

13 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Exclusion Criteria

Concurrent Medication:

Excluded:

  • Terfenadine, astemizole, cisapride, triazolam, or midazolam (competition for the enzyme cytochrome P-450 3A4 [CYP3A4] by indinavir could result in inhibition of metabolic breakdown of these drugs and create the potential for serious and/or life threatening events [i.e., cardiac arrhythmia, prolonged sedation]).
  • Rifampin or rifabutin (prohibited because of potential drug interaction with indinavir).
  • Ketoconazole, itraconazole, and clarithromycin.
  • Concomitant systemic therapy for acute opportunistic infection or malignancy.

Excluded:

Life expectancy less than 12 months.

Prior Medication:

Excluded:

  • Prior treatment with efavirenz, 3TC, an NNRTI, or an HIV protease inhibitor.
  • Prior antiretroviral agent within 14 days of initiating study treatment.
  • Prior treatment (within 30 days of initiating study treatment) with any other experimental drug for any indication.

Patients must:

  • Have a diagnosis of HIV infection.
  • Have CD4 counts greater than or equal to 50 cell/mm3.
  • Have a life expectancy greater than or equal to 12 months.
  • Be post-pubescent.

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

Dupont Merck

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

November 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 281B
  • DMP 266-006

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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