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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 1999

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2001

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2005

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2005

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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