A Study to Compare the Effectiveness of Two Anti-HIV Drug Combinations

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

A Multicenter, Open-Label, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate/d4T/3TC Versus Indinavir Sulfate/Nelfinavir Mesylate/d4T/3TC in HIV-Infected Individuals

The purpose of this study is to compare two different anti-HIV drug combinations, one that contains nelfinavir (NFV) and one that does not. The best dosing schedule for indinavir (IDV) also will be studied.

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.

Detailed Description

Patients are stratified by screening plasma viral RNA results (50,000 copies/ml or below vs above 50,000 copies/ml) and randomized to 1 of 2 treatment arms. Group 1 receives IDV 3 times daily plus d4T/3TC twice daily. Group 2 receives IDV/NFV/d4T/3TC twice daily. Patients remain on study medications for 24 weeks and are seen at the clinic once every 4 weeks after entering the study. At each clinic visit, blood samples are taken to evaluate CD4 cell count and plasma HIV RNA levels.

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

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

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.
  • Not Applicable

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
      • Montgomery, Alabama, United States, 36116
        • Univ of Alabama School of Med
    • California
      • Long Beach, California, United States, 90803
        • Ocean View Internal Medicine
      • Los Angeles, California, United States, 90027
        • Aids Healthcare Foundation
      • Los Angeles, California, United States, 90059
        • Oasis Clinic / King Drew Med Ctr
      • Los Angeles, California, United States, 90048
        • Tower ID Med Associates
      • Oakland, California, United States, 94609
        • Robert Scott MD
      • Redwood City, California, United States, 94063
        • AIDS Community Research Consortium
      • San Francisco, California, United States, 94115
        • Pacific Horizons Med Group
      • San Francisco, California, United States, 94118
        • Kaiser Foundation Hospital
      • San Francisco, California, United States, 94109
        • Saint Francis Mem Hosp / HIV Care Unit
      • Torrance, California, United States, 90502
        • Harbor - UCLA Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver Public Health Dept
    • Connecticut
      • Stamford, Connecticut, United States, 06901
        • Blick Med Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • Physicans Home Service
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • IDC Research Initiative
      • Miami, Florida, United States, 33136
        • Univ of Miami School of Medicine
      • Tampa, Florida, United States, 33602
        • Hillsborough County Health Dept
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory Univ
      • Macon, Georgia, United States, 31202
        • Harold Katner MD
    • Idaho
      • Boise, Idaho, United States, 83712
        • Thomas Coffman MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Univ Med Ctr
      • Chicago, Illinois, United States, 60610
        • Chicago Ctr for Clinical Research
      • Chicago, Illinois, United States, 60612
        • Univ of Illinois
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Kentucky Clinical Research
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State Univ Med Ctr / Tulane Med School
    • Maine
      • Portland, Maine, United States, 04102
        • AIDS Consultation Service / Maine Med Ctr
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Institute of Human Virology
    • Massachusetts
      • Boston, Massachusetts, United States, 02210
        • JSI Research and Training Institute
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Education & Research Building
      • Newark, New Jersey, United States, 07103
        • NJCRI
      • Union, New Jersey, United States, 07083
        • Infectious Disease Specialists of NJ
    • New York
      • Brooklyn, New York, United States, 112123198
        • Brookdale Univ Hosp and Med Ctr
      • New York, New York, United States, 10029
        • Mount Sinai Med Ctr
      • New York, New York, United States, 10019
        • James Jones MD
      • New York, New York, United States, 10016
        • Liberty Med Group
      • Rochester, New York, United States, 14620
        • Community Health Network
    • North Carolina
      • Winston Salem, North Carolina, United States, 27157
        • Wake Forest Univ School of Medicine
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74114
        • Associates in Med and Mental Health
    • Oregon
      • Portland, Oregon, United States, 97219
        • Fanno Creek Clinic
      • Portland, Oregon, United States, 97210
        • The Research and Education Group
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Anderson Clinical Research / Inc
    • South Carolina
      • Columbia, South Carolina, United States, 29206
        • Burnside Clinic
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt Univ Med Ctr
    • Texas
      • Dallas, Texas, United States, 75219
        • Oak Lawn Physicians Group
      • Galveston, Texas, United States, 77555
        • Univ TX Galveston Med Branch
    • Washington
      • Tacoma, Washington, United States, 98405
        • Infections Ltd / Physicians Med Ctr

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

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

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV positive.
  • Have a viral load (level of HIV in your blood) of at least 10,000 copies/ml within 45 days of study entry.
  • Have a CD4 cell count of at least 100 cells/mm3 within 45 days of study entry.
  • Have a normal chest X-ray.
  • Have never taken protease inhibitors or 3TC.
  • Are 16 years of age or older.
  • Agree to practice sexual abstinence or use barrier methods of birth control (e.g., condoms).

Exclusion Criteria

You will not be eligible for this study if you:

  • Have an active opportunistic (AIDS-related) infection or cancer.
  • Have certain types of Kaposi's sarcoma.
  • Have hepatitis.
  • Have chronic diarrhea.
  • Have a history of certain medical conditions.
  • Are allergic to any of the study medications.
  • Are taking certain medications.
  • Are pregnant or breast-feeding.

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.
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

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.
February 1, 2000

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.
  • 246R
  • 079-02
  • CRX454

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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