Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

April 13, 2011 updated by: Bristol-Myers Squibb

Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily

Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and hopefully will prevent stomach upset. The purpose of this study is to compare the effectiveness of ddI EC versus the standard form of ddI. Both forms of ddI will be given with stavudine (d4T) plus nelfinavir (NLF).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients are randomized to 1 of 2 open-label treatment groups. Group 1 receives ddI EC plus d4T plus NLF for 48 weeks. Group 2 receives ddI plus d4T plus NLF for 48 weeks. Both forms of ddI are administered orally once daily. Antiviral activity is determined by the magnitude and the duration of reduction of plasma HIV RNA from baseline through Week 24.

Study Type

Interventional

Enrollment

120

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique Medicale du Quartier Latin
      • Montreal, Quebec, Canada
        • Clinique Medicale L'Actuele
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35203
        • Sorra Research Ctr / Med Forum
    • California
      • Los Angeles, California, United States, 900276069
        • AIDS Healthcare Foundation
      • Oakland, California, United States, 94609
        • Robert Scott MD
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Beacon Clinic / Boulder Community Hosp
    • Florida
      • Fort Lauderdale, Florida, United States, 33306
        • Community Health Care
      • Fort Lauderdale, Florida, United States, 33316
        • HIV Clinical Research Ctr
      • Fort Lauderdale, Florida, United States, 33311
        • Immunity Care and Research Inc
      • Miami, Florida, United States, 33139
        • South Shore Hosp
      • Tampa, Florida, United States, 33607
        • Saint Josephs Comprehensive Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 303081962
        • AIDS Research Consortium of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Chicago Ctr for Clinical Research
    • Kansas
      • Wichita, Kansas, United States, 672143124
        • Univ of Kansas School of Medicine
    • Nebraska
      • Omaha, Nebraska, United States, 681985400
        • Univ of Nebraska Med Ctr
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Clinical Studies of Las Vegas
    • New York
      • Rego Park, New York, United States, 11374
        • Anderson Clinical Research Inc
    • Pennsylvania
      • Reading, Pennsylvania, United States, 19604
        • Anderson Clinical Research Inc
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Coastal Carolina Research Ctr
    • Texas
      • Dallas, Texas, United States, 75246
        • Nicholaos Bellos
      • Dallas, Texas, United States, 752359103
        • Univ of Texas Southwestern Med Ctr of Dallas
      • Dallas, Texas, United States, 75219
        • Oak Lawn Physicians Group
      • Houston, Texas, United States, 77006
        • Houston Clinical Research Network / Div of Montrose Clinic
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish 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

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 study if you:

  • Are HIV-positive.
  • Are at least 18 years old.
  • Have a viral load of at least 5,000 copies/ml and a CD4 count of at least 100 cells/mm3.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have received more than 4 weeks of treatment with nucleoside anti-HIV medications (NRTIs), or more than 1 week with protease inhibitors. (All anti-HIV treatments other than study medications must be stopped at least 14 days prior to study entry.)
  • Have severe diarrhea.
  • Are pregnant or breast-feeding.
  • Have a history of pancreatic disease or any other serious condition.
  • Have hepatitis within 30 days prior to study entry.
  • Cannot take medications by mouth.
  • Have received certain medications.

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
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

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 Major Dates

Study Start

March 1, 1999

Primary Completion (Actual)

March 1, 1999

Study Completion (Actual)

March 1, 1999

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)

April 25, 2011

Last Update Submitted That Met QC Criteria

April 13, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 039G
  • AI454-158

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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