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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00002224
First received: November 2, 1999
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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).


Condition Intervention Phase
HIV Infections
Drug: Nelfinavir mesylate
Drug: Stavudine
Drug: Didanosine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Estimated Enrollment: 120
Study Start Date: March 1999
Study Completion Date: March 1999
Primary Completion Date: March 1999 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002224

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00002224     History of Changes
Other Study ID Numbers: 039G, AI454-158
Study First Received: November 2, 1999
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
Didanosine
Drug Therapy, Combination
Drug Administration Schedule
Stavudine
HIV Protease Inhibitors
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Stavudine
Reverse Transcriptase Inhibitors
Nelfinavir
HIV Protease Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014