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Clinical Trials

MainTitle

Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen

This study has been completed
Sponsor
Bristol-Myers Squibb


Information provided by (Responsible Party)
Bristol-Myers Squibb
ClinicalTrials.gov Identifier
NCT00002429

First received: November 2, 1999
Last updated: April 28, 2011
Last Verified: April 2011
History of Changes
Purpose

Purpose

This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.

Condition Intervention Phase
HIV Infections

Drug : Lamivudine/Zidovudine
Drug : Nelfinavir mesylate
Drug : Stavudine
Drug : Didanosine
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen

Further study details as provided by Bristol-Myers Squibb:

Enrollment: 500
Study Start Date: July 1999
Study Completion Date: January 2001
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)

Detailed Description:

Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria
Patients may be eligible for this study if they:

  • Are HIV-positive.
  • Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3.
  • Are at least 18 years old.
  • Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).

  • Exclusion Criteria
    Patients will not be eligible for this study if they:
  • Have had severe diarrhea within 30 days of study entry.
  • Have a history of pancreatic disease or any other serious condition.
  • Have hepatitis within 30 days of study entry.
  • Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.
  • Are unable to take medications by mouth.
  • Have received certain medications.
  • Are pregnant or breast-feeding.

contacts and locations

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: NCT00002429

Locations

United States, Alabama
Sorra Research Ctr / Med Forum
Birmingham, Alabama, United States, 35203
United States, Arizona
Body Positive
Phoenix, Arizona, United States, 85016
United States, California
AIDS Healthcare Foundation
Los Angeles, California, United States, 900276069
San Francisco Gen Hosp
San Francisco, California, United States, 94115
United States, Florida
Med Alternatives
Fort Lauderdale, Florida, United States, 33308
County Line Med CtrInc
Pembrook, Florida, United States, 33023
Dr Gerald Pierone Jr
Vero Beach, Florida, United States, 32960
United States, Illinois
The CORE Ctr
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Med Ctr
Indianapolis, Indiana, United States, 462025250
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 672143124
United States, Michigan
Henry Ford Hosp
Detroit, Michigan, United States, 48202
United States, New Hampshire
Dartmouth-Hitchcock Med Ctr
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
NJCRI
Newark, New Jersey, United States, 07103
Infectious Disease Assoc of Central Jersey
Somerville, New Jersey, United States, 08876
United States, Ohio
Ohio State Univ Hosp Clinic
Columbus, Ohio, United States, 432101228
United States, Pennsylvania
Anderson Clinical Research
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States, 75235
Gathe, Joseph, M.D.
Houston, Texas, United States, 77004
Montrose Clinic
Houston, Texas, United States, 77006
United States, Virginia
Hampton Roads Med Specialists
Hampton, Virginia, United States, 23666
Canada
Clinique Medicale du Quartier Latin
Montreal, Quebec, Canada
Clinique Medicale L'Actuele
Montreal, Quebec, Canada
Dr Roger P Leblanc
Montreal, Quebec, Canada

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

More Information

Additional Information:

BMS Clinical Trials Disclosure

Additional Information:

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Responsible Party: Bristol-Myers Squibb  
ClinicalTrials.gov Identifier: NCT00002429   History of Changes  
Other Study ID Numbers: 039F  
  AI454-152  
Study First Received: November 2, 1999  
Last Updated: April 28, 2011  

Keywords provided by Bristol-Myers Squibb:

Didanosine
Drug Therapy, Combination
Stavudine
RNA, Viral
Nelfinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Lamivudine
Zidovudine
Stavudine
Didanosine
Lamivudine, zidovudine drug combination
Nelfinavir

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.