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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.
Study NCT00002429.   Last updated on October 1, 2007.   Information provided by Bristol-Myers Squibb

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Descriptive Information Fields
Brief Title  Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
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
Brief Summary

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.

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Parallel Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  Drug: Lamivudine/Zidovudine
Drug: Nelfinavir mesylate
Drug: Stavudine
Drug: Didanosine
MEDLINE PMIDs
Links BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  500
Start Date  July 1999
Completion Date
Eligibility 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00002429
Organization ID 039F
Secondary IDs †† AI454-152
Study Sponsor  Bristol-Myers Squibb
Collaborators ††
Investigators 
Study Director:     Bristol-Myers Squibb     Bristol-Myers Squibb    
Information Provided By Bristol-Myers Squibb
Verification Date October 2007
First Received Date  November 2, 1999
Last Updated Date October 1, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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