ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)

This study has been completed.
Study NCT00002224.   Last updated on August 15, 2007.   Information provided by Bristol-Myers Squibb

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)
Official Title  Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily
Brief Summary

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).

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 Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  HIV Infections
Intervention  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  120
Start Date  March 1999
Completion Date March 1999
Eligibility 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.
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00002224
Organization ID 039G
Secondary IDs †† AI454-158
Study Sponsor  Bristol-Myers Squibb
Collaborators ††
Investigators 
Principal Investigator:     . .     .    
Information Provided By Bristol-Myers Squibb
Verification Date August 2007
First Received Date  November 2, 1999
Last Updated Date August 15, 2007

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




Links to all studies - primarily for crawlers