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

November 2, 1999
April 13, 2011
March 1999
March 1999   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00002224 on ClinicalTrials.gov Archive Site
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Comparison of Two Anti-HIV Regimens That Include One of Two Forms of Didanosine (ddI)
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
  • Drug: Nelfinavir mesylate
  • Drug: Stavudine
  • Drug: Didanosine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
March 1999
March 1999   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00002224
039G, AI454-158
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Bristol-Myers Squibb
Not Provided
Principal Investigator: . . .
Bristol-Myers Squibb
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP