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

HIV Infections Clinical Trial

Official title:
Comparison of HIV RNA Suppression Produced by Triple Regimens Containing Either Didanosine Enteric Coated or Didanosine Formulations Each Administered Once Daily

Clinical Trial 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).

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00002224
Study type Interventional
Source Bristol-Myers Squibb
Contact
Status Completed
Phase Phase 3
Start date March 1999
Completion date March 1999
View Details
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