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

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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

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.