Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen - Tabular View

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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

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

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

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

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.