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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002429
• Other study ID #: 039F
• Secondary ID: AI454-152
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: April 28, 2011
• Start date: July 1999
• Est. completion date: January 2001

Study information

• Verified date: April 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Lamivudine/Zidovudine

• Nelfinavir mesylate

• Stavudine

• Didanosine

Locations

Country	Name	City	State
Canada	Clinique Medicale du Quartier Latin	Montreal	Quebec
Canada	Clinique Medicale L'Actuele	Montreal	Quebec
Canada	Dr Roger P Leblanc	Montreal	Quebec
United States	Sorra Research Ctr / Med Forum	Birmingham	Alabama
United States	The CORE Ctr	Chicago	Illinois
United States	Ohio State Univ Hosp Clinic	Columbus	Ohio
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Henry Ford Hosp	Detroit	Michigan
United States	Med Alternatives	Fort Lauderdale	Florida
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Gathe, Joseph, M.D.	Houston	Texas
United States	Montrose Clinic	Houston	Texas
United States	Indiana Univ Med Ctr	Indianapolis	Indiana
United States	Dartmouth-Hitchcock Med Ctr	Lebanon	New Hampshire
United States	AIDS Healthcare Foundation	Los Angeles	California
United States	NJCRI	Newark	New Jersey
United States	County Line Med CtrInc	Pembrook	Florida
United States	Body Positive	Phoenix	Arizona
United States	Anderson Clinical Research	Pittsburgh	Pennsylvania
United States	San Francisco Gen Hosp	San Francisco	California
United States	Infectious Disease Assoc of Central Jersey	Somerville	New Jersey
United States	Dr Gerald Pierone Jr	Vero Beach	Florida
United States	Univ of Kansas School of Medicine	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Gathe J, Badero R, Grimwood A, Abrams L, Klesczewski K, Mclaren C. AI454152: Comparison of a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine Administered Once-Daily Versus a Regimen of Combivir Plus Nelfinavir. 8th Conference on Retroviruses and Opportunistic Infections, 2001 Feb 4-8. (abstract no 319)

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm