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

Phase 3

Completed

• Conditions: HIV Infections

• Registration Number: NCT00002429
• Lead Sponsor: Bristol-Myers Squibb

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 Timeline

• Study Start: 1999-07
• Study First Submitted: 1999-11-02
• Primary Completion: 2001-01
• Study Completion: 2001-01
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2011-04
• Disposition First Submitted: 2011-04-13
• Disposition First Submitted QC: 2011-04-13
• Disposition First Posted: 2011-04-25
• Last Update Submitted: 2011-04-28
• Last Update Posted: 2011-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (23)

NJCRI; 🇺🇸 Newark, New Jersey, United States

Univ of Texas Southwestern Med Ctr of Dallas; 🇺🇸 Dallas, Texas, United States

Clinique Medicale L'Actuele; 🇨🇦 Montreal, Quebec, Canada

Dr Gerald Pierone Jr; 🇺🇸 Vero Beach, Florida, United States

Infectious Disease Assoc of Central Jersey; 🇺🇸 Somerville, New Jersey, United States

County Line Med CtrInc; 🇺🇸 Pembrook, Florida, United States

Med Alternatives; 🇺🇸 Fort Lauderdale, Florida, United States

Clinique Medicale du Quartier Latin; 🇨🇦 Montreal, Quebec, Canada

Henry Ford Hosp; 🇺🇸 Detroit, Michigan, United States

The CORE Ctr; 🇺🇸 Chicago, Illinois, United States

Body Positive; 🇺🇸 Phoenix, Arizona, United States

San Francisco Gen Hosp; 🇺🇸 San Francisco, California, United States

Sorra Research Ctr / Med Forum; 🇺🇸 Birmingham, Alabama, United States

Anderson Clinical Research; 🇺🇸 Pittsburgh, Pennsylvania, United States

Univ of Kansas School of Medicine; 🇺🇸 Wichita, Kansas, United States

Indiana Univ Med Ctr; 🇺🇸 Indianapolis, Indiana, United States

Ohio State Univ Hosp Clinic; 🇺🇸 Columbus, Ohio, United States

Gathe, Joseph, M.D.; 🇺🇸 Houston, Texas, United States

Dartmouth-Hitchcock Med Ctr; 🇺🇸 Lebanon, New Hampshire, United States

Hampton Roads Med Specialists; 🇺🇸 Hampton, Virginia, United States

Dr Roger P Leblanc; 🇨🇦 Montreal, Quebec, Canada

Montrose Clinic; 🇺🇸 Houston, Texas, United States

AIDS Healthcare Foundation; 🇺🇸 Los Angeles, California, United States