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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002429

Run by

Bristol-Myers Squibb

People needed

500

Starts

1999-07-01

Expected to finish

2001-01-01

Last updated by the study team

2011-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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