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

Completed · Phase 3

Conditions studied: HIV Infections

In brief

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).

Key facts

Study ID

NCT00002224

Run by

Bristol-Myers Squibb

People needed

120

Starts

1999-03-01

Expected to finish

1999-03-01

Last updated by the study team

2011-04-25

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sorra Research Ctr / Med Forum — Birmingham, Alabama, United States
• AIDS Healthcare Foundation — Los Angeles, California, United States
• Robert Scott MD — Oakland, California, United States
• Beacon Clinic / Boulder Community Hosp — Boulder, Colorado, United States
• Community Health Care — Fort Lauderdale, Florida, United States
• Immunity Care and Research Inc — Fort Lauderdale, Florida, United States
• HIV Clinical Research Ctr — Fort Lauderdale, Florida, United States
• South Shore Hosp — Miami, Florida, United States
• Saint Josephs Comprehensive Research Institute — Tampa, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Chicago Ctr for Clinical Research — Chicago, Illinois, United States
• Univ of Kansas School of Medicine — Wichita, Kansas, United States
• Univ of Nebraska Med Ctr — Omaha, Nebraska, United States
• Clinical Studies of Las Vegas — Las Vegas, Nevada, United States
• Anderson Clinical Research Inc — Rego Park, New York, United States
• Anderson Clinical Research Inc — Reading, Pennsylvania, United States
• Coastal Carolina Research Ctr — Mt. Pleasant, South Carolina, United States
• Oak Lawn Physicians Group — Dallas, Texas, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Nicholaos Bellos — Dallas, Texas, United States
• Houston Clinical Research Network / Div of Montrose Clinic — Houston, Texas, United States
• Swedish Med Ctr — Seattle, Washington, United States
• Clinique Medicale du Quartier Latin — Montreal, Quebec, Canada
• Clinique Medicale L'Actuele — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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