Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (23)
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
Scroll for more (13 remaining)Sorra Research Ctr / Med Forum🇺🇸Birmingham, Alabama, United States