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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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
500
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

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

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