Search / Trial NCT00002429

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

Launched by BRISTOL-MYERS SQUIBB · Aug 30, 2001

Trial Information

Current as of December 27, 2024

Completed

Keywords

Didanosine Drug Therapy, Combination Stavudine Rna, Viral Nelfinavir Reverse Transcriptase Inhibitors Anti Hiv Agents

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • 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).
  • Exclusion Criteria
  • 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.

Trial Officials

Bristol-Myers Squibb

Study Director

Bristol-Myers Squibb

About Bristol Myers Squibb

Bristol-Myers Squibb (BMS) is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. With a robust portfolio of products across multiple therapeutic areas, including oncology, immunology, cardiovascular, and fibrotic diseases, BMS emphasizes cutting-edge research and a commitment to advancing medical science through clinical trials. The company is driven by a mission to provide transformative therapies, leveraging collaboration and scientific expertise to address unmet medical needs and improve patient outcomes worldwide.

Locations

Columbus, Ohio, United States

Detroit, Michigan, United States

San Francisco, California, United States

Dallas, Texas, United States

Houston, Texas, United States

Hampton, Virginia, United States

Wichita, Kansas, United States

Indianapolis, Indiana, United States

Los Angeles, California, United States

Birmingham, Alabama, United States

Montreal, Quebec, Canada

Montreal, Quebec, Canada

Houston, Texas, United States

Chicago, Illinois, United States

Pittsburgh, Pennsylvania, United States

Lebanon, New Hampshire, United States

Phoenix, Arizona, United States

Fort Lauderdale, Florida, United States

Newark, New Jersey, United States

Somerville, New Jersey, United States

Pembrook, Florida, United States

Vero Beach, Florida, United States

Montreal, Quebec, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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