ClinConnect ClinConnect Logo
Search / Trial NCT00002086

A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of June 22, 2025

Completed

Keywords

Zalcitabine Drug Therapy, Combination Aids Related Complex Zidovudine Interferon Alpha

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have:
  • HIV infection documented by licensed ELISA confirmed by Western blot; OR positive HIV culture; OR positive HIV antigen; OR plasma viremia.
  • CD4 counts \>= 300 and \<= 500 cells/mm3 on two occasions within 30 days prior to study entry.
  • Patients \< 18 years of age must have written consent of parent or guardian. The effects of the combination therapy on infants or the developing fetus are unknown. Patients are encouraged to utilize adequate contraception while enrolled in the study.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Current AIDS-defining indicator disease, including opportunistic infections, AIDS dementia, AIDS-wasting syndrome, and AIDS-associated malignancy.
  • Grade 2 or worse peripheral neuropathy.
  • Intolerance to Retrovir at 600 mg/day, HIVID at 2.25 mg/day, or any interferon-alfa product at 3.0 MU/day.
  • Significant cardiac dysfunction (NYHA grade 3 or 4).
  • Concurrent Medication:
  • Excluded:
  • Chemotherapeutic agents during the 76 weeks following study entry.
  • Cardiac glycosides, antiarrhythmics, or vasodilators.
  • Patients with the following prior conditions are excluded:
  • History of AIDS-defining indicator disease, including opportunistic infections, AIDS dementia, AIDS-wasting syndrome, or AIDS-associated malignancy.
  • History of grade 2 or worse peripheral neuropathy.
  • History of intolerance to Retrovir at 600 mg/day, HIVID at 2.25 mg/day, or any interferon-alfa product at 3.0 MU/day.
  • Prior Medication:
  • Excluded:
  • More than 3 months of any prior antiretroviral therapy.
  • Cytotoxic chemotherapy within 4 weeks prior to study entry.
  • Immunomodulating agents such as systemic corticosteroids, IL-2, IFN-alfa, or IFN-beta within 4 weeks prior to study entry.
  • Cardiac glycosides, antiarrhythmics, or vasodilators.
  • Prior Treatment:
  • Excluded:
  • Radiation therapy within 4 weeks prior to study entry. Current alcohol or illicit drug use that would interfere with patient compliance.

About Glaxo Wellcome

Glaxo Wellcome, a leading global biopharmaceutical company, is dedicated to advancing healthcare through innovative research and development of new therapies. With a strong focus on addressing unmet medical needs, Glaxo Wellcome combines scientific excellence with a commitment to improving patient outcomes across various therapeutic areas, including respiratory, infectious diseases, and oncology. The company is recognized for its robust clinical trial portfolio, leveraging cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. Glaxo Wellcome upholds the highest ethical standards in clinical research, ensuring patient safety and integrity throughout the trial process.

Locations

Houston, Texas, United States

Washington, District Of Columbia, United States

Cincinnati, Ohio, United States

Wichita, Kansas, United States

Tampa, Florida, United States

Salt Lake City, Utah, United States

Portland, Oregon, United States

San Rafael, California, United States

San Francisco, California, United States

Indianapolis, Indiana, United States

Nashville, Tennessee, United States

Miami Beach, Florida, United States

Manhasset, New York, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials