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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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