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
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Zalcitabine, Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, Interferon-alpha
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.
Sites / Locations
- ViRx Inc
- Marin County Specialty Clinic
- Georgetown Univ Med Ctr
- Stratogen of South Florida
- Univ of South Florida
- Infectious Diseases Research Clinic / Indiana Univ Hosp
- Univ of Kansas School of Medicine
- North Shore Univ Hosp / Div of Infectious Diseases
- Univ of Cincinnati
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
- Vanderbilt School of Medicine
- Baylor College of Medicine
- Univ of Utah School of Medicine