Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1 (Retrovir/HIVID/Wellferon) can produce complete responses (i.e., CD4 counts return to >= 800 cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To determine the antiviral effect of the combination therapies as evidenced by measures of quantitative viral load performed at select study centers only. Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in maintaining or increasing CD4 counts and preventing disease progression as evidenced by the development of an AIDS-defining indicator disease. To determine the effect of these regimens on secondary measures of clinical status (e.g., performance score, weight change, and secondary infections) and on measures of virologic activity such as serum p24 antigen. To assess the safety and tolerance of these regimens.

Condition	Treatment or Intervention	Phase
HIV Infections	Drug: Zidovudine  Drug: Zalcitabine  Drug: Interferon alfa-n1	Phase II

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

California
      ViRx Inc, San Francisco,  California,  94103,  United States
      Marin County Specialty Clinic, San Rafael,  California,  94903,  United States
District of Columbia
      Georgetown Univ Med Ctr, Washington,  District of Columbia,  20007,  United States
Florida
      Univ of South Florida, Tampa,  Florida,  33612,  United States
      Stratogen of South Florida, Miami Beach,  Florida,  33140,  United States
Indiana
      Infectious Diseases Research Clinic / Indiana Univ Hosp, Indianapolis,  Indiana,  46202,  United States
Kansas
      Univ of Kansas School of Medicine, Wichita,  Kansas,  67214,  United States
New York
      North Shore Univ Hosp / Div of Infectious Diseases, Manhasset,  New York,  11030,  United States
Ohio
      Univ of Cincinnati, Cincinnati,  Ohio,  452670560,  United States
Oregon
      Portland Veterans Adm Med Ctr / Rsch & Education Grp, Portland,  Oregon,  97210,  United States
Tennessee
      Vanderbilt School of Medicine, Nashville,  Tennessee,  37232,  United States
Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States
Utah
      Univ of Utah School of Medicine, Salt Lake City,  Utah,  84132,  United States

Study ID Numbers:  052C; 03
Record last reviewed:  October 1993
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002086
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08