Phase I Trial of the Combination of Zidovudine and Recombinant Interleukin-2 in Patients With Persistent Generalized Lymphadenopathy

Inclusion Criteria

   - Detectable HIV nucleic acid in patient peripheral blood mononuclear leukocytes
   (PBML's) by the gene amplification technique. A positive antibody to HIV confirmed by
   any federally licensed ELISA test kit.

Concurrent Medication:

Allowed:

   - Medications without which there might be significant risk, such as seizures, loss of
   diabetic control or respiratory embarrassment.

   - Necessary topical agents including topical acyclovir.

   - Diuretics for significant fluid retention only.

Concurrent Treatment:

Allowed:

   - Blood transfusions for anemia if hematocrit falls below 25 percent.

Exclusion Criteria

   - Active drug or alcohol abuse.

Co-existing Condition:

Patients with the following will be excluded:

   - Grade 1 impairment on two or more items in the ACTG Micro Neuro AIDS assessment.

   - Concurrent neoplasms other than basal cell carcinoma of the skin or in situ carcinoma
   of the cervix.

   - Major organ allograft.

   - Significant cardiac disease or central nervous system lesions.

   - Patients with hemophilia should be evaluated and treated under the hemophilia
   protocol.

Concurrent Medication:

Excluded:

   - Inderal or vasoactive hypertensive medication.

   - Non-essential medications including pain medications.

Excluded are:

   - Patients with an opportunistic infection or malignancy fulfilling the definition of
   AIDS.

Patients with AIDS related complex, defined as:

   - 1. Weight loss in excess of 15 lbs. or 10 percent of body weight noted in a 2-year
   period prior to entry into the study. 2. Temperature greater than 38.5 degrees C with
   or without night sweats, persisting for more than 14 consecutive days or more than 15
   days in a 30-day interval during a 2-year period prior to entry into the study. 3.
   Diarrhea defined as = or > 3 liquid stools per day, persisting for more than 30 days
   during a 2-year period prior to entry into the study without a definable cause. 4.
   Herpes zoster during the past 2 years. 5. Oral candidiasis or biopsy-proven hairy
   leukoplakia during the last 2 years. 6. Active substance abuse.

Prior Medication:

Excluded:

   - Zidovudine (AZT).

   - Excluded within 30 days of study entry:

   - Antiretroviral agents.

   - Biologic response modifiers.

   - Corticosteroids.

   - Excluded within 60 days of study entry:

   - Ribavirin.