Active Immunization of Asymptomatic, HIV-Infected Individuals With Recombinant GP160 HIV-1 Antigen: A Phase I/II Study of Immunogenicity and Toxicity

Exclusion Criteria

• •Patients with CD4 counts of 400 - 500 cells/mm3 must be informed of the recommended zidovudine (AZT) therapy and sign an informed consent statement declining AZT therapy.
• •Co-existing Condition:
• •Patients with the following conditions or symptoms are excluded:
• •Fever of \> 100 degrees F persisting for \> 15 days in a 30-day interval without definable cause.
• •Recurrent oral candidiasis.
• •Multidermatomal herpes zoster.
• •Biopsy-proven hairy leukoplakia.
• •Fatigue/malaise of \> 1 month duration that interferes with normal activities.
• •Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam.
• •Involuntary weight loss \> 10 lbs or 10 percent of normal weight in a 6 month interval.
• •Diarrhea (\> 3 stools/day) for more than 30 days without definable cause.
• •Concurrent Medication:
• •Excluded:
• •Antiretroviral agents of proven or potential efficacy or any potential immunoenhancing or immunosuppressive drugs.
• •Patients with the following are excluded:
• •Known hypersensitivity to insect cells or baculovirus.
• •Abnormal chest x-ray taken within 3 months of study entry.
• •Systemic symptoms thought to be due to HIV infection (other than lymphadenopathy). Evidence of clinically significant central nervous system dysfunction as assessed by neurological exam.
• •Unwilling or unable to give written informed consent.
• •Prior Medication:
• •Excluded within 90 days of study entry:
• •Zidovudine (AZT), didanosine (ddI), or any potential antiretroviral or immunomodulating agents.
• •Active substance abuse (either continuing daily alcohol abuse or intravenous drug use).