A Phase I/II Double-Blind Controlled Trial to Determine the Safety and Immunogenicity of HIV-1 MN rgp160 Immuno AG Vaccine Therapy in HIV-Infected Individuals With Greater Than or Equal to 500/mm3 CD4+ T Cells and 200-400/mm3 CD4+ T Cells

Inclusion Criteria Concurrent Medication: Allowed: ddI [AS PER AMENDMENT 11/12/96: and d4T]. (Note: Patients in the stratum receiving only vaccine or control may take ddI [AS PER AMENDMENT 11/12/96: and d4T] ONLY IF their CD4 counts have shown a sustained decrease on two consecutive occasions 10-14 days apart.) PCP prophylaxis. Treatment for acute conditions, as indicated. AS PER AMENDMENT 11/12/96: Co-enrollment on other research trials. Patients must have: HIV positivity. Asymptomatic disease. CD4 count >= 50 cells/mm3 (CD4 count must be 50-499 cells/mm3 in patients receiving ddI plus vaccine or control, and must be >= 500 cells/mm3 in patients receiving vaccine or control only) [AS PER AMENDMENT 11/12/96: CD4 count >= 500 cells/mm3 for stratum 1 patients and 200-400 for stratum 2 patients]. HLA A2 positive documentation. An Epstein Barr virus B cell line established within 90 days prior to study entry. Consent of parent or guardian if less than 18 years of age. NOTE: Study is NOT approved for prisoner participation. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Medical contraindication to study participation or inability to comply with study requirements. Grade 2 or worse peripheral neuropathy (applicable only to patients receiving ddI plus vaccine or control). Concurrent Medication: Excluded: Immunomodulating agents, such as inosiplex, ditiocarb sodium, lithium, interferons, interleukin-2, and systemic steroids. Any antiretroviral therapy that may increase the risk of peripheral neuropathy (e.g., stavudine, zalcitabine [AS PER AMENDMENT 11/12/96: e.g., zalcitabine or lamivudine]). Agents such as IV pentamidine that may increase the risk of pancreatitis. Standard of care vaccines (in patients receiving vaccine) [AS PER AMENDMENT 11/12/96: Standard of care immunizations are permitted 60 days before Schedule 1 vaccine therapy and during Schedule 2 vaccine therapy (but not within 2 weeks of study immunization)]. AS PER AMENDMENT 11/12/96: Rifabutin, disulfiram (antabuse), or other medication with similar effects, including metronidazole. 6.AS PER AMENDMENT 11/12/96: The following are prohibited in patients receiving ritonavir: amiodarone, astemizole, bepridil, bupropion, cisapride, clozapine, encainide, flecainide, meperidine, piroxicam, propafenone, propoxyphene, quinidine, rifabutin, terfenadine, alprazolam, clorazepate, diazepam, estazolam, flurazepam, midazolam, triazolam, and zolpidem. Patients with the following prior conditions are excluded: History of grade 2 or worse liver abnormality. Known allergy to vaccine components. Chronic diarrhea persisting for 4 or more weeks within 30 days prior to study entry. History of pancreatitis (applicable only to patients receiving ddI plus vaccine or control). [AS PER AMENDMENT 11/12/96: History of chronic pancreatitis or history of acute pancreatitis within 2 years prior to entry (stratum 2 patients only).] Prior Medication: Excluded: Any prior anti-HIV vaccines. Excluded within 90 days prior to study entry: Immunomodulating agents, such as Inosiplex, ditiocarb sodium, lithium, interferons, interleukin-2, and systemic steroids. Any antiretroviral therapy that may increase the risk of peripheral neuropathy (e.g., stavudine, zalcitabine [AS PER AMENDMENT 11/12/96: e.g., zalcitabine or lamivudine]). Agents such as IV pentamidine that may increase the risk of pancreatitis. Any treatment for an AIDS-defining illness (applicable ONLY to patients in the stratum receiving ddI plus vaccine or control). Excluded within 6 months prior to study entry: Any other antiretrovirals or immunomodulators besides those mentioned above. Allergy desensitization or other vaccines [AS PER AMENDMENT 11/12/96: excluded within 60 days prior to entry].