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].

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety