Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Bristol-Myers Squibb

Immuno-US

Conditions:

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE1

Brief Summary

To evaluate the safety and immunogenicity of HIV-1 MN rgp160 (Immuno-AG) in HIV-infected patients. To evaluate the immunogenicity of HIV-1 MN rgp160 immunogen by lymphocyte proliferation, specific ant...

Detailed Description

HIV-specific cellular immune responses appear to play an important role in HIV disease progression since both T helper and cytotoxic function against HIV decrease with disease progression. Patients w...

Eligibility Criteria

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].

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

May 1 1999

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT00000822

End Date

May 1 1999

Last Update

October 29 2021

Active Locations (1)

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Stanford CRS

Stanford, California, United States, 943055107