Status:

COMPLETED

A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Immuno-US

Conditions:

HIV Infections

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

Brief Summary

To determine the safety and immunogenicity of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in asymptomatic HIV-infected adult volunteers. To compare safety and immunogenicity of tw...

Detailed Description

Potentiation of a patient's immune response to HIV might possibly prolong the period of clinical latency and protect the patient indefinitely. Preliminary results from a study of Immuno-AG recombinant...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication: Recommended:

  • Prophylaxis with isoniazid in patients not previously treated.

Patients must have:

  • HIV seropositivity by Western blot.
  • Normal history and physical exam (generalized lymphadenopathy is acceptable).
  • Mean CD4 cell count = or > 600 cells/mm3 for all visits (minimum 2 counts) within 60 days prior to study entry, with no single count < 450 cells/mm3.
  • Negative PPD test or normal chest x-ray with positive PPD (induration = or > 5 mm).

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Hepatitis B surface antigen positive.
  • Evidence of an AIDS- or ARC-defining opportunistic infection.
  • Evidence of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.
  • Active syphilis.

Patients with the following prior conditions are excluded:

  • Evidence of psychiatric disorder within the past year that would impair adherence to the protocol.
  • History of an AIDS- or ARC-defining opportunistic infection.
  • History of disseminated tuberculosis, severe or persistent candidiasis, oral hairy leukoplakia, prolonged or very severe diarrhea, herpes zoster, or herpes simplex persisting more than one month.

Prior Medication:

Excluded:

  • Immunomodulating agents (e.g., isoprinosine, imuthiol, lithium) within 90 days of screening.
  • Immunosuppressive medications within the previous 3 months.
  • Zidovudine (AZT) or any antiviral agent (including interferon) within the previous 6 months.
  • Vaccination against other pathogens within 4 weeks of initial screening laboratory work.

Use of illicit drugs or significant amounts of alcohol that could significantly interfere with study compliance.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

October 1 1998

Estimated Enrollment :

55 Patients enrolled

Trial Details

Trial ID

NCT00000633

End Date

October 1 1998

Last Update

November 2 2021

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States, 21287

2

Washington U CRS

St Louis, Missouri, United States, 63104