Status:

COMPLETED

The Safety and Effectiveness of Injections of Human Recombinant Interferon-gamma in Patients With AIDS Who Have Taken Zidovudine

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

Brief Summary

To find out which of four doses of (recombinant) human interferon gamma (IFN-G) is most effective in stimulating the white blood cells (monocytes) to fight infection and to see if treatment with IFN-G...

Detailed Description

AIDS is a disease that progressively destroys that aspect of the body's defense called the immune system. It is particularly harmful to a class of cells called helper T-lymphocytes. The specific oppor...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylactic antibiotics.
  • Tylenol (650 mg orally every 6 hours as needed for temperature > 38.5 degrees C).
  • Meperidine (25 - 50 mg intravenously, once, for severe rigors if systolic blood pressure is > 90 mmHg).

Patients must meet criteria for AIDS classification (CDC) category IV C-1.

  • Patients must have had one or more prior opportunistic infections identified in surveillance definition of AIDS. Patients whose AIDS-defining illness is Kaposi's sarcoma are also eligible if they have previously had one of the secondary infectious diseases identified in category C-1.

Prior Medication:

Required:

  • Patients must have been receiving zidovudine (AZT) on a stable dosage regimen for at least 8 weeks immediately preceding entry into study.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

  • Clinically significant cardiac (= or > class II, New York Heart Association) or peripheral vascular disease that requires treatment.
  • Presence of an active opportunistic infection that requires treatment.
  • Hemorrhagic diathesis or active bleeding disorder.
  • Clinically apparent vascular disease.

Concurrent Medication:

Excluded:

  • Medications required for treatment of active cardiac disease.
  • Ongoing therapy with anticoagulants or thrombolytic agents.

Patients with the following are excluded:

  • Clinically significant cardiac (= or > class II, New York Heart Association) or peripheral vascular disease that requires treatment.
  • Presence of an active opportunistic infection that requires treatment.
  • Hemorrhagic diathesis or active bleeding disorder.
  • Clinically apparent vascular disease.

Prior Medication:

Excluded within 4 weeks of study entry:

  • Antiviral chemotherapy other than zidovudine.
  • Excluded within 12 weeks of study entry:
  • Immunosuppressive or cytotoxic therapy.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

April 1 1993

Estimated Enrollment :

5 Patients enrolled

Trial Details

Trial ID

NCT00001112

End Date

April 1 1993

Last Update

November 4 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Cornell University A2201

New York, New York, United States, 10021