A Phase I Study To Determine the Safety of the Optimal Monocyte Activating Administration Schedule of Subcutaneous Human Recombinant Interferon-gamma in ZDV-Treated Patients With AIDS


Phase 1
18 Years
65 Years
Not Enrolling
Both
HIV Infections

Thank you

Trial Information

A Phase I Study To Determine the Safety of the Optimal Monocyte Activating Administration Schedule of Subcutaneous Human Recombinant Interferon-gamma in ZDV-Treated Patients With AIDS


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 opportunistic infections and malignancies associated with AIDS have been
treated with therapies that are often poorly tolerated by the patients and are associated
with dose-limiting toxicities. The principal focus of AIDS therapy research at present is to
control the underlying retroviral infection and to restore immune function with recombinant
lymphokines, adoptive immunotherapy, and/or lymphocyte transplants. These treatments include
zidovudine (AZT), which has been shown to control the HIV infection, and IFN-G, a lymphokine
which activates tumor-destroying and germ-killing functions. Studies are needed to find the
dose by which IFN-G works best.

Patients, who may participate in all three parts of the study, are maintained on a stable
dose of AZT. In part A (optimal dose), five AIDS patients who have had an AIDS related
opportunistic infection receive 4 once-weekly increasing doses of IFN-G. Monocyte
antimicrobial activity is examined in test tube studies before and after each injection of
IFN-G. In part B, five patients receive the optimal dose of IFN-G established in part A.
Patients enrolled from part A have completed at least 2 weeks of part A before enrolling in
part B. Antimicrobial activity is examined 1, 2, and 3 days after a single injection of the
optimal dose of IFN-G (determined in part A). In part C (safety and tolerance of combined
treatment of IFN-G and AZT), patients are treated with IFN-G for 4 weeks using the optimal
dose and administration schedule derived from parts A and B.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

HW Murray

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 072

NCT ID:

NCT00001112

Start Date:

Completion Date:

April 1993

Related Keywords:

  • HIV Infections
  • Monocytes
  • Interferon-gamma, Recombinant
  • Injections, Subcutaneous
  • Immune System
  • Drug Evaluation
  • Drug Therapy, Combination
  • Acquired Immunodeficiency Syndrome
  • Zidovudine
  • Blood Bactericidal Activity
  • HIV Infections
  • Acquired Immunodeficiency Syndrome

Name

Location
Cornell University A2201 New York, New York  10021