Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety of polyethylene glycolated IL-2 (PEG IL2) administered weekly or biweekly (per amendment) in a setting of oral zidovudine (AZT). To determine the effect of PEG IL2 in combination with AZT on parameters assessing the immune system as well as HIV virus and antibody titers. To evaluate a chronic dosing study phase offered to patients who complete the initial 25-week regimen.

Recent research has focused on enhancing cell-mediated immunity and reducing or eliminating viral replication (reproduction and growth). A main thrust of current treatment is the combination of antiviral drugs that may be more effective when combined than when each is used alone.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Interleukin-2; Zidovudine

Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Prophylactic pentamidine for Pneumocystis carinii pneumonia (PCP).

• Topical steroids.

Patients must:

• Be HIV positive. Fit one of the zidovudine use groups listed in Disease Status. Be able to give informed consent.

Allowed:

• Basal cell carcinoma of the skin, in situ carcinoma of the cervix, Kaposi's sarcoma.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• Major organ allograft.

• Significant cardiac disease or central nervous system lesions.

• Known previous intolerance to zidovudine (AZT) at 500 mg/day.

• Active opportunistic infections. Score of > 0.5 on the ACTG AIDS dementia complex staging test. Any focal abnormality on neurologic exam.

Concurrent Medication:

Excluded:

• Chemotherapy, hormonal therapy, or other immunotherapy.

• Other investigational drugs, agents, or devices.

• Beta-blockers.

• Steroids other than topical.

• Antihypertensive medication other than diuretics.

Concurrent Treatment:

Excluded:

• Radiation therapy.

Patients with the following are excluded:

• History of seizures. Concurrent neoplasms not specifically allowed.

• Concomitant conditions listed in Exclusion Co-existing Conditions.

Prior Medication:

Excluded within 30 days prior to study entry:

• Anti-HIV medication other than zidovudine (AZT).

• Immunomodulators.

• Systemic steroids.

• Interferons.

• Interleukins.

• Other chemotherapy.

Prior Treatment:

Excluded within 30 days prior to study entry:

• Radiation therapy.

Excluded within 4 weeks prior to study entry:

• Groups B, C, D

• Transfusions.

Active substance abuse.