Search / Trial NCT00000664

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Trial Information

Current as of December 26, 2024

Completed

Keywords

Polyethylene Glycols Interleukin 2 Drug Evaluation Zidovudine

ClinConnect Summary

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.

Four groups are studied for a period of at least 25 weeks. Patients are observed for a minimum of 6 hours after infusion of PEG IL2. The 4 groups of patients are: Group A - asymptomatic with T4 count \> 400 cells/mm3 (7 patients); Group B - asymptomatic with T4 count between 200 and 400 cells/mm3 (7 patients); Gro...

Gender

ALL

Eligibility 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.

Trial Officials

TC Merigan

Study Chair

J Korvick

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Stanford, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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