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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000664
First received: November 2, 1999
Last updated: August 1, 2008
Last verified: December 1994
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: Interleukin-2, Polyethylene Glycolated
Drug: Zidovudine
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 26
Detailed Description:

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); Group C - asymptomatic with T4 count < 200 cells/mm3 (5 patients); Group D - diagnosed as having AIDS related complex (ARC) or AIDS (7 patients). All patients receive AZT. After a minimum 2-week period of AZT, patients receive an infusion of PEG IL-2 at 3 consecutive weekly intervals, followed by a 3-week period of AZT alone. This cycle (3 weeks of AZT and PEG IL-2 followed by 3 weeks of AZT alone) is repeated a total of three times (for a total of 18 weeks) followed by 8 weeks of AZT alone.

PER AMENDMENT: Ten patients may qualify for one of two groups: Group 1 - T4 count 200 - 400 cells/mm3 and meet all criteria established for Group B of the original protocol; Group 2 - T4 count < 200 cells/mm3 and meet all criteria established for Groups C and D of original protocol. Patients will receive an amended schedule of PEG IL2 IV every other week for eight doses, with dose escalation every other week for eight weeks permitted only in Group 2 patients who failed to show a 20 percent rise in T4 count at week 9 and who suffered no CNS or other adverse events at the lower dose.

PER ADDITIONAL AMENDMENT: Up to 10 additional patients may be treated at each dose of PEG IL2 on the biweekly schedule. Patients who respond to treatment on the biweekly schedule are eligible for an additional 9 weeks at their current dose.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000664

Locations
United States, California
Stanford Univ School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Investigators
Study Chair: TC Merigan
Study Chair: J Korvick
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00000664     History of Changes
Other Study ID Numbers: ACTG 141, CS-PG89-36, FDA 70A
Study First Received: November 2, 1999
Last Updated: August 1, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Polyethylene Glycols
Interleukin-2
Drug Evaluation
Zidovudine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Interleukin-2
Zidovudine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on August 28, 2014