Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
3 other identifiers
interventional
26
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedAugust 4, 2008
December 1, 1994
November 2, 1999
August 1, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Univ School of Medicine
Stanford, California, 94305, United States
Related Publications (1)
Wood R, Montoya JG, Kundu SK, Schwartz DH, Merigan TC. Safety and efficacy of polyethylene glycol-modified interleukin-2 and zidovudine in human immunodeficiency virus type 1 infection: a phase I/II study. J Infect Dis. 1993 Mar;167(3):519-25. doi: 10.1093/infdis/167.3.519.
PMID: 8095058BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
TC Merigan
- STUDY CHAIR
J Korvick
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
August 4, 2008
Record last verified: 1994-12