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Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
Not Recruiting
Trial ID: NCT00000664
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.
Official Title
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
Stanford Investigator(s)
Eligibility
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.
Intervention(s):
drug: Interleukin-2, Polyethylene Glycolated
drug: Zidovudine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305