Status:
COMPLETED
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine in HIV Positive, Asymptomatic and Symptomatic Individuals
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 combinati...
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 antivi...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00000664
Last Update
August 4 2008
Active Locations (1)
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1
Stanford Univ School of Medicine
Stanford, California, United States, 94305