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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Page 1 of 1 (1 locations)

1

Stanford Univ School of Medicine

Stanford, California, United States, 94305