Status:

COMPLETED

The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection

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 thymosin alpha 1 given twice weekly in a regimen of daily oral zidovudine (AZT) and biweekly polyethylene glycolated interleukin-2 (PEG IL-2). To determine the effect of thy...

Detailed Description

AIDS is characterized by diminished T helper cell number and function. Thymosin alpha 1 appears to both increase IL-2 receptors on lymphocytes in vitro and enhance lymphocyte maturation in vivo; thus,...

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Prophylactic pentamidine for Pneumocystis carinii.

Patients must have:

  • HIV seropositivity.
  • CD4 count > 50 and < 200 cells/mm3.
  • No active opportunistic infections.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Concurrent neoplasms other than basal cell carcinoma of the skin, in situ carcinoma of the cervix, or Kaposi's sarcoma.
  • Significant cardiac disease or CNS lesions or other neurologic abnormalities.
  • Score of > 0.5 on ACTG AIDS Dementia Complex staging.
  • Major organ allograft.
  • Intolerance to AZT at 500 mg/day.

Concurrent Medication:

Excluded:

  • Antihypertensive medication other than diuretics.
  • Chemotherapy, hormonal therapy, or other immunotherapy.
  • Other investigational drugs, agents, or devices.
  • Beta-blockers.
  • Non-topical steroids.

Concurrent Treatment:

Excluded:

  • Radiation therapy.

Prior Medication:

Excluded:

  • Known anti-HIV medication (other than AZT) or known immunomodulators (e.g., systemic steroids, interferons, interleukins) or other chemotherapy within 30 days prior to study entry.

Prior Treatment:

Excluded:

  • Transfusion within 4 weeks prior to study entry.
  • Radiation within 30 days prior to study entry.

Active substance abuse.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

12 Patients enrolled

Trial Details

Trial ID

NCT00001036

Last Update

July 30 2008

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Stanford Univ Med Ctr

Stanford, California, United States, 943055107