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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1
Stanford Univ Med Ctr
Stanford, California, United States, 943055107