The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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 thymosin alpha 1 and PEG IL-2 in combination with AZT on immunologic and pharmacokinetic markers. 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, the drug may further enhance the CD4 T cell levels in patients receiving AZT and PEG IL-2.
Key facts
- Study ID
- NCT00001036
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 12
- Last updated by the study team
- 2008-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Allowed:
- Prophylactic pentamidine for Pneumocystis carinii.
- Patients must have:
- HIV seropositivity.
- CD4 count > 50 and < 200 cells/mm3.
- No active opportunistic infections.
You may not qualify if…
- 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.
Where it is running
- Stanford Univ Med Ctr — Stanford, California, United States
Full record on ClinicalTrials.gov
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