Expired Study
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Stanford, California 94305


Purpose:

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.


Study summary:

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. Patients are stabilized on oral AZT daily for 8 weeks and then begin receiving bolus infusions of PEG IL-2 every other week for at least four doses. Thymosin alpha 1 (given SC) is then added to this regimen twice weekly for 4 weeks. If no significant toxicity occurs, thymosin alpha 1 is increased to and administered along with scheduled doses of PEG IL-2 for an additional 8 weeks.


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.


NCT ID:

NCT00001036


Primary Contact:

Study Chair
TC Merigan


Backup Contact:

N/A


Location Contact:

Stanford, California 94305
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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