HIV Infections
Conditions
Keywords
T-Lymphocytes, Polyethylene Glycols, Interleukin-2, Drug Therapy, Combination, Adjuvants, Immunologic, Acquired Immunodeficiency Syndrome, Zidovudine, thymosin alpha(1)
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 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.
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, 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.
Interventions
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Countries
United States
Outcome results
None listed