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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine and Thymosin Alpha 1 in HIV-Positive, Asymptomatic and Symptomatic Individuals

Conditions
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HIV Infections

Intervention / Treatment
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* Drug: Thymalfasin
* Drug: Interleukin-2, Polyethylene Glycolated
* Drug: Zidovudine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thymalfasin|nan|
|Drug: Interleukin-2, Polyethylene Glycolated|nan|
|Drug: Zidovudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T-Lymphocytes, Polyethylene Glycols, Interleukin-2, Drug Therapy, Combination, Adjuvants, Immunologic, Acquired Immunodeficiency Syndrome, Zidovudine, thymosin alpha(1)