The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Thymalfasin Drug: Interleukin-2, Polyethylene Glycolated Drug: Zidovudine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine and Thymosin Alpha 1 in HIV-Positive, Asymptomatic and Symptomatic Individuals |
| Estimated Enrollment: | 12 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00001036 History of Changes |
| Other Study ID Numbers: | ACTG 236 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 29, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
T-Lymphocytes Polyethylene Glycols Interleukin-2 Drug Therapy, Combination |
Adjuvants, Immunologic Acquired Immunodeficiency Syndrome Zidovudine thymosin alpha(1) |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome HIV Seropositivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Adjuvants, Immunologic Thymalfasin Interleukin-2 |
Zidovudine Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013