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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001036
First received: November 2, 1999
Last updated: July 29, 2008
Last verified: October 1996
  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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 12
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001036

Locations
United States, California
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Sponsors and Collaborators
Investigators
Study Chair: TC Merigan
  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:
Acquired Immunodeficiency Syndrome
Communicable Diseases
HIV Infections
HIV Seropositivity
Infection
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Interleukin-2
Zidovudine
Analgesics
Analgesics, Non-Narcotic
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014