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

November 2, 1999
July 29, 2008
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Complete list of historical versions of study NCT00001036 on ClinicalTrials.gov Archive Site
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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
Safety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine and Thymosin Alpha 1 in HIV-Positive, Asymptomatic and Symptomatic Individuals

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
HIV Infections
  • Drug: Thymalfasin
  • Drug: Interleukin-2, Polyethylene Glycolated
  • Drug: Zidovudine
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Ramachandran R, Katzenstein DA, Winters MA, Kundu SK, Merigan TC. Polyethylene glycol-modified interleukin-2 and thymosin alpha 1 in human immunodeficiency virus type 1 infection. J Infect Dis. 1996 Apr;173(4):1005-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001036
ACTG 236
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National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: TC Merigan
National Institute of Allergy and Infectious Diseases (NIAID)
October 1996

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP