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

NCT00001036 | Completed Phase 1

• 1 other identifier: ACTG 236
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 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.

Conditions

HIV Infections

Keywords

T-Lymphocytes; Polyethylene Glycols; Interleukin-2; Drug Therapy, Combination; Adjuvants, Immunologic; Acquired Immunodeficiency Syndrome; Zidovudine; thymosin alpha(1)

Interventions

Thymalfasin DRUG

Interleukin-2, Polyethylene Glycolated DRUG

Zidovudine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed:
• Prophylactic pentamidine for Pneumocystis carinii.
• Patients must have:
• HIV seropositivity.
• CD4 count \> 50 and \< 200 cells/mm3.
• No active opportunistic infections.

You may not qualify if:

• 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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Stanford Univ Med Ctr

Stanford, California, 943055107, United States

Location

Related Publications (1)

• 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. doi: 10.1093/infdis/173.4.1005.

  PMID: 8603940 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Interventions

Thymalfasin; Interleukin-2; Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Lymphokines; Biological Factors; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• TC Merigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: July 30, 2008

Record last verified: 1996-10

Locations

US (1)