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

NCT ID: NCT00001036

Last Updated: 2008-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL

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.

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.

Conditions

HIV Infections

Keywords

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Thymalfasin

Intervention Type: DRUG

Interleukin-2, Polyethylene Glycolated

Intervention Type: DRUG

Zidovudine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Principal Investigators

TC Merigan

Role: STUDY_CHAIR

Locations

Stanford Univ Med Ctr

Stanford, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 8603940 (View on PubMed)

Other Identifiers

ACTG 236

Identifier Type: -

Identifier Source: org_study_id