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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Thymalfasin
Interleukin-2, Polyethylene Glycolated
Zidovudine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring T-Lymphocytes, Polyethylene Glycols, Interleukin-2, Drug Therapy, Combination, Adjuvants, Immunologic, Acquired Immunodeficiency Syndrome, Zidovudine, thymosin alpha(1)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Univ Med Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
July 29, 2008
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00001036
Brief Title
The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 1996
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
T-Lymphocytes, Polyethylene Glycols, Interleukin-2, Drug Therapy, Combination, Adjuvants, Immunologic, Acquired Immunodeficiency Syndrome, Zidovudine, thymosin alpha(1)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Thymalfasin
Intervention Type
Drug
Intervention Name(s)
Interleukin-2, Polyethylene Glycolated
Intervention Type
Drug
Intervention Name(s)
Zidovudine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TC Merigan
Official's Role
Study Chair
Facility Information:
Facility Name
Stanford Univ Med Ctr
City
Stanford
State/Province
California
ZIP/Postal Code
943055107
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8603940
Citation
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.
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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

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