DRUG
The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection
Status
Completed
Phase
Phase 1
Enrollment
12
Locations
1
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
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.
Full 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.
Interventions
Treatment arms and agents.
DRUG
Interleukin-2, Polyethylene Glycolated
DRUG
Zidovudine
Timeline
From registration to results.
First posted
Aug 31, 2001
Study start
Not reported
Primary completion
Not reported
Study completion
Not reported
Results posted
Not reported
Registry updated
Jul 30, 2008
Outcomes
What the study measures.
Primary outcomes
Not reported in the indexed record.
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Stanford Univ Med Ctr
Stanford, California, United States
Publications
Results and literature.
Related trials
More studies on Thymosin Alpha-1.
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Recruiting
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2026-07
Thymosin-α1 for Recurrent Implantation Failure
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Phase 2 / Phase 3
Recruiting
136
2026-06
Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer
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Not applicable
Completed
47
2026-06
Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma
Sun Yat-sen University · Melanoma · Immune-related Adverse Event
Phase 2
Recruiting
55
2026-06
TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma
Fudan University · Esophageal Squamous Cell Carcinoma
Not applicable
Active, not recruiting
50
2026-04
Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients
William B. Ershler, MD · COVID-19
Phase 2
Completed
189
2026-04
Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma
The First Affiliated Hospital with Nanjing Medical University · Gastric Cancer
Phase 2
Recruiting
48
2026-03
Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma
Zekuan Xu · Gastric Cancer · Esophagogastric Junction Adenocarcinoma
Phase 2
Recruiting
30
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