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Trial · Interventional

CompletedPhase 1Registry data

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

Overview

Status
Completed
Phase
Phase 1
Enrollment
12 participants
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · Nih
Design
Not stated
Countries
1 country

United States

Start
Not stated
Primary completion
Not stated
Completion
Not stated
First posted
31 Aug 2001 (estimated)
Last update posted
30 Jul 2008 (estimated)
Conditions
HIV Infections

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ThymalfasinDrug
  • Interleukin-2, Polyethylene GlycolatedDrug
  • ZidovudineDrug

Arms0

The registry lists no arms for this trial.

Primary outcomes0

Outcomes the sponsor listed as primary.

The registry lists no primary outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 1996

3 results

Polyethylene glycol-modified interleukin-2 and thymosin alpha 1 in human immunodeficiency virus type 1 infection.

Ramachandran et al. 1996The Journal of infectious diseasescited by 9

PMID 8603940DOI 10.1093/infdis/173.4.1005PUB-08603940

Rights unknown3 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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