Completed

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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What is being tested

Thymalfasin

+ Interleukin-2, Polyethylene Glycolated

+ Zidovudine

Drug

Who is being recruted

HIV Infections

Over 18 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Last updated: July 30, 2008

Sourced from a government-validated database.Claim as a partner

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. 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.

Official TitleSafety and Efficacy of Polyethylene Glycolated IL-2 (PEG IL-2) Plus Zidovudine and Thymosin Alpha 1 in HIV-Positive, Asymptomatic and Symptomatic Individuals

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Last updated: July 30, 2008

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

12 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sexBiological sex of participants that are eligible to enroll.

Over 18 YearsRange of ages for which participants are eligible to join.

Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

HIV Infections

Criteria

No eligibility criteria are available at this time.Please check with the study contact for more details.

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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Stanford Univ Med CtrStanford, United StatesSee the location

CompletedOne Study Center