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NCT00001036 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT00001036: Completed Phase 1 study of HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00001036 is a Phase 1 study of HIV Infections that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 12 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001036, a Phase 1 study of HIV Infections, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

HIV Infections

Interventions

  • DRUG Zidovudine
  • DRUG Thymalfasin
  • DRUG Interleukin-2, Polyethylene Glycolated

Study Locations (1)

California

  • Stanford Univ Med Ctr - Stanford

Trial Details

FieldValue
Enrollment Target 12 participants
Phase Phase 1
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT00001036 record still lists

NCT00001036 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (97% lower).

The record links to 1 condition, with HIV Infections appearing as the primary indexed condition, and to 3 interventions - of which Zidovudine is the first listed.

NCT00001036 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT00001036 about?

NCT00001036 is a clinical study titled "The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection". 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...

What is the current status of trial NCT00001036?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants.

What conditions does trial NCT00001036 study?

This clinical trial studies the following conditions: HIV Infections.

What interventions are being tested in trial NCT00001036?

The interventions under investigation include: Zidovudine (DRUG), Thymalfasin (DRUG), Interleukin-2, Polyethylene Glycolated (DRUG).

Who is sponsoring clinical trial NCT00001036?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00001036 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00001036's enrollment target sits among peer trials

12 519th of 542 higher than 18 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00001036, the US trial registry maintained by the National Library of Medicine. NCT00001036 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.