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NCT00001032 · ClinicalTrials.gov registry record · Phase 2

A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
180
Enrollment target

NCT00001032: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00001032 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001032, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
180 participants
Enrollment target

Study Summary

PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children. SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria. In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.

Interventions

  • DRUG Zidovudine
  • DRUG Zalcitabine

Trial Details

FieldValue
Enrollment Target 180 participants
Est. Completion 1995-04
Phase Phase 2

What the finished NCT00001032 record still lists

NCT00001032 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).

The record links to 0 conditions, and to 2 interventions - of which Zidovudine is the first listed.

NCT00001032 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001032 about?

NCT00001032 is a clinical study titled "A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT". PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children. SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory marker...

What is the current status of trial NCT00001032?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. Estimated completion is 1995-04.

What interventions are being tested in trial NCT00001032?

The interventions under investigation include: Zidovudine (DRUG), Zalcitabine (DRUG).

Who is sponsoring clinical trial NCT00001032?

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

How this trial's enrollment target compares

Where NCT00001032's enrollment target sits among peer trials

180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT00001032, the US trial registry maintained by the National Library of Medicine. NCT00001032 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.