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NCT00000678 · ClinicalTrials.gov registry record · Phase 2

Dideoxycytidine ( Ro 24-2027 ) A Randomized, Open-Label, Comparative Study of Dideoxycytidine ( ddC ) Versus Zidovudine ( AZT ) in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy.

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

Completed
Registry status
Phase 2
Development phase
320
Enrollment target

NCT00000678: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000678 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 320 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (141% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000678, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
320 participants
Enrollment target

Study Summary

To compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine ( AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients who have already received at least 1 year of AZT therapy and to define the safety profile. ddC has been shown to have an antiviral effect, and AZT is known to significantly decrease mortality and to reduce the frequency of opportunistic infections in patients with AIDS or advanced ARC. After 1 year of AZT therapy, the effectiveness tends to diminish and patients progress with more opportunistic infections and higher mortality rates. This may be due to the emergence of AZT resistant virus isolated from some patients who have been on long-term AZT therapy. These isolates were still sensitive to ddC. A study of long-term effectiveness of ddC in patients with AIDS or advanced ARC who have been on long-term AZT therapy is warranted because (1) ddC has antiviral activity, (2) there is no blood toxicity associated with taking ddC, and (3) the effectiveness of ddC in test tube studies does not seem to be diminished by decreased effectiveness of AZT.

Interventions

  • DRUG Zidovudine
  • DRUG Zalcitabine

Trial Details

FieldValue
Enrollment Target 320 participants
Phase Phase 2

What the finished NCT00000678 record still lists

NCT00000678 is an interventional study that assigns participants to a tested intervention. The registered 320 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 (141% higher).

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

NCT00000678 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000678 about?

NCT00000678 is a clinical study titled "Dideoxycytidine ( Ro 24-2027 ) A Randomized, Open-Label, Comparative Study of Dideoxycytidine ( ddC ) Versus Zidovudine ( AZT ) in Patients With AIDS or Advanced ARC Who Have Received Long-Term AZT Therapy.". To compare the effectiveness of zalcitabine ( dideoxycytidine; ddC ) therapy to zidovudine ( AZT ) in the treatment of AIDS or advanced AIDS related complex ( ARC ) in patients who have already received at least 1 year of AZT therapy and to define the safety profile. ddC has been shown to have an a...

What is the current status of trial NCT00000678?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 320 participants.

What interventions are being tested in trial NCT00000678?

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

Who is sponsoring clinical trial NCT00000678?

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 NCT00000678's enrollment target sits among peer trials

320 152nd of 2000 higher than 1,848 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 NCT00000678, the US trial registry maintained by the National Library of Medicine. NCT00000678 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.