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NCT00001267 · ClinicalTrials.gov registry record · Phase 3

A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex With an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine

A Phase 3 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 3
Development phase
42
Enrollment target

NCT00001267: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).

NCT00001267 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 42 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00001267, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 3
Development phase
42 participants
Enrollment target

Study Summary

Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities. This study will involve therapy of patients with AIDS or ARC with two of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles, over a 2-year period of time. The rationale for using the two drugs will be to reduce toxicity and also possibly to delay or prevent the development of resistance. Patients will be randomized to receive either an alternating regimen or a continuous simultaneous regimen with these two drugs. The study will be structured as a randomized pilot study.

Interventions

  • DRUG zidovudine
  • DRUG 2',3'-dideoxyinosine

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 1990-10
Est. Completion 2000-04
Phase Phase 3
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00001267 record still lists

NCT00001267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).

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

NCT00001267 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00001267 about?

NCT00001267 is a clinical study titled "A Randomized Pilot Study for the Treatment of AIDS or AIDS Related Complex With an Alternating or Simultaneous Combination Regimen of AZT and 2',3'-Dideoxyinosine". Several dideoxynucleosides have now been shown to have activity against HIV but to have different toxicities. This study will involve therapy of patients with AIDS or ARC with two of these agents, AZT and 2', 3'-dideoxyinosine (ddI), which have different toxicity profiles, over a 2-year period of ti...

What is the current status of trial NCT00001267?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 1990-10. Estimated completion is 2000-04.

What interventions are being tested in trial NCT00001267?

The interventions under investigation include: zidovudine (DRUG), 2',3'-dideoxyinosine (DRUG).

Who is sponsoring clinical trial NCT00001267?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00001267's enrollment target sits among peer trials

42 1877th of 2000 higher than 124 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00001267, the US trial registry maintained by the National Library of Medicine. NCT00001267 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.