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NCT00002230 · ClinicalTrials.gov registry record · Phase 3

A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients

A Phase 3 study, sponsored by Northwestern University.

Completed
Registry status
Phase 3
Development phase
100
Enrollment target

NCT00002230: Completed Phase 3 study, sponsored by Northwestern University.

NCT00002230 is a Phase 3 study that has completed, run by Northwestern University. The registered enrollment target is 100 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00002230, a Phase 3 study, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
Phase 3
Development phase
100 participants
Enrollment target

Study Summary

To determine the virologic benefits associated with the addition of hydroxyurea (HU) to combination drug therapy with didanosine (ddI), stavudine (d4T), and efavirenz (DMP) in HIV-infected patients. To assess the safety and tolerance of this regimen, with or without HU.

Interventions

  • DRUG Hydroxyurea
  • DRUG Efavirenz
  • DRUG Stavudine
  • DRUG Didanosine

Trial Details

FieldValue
Enrollment Target 100 participants
Phase Phase 3
Northwestern University

1,209 total trials

What the finished NCT00002230 record still lists

NCT00002230 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 4 interventions - of which Hydroxyurea is the first listed.

NCT00002230 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00002230 about?

NCT00002230 is a clinical study titled "A Randomized, Placebo-Controlled Study of the Safety and Efficacy of Efavirenz, Didanosine, and Stavudine in Combination With or Without Hydroxyurea in Antiretroviral Naive or Experienced HIV-Infected Patients". To determine the virologic benefits associated with the addition of hydroxyurea (HU) to combination drug therapy with didanosine (ddI), stavudine (d4T), and efavirenz (DMP) in HIV-infected patients. To assess the safety and tolerance of this regimen, with or without HU.

What is the current status of trial NCT00002230?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 100 participants.

What interventions are being tested in trial NCT00002230?

The interventions under investigation include: Hydroxyurea (DRUG), Efavirenz (DRUG), Stavudine (DRUG), Didanosine (DRUG).

Who is sponsoring clinical trial NCT00002230?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

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How this trial's enrollment target compares

Where NCT00002230's enrollment target sits among peer trials

100 1681st of 2000 higher than 288 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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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT00002230, the US trial registry maintained by the National Library of Medicine. NCT00002230 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.