Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00000657 · ClinicalTrials.gov registry record · Phase 2

Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex

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

Completed
Registry status
Phase 2
Development phase
80
Enrollment target

NCT00000657: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000657 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00000657, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target

Study Summary

To compare the safety and effectiveness of orally administered didanosine (ddI) with high dose orally administered zidovudine (AZT) in patients who develop or exhibit progression of the AIDS dementia complex (ADC) and who have not previously been intolerant to AZT at doses of up to 1000 mg/day. HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC may be caused by some action of the AIDS virus on the nervous system, although similar problems can be caused by other infections because the AIDS virus lowers the body's ability to fight other infections. It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions. AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients. Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC.

Interventions

  • DRUG Zidovudine
  • DRUG Didanosine

Trial Details

FieldValue
Enrollment Target 80 participants
Est. Completion 1992-09
Phase Phase 2

What the finished NCT00000657 record still lists

NCT00000657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

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

NCT00000657 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000657 about?

NCT00000657 is a clinical study titled "Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex". To compare the safety and effectiveness of orally administered didanosine (ddI) with high dose orally administered zidovudine (AZT) in patients who develop or exhibit progression of the AIDS dementia complex (ADC) and who have not previously been intolerant to AZT at doses of up to 1000 mg/day. HIV...

What is the current status of trial NCT00000657?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. Estimated completion is 1992-09.

What interventions are being tested in trial NCT00000657?

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

Who is sponsoring clinical trial NCT00000657?

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 NCT00000657's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT01243931 · 80 participants · NA

    Optical Coherence Tomography Guided Transepithelial Phototherapeutic Keratectomy

  • NCT01659203 · 80 participants · Phase 1

    Proton or Photon RT for Retroperitoneal Sarcomas

  • NCT01803451 · 80 participants · Early Phase 1

    Glucagon-like Peptide 1, Glucose Metabolism and Gastric Bypass

  • NCT01964859 · 80 participants · Phase 2

    Feasibility Study for Fibroblast Autologous Skin Grafts

Source: ClinicalTrials.gov NCT00000657, the US trial registry maintained by the National Library of Medicine. NCT00000657 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.