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NCT00000814 · ClinicalTrials.gov registry record · Phase 1

A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
390
Enrollment target

NCT00000814: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000814 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 390 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (550% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000814, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
390 participants
Enrollment target

Study Summary

To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection. The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to the drug. Use of combination antiretroviral therapy can potentially reduce viral load and prevent emergence of multidrug resistance.

Interventions

  • DRUG Zidovudine
  • DRUG Didanosine
  • DRUG Nevirapine

Trial Details

FieldValue
Enrollment Target 390 participants
Est. Completion 1998-11
Phase Phase 1

What the finished NCT00000814 record still lists

NCT00000814 is an interventional study that assigns participants to a tested intervention. The registered 390 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (550% higher).

The record links to 0 conditions, and to 3 interventions - of which Zidovudine is the first listed.

NCT00000814 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000814 about?

NCT00000814 is a clinical study titled "A Comparative Study of Combination Antiretroviral Therapy in Children and Adolescents With Advanced HIV Disease". To compare the antiviral activity, safety, toxicity, and steady-state pharmacokinetics of zidovudine, didanosine, and nevirapine used in combination in patients with HIV infection. The duration of clinical benefit from zidovudine (AZT) may be limited because of development of viral resistance to th...

What is the current status of trial NCT00000814?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 390 participants. Estimated completion is 1998-11.

What interventions are being tested in trial NCT00000814?

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

Who is sponsoring clinical trial NCT00000814?

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 NCT00000814's enrollment target sits among peer trials

390 78th of 2000 higher than 1,922 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00000814, the US trial registry maintained by the National Library of Medicine. NCT00000814 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.