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NCT00000772 · ClinicalTrials.gov registry record · Phase 1

A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals

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

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT00000772: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000772 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000772, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

To evaluate the safety and tolerance of concurrent administration of standard-dose didanosine (ddI) with low-dose ribavirin in HIV-positive patients. To determine the pharmacokinetic interactions of concurrent administration of ddI and ribavirin and correlate pharmacokinetic parameters with toxicity. To investigate antiviral activity of the combined regimen. Combination ddI/ribavirin therapy, if safe and effective, offers an alternative combination antiretroviral regimen for patients unable to tolerate regimens containing zidovudine (AZT).

Interventions

  • DRUG Didanosine
  • DRUG Ribavirin

Trial Details

FieldValue
Enrollment Target 15 participants
Est. Completion 1995-02
Phase Phase 1

What the finished NCT00000772 record still lists

NCT00000772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

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

NCT00000772 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000772 about?

NCT00000772 is a clinical study titled "A Phase I Open-Label Study of the Safety, Tolerance, and Pharmacokinetic Interactions of Combination Didanosine and Ribavirin in HIV-Positive Individuals". To evaluate the safety and tolerance of concurrent administration of standard-dose didanosine (ddI) with low-dose ribavirin in HIV-positive patients. To determine the pharmacokinetic interactions of concurrent administration of ddI and ribavirin and correlate pharmacokinetic parameters with toxicity...

What is the current status of trial NCT00000772?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. Estimated completion is 1995-02.

What interventions are being tested in trial NCT00000772?

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

Who is sponsoring clinical trial NCT00000772?

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 NCT00000772's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 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 NCT00000772, the US trial registry maintained by the National Library of Medicine. NCT00000772 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.