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NCT00001074 · ClinicalTrials.gov registry record · Phase 1
The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 140
- Enrollment target
NCT00001074 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 140 participants.
The verdict
NCT00001074, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 140 participants
- Enrollment target
Study Summary
To determine the safety and tolerability of hydroxyurea at two doses alone and in combination with didanosine (ddI). To compare the short term antiviral effect of ddI monotherapy versus hydroxyurea plus ddI, as measured by plasma RNA levels at 8 weeks of therapy. \[AS PER AMENDMENT 10/1/97: Accrual to arms involving hydroxyurea alone has been closed.\] Current antiviral therapies for HIV-1 are limited by a few choices, and the lack of sustained clinical benefit from the drugs. The mechanisms that account for the lack of prolonged inhibition of viral replication by these agents are not fully understood. The activity of RT inhibitors might be potentiated by inhibiting host cellular enzymes essential for efficient HIV reverse transcription. Based on this information, comparisons of the antiviral effects of ddI monotherapy and hydroxyurea plus ddI, with the cellular enzyme ribonucleotide reductase as a potential target, should be done.
Interventions
- DRUG Hydroxyurea
- DRUG Didanosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Est. Completion | 2000-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001074
The ClinicalTrials.gov registry entry for NCT00001074 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hydroxyurea is the first listed.
NCT00001074 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001074 about?
NCT00001074 is a clinical study titled "The Safety and Effectiveness of Hydroxyurea and ddI Used Individually or Together in HIV-Infected Patients". To determine the safety and tolerability of hydroxyurea at two doses alone and in combination with didanosine (ddI). To compare the short term antiviral effect of ddI monotherapy versus hydroxyurea plus ddI, as measured by plasma RNA levels at 8 weeks of therapy. \[AS PER AMENDMENT 10/1/97: Accrual ...
What is the current status of trial NCT00001074?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 140 participants. Estimated completion is 2000-01.
What interventions are being tested in trial NCT00001074?
The interventions under investigation include: Hydroxyurea (DRUG), Didanosine (DRUG).
Who is sponsoring clinical trial NCT00001074?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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