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NCT00000851 · ClinicalTrials.gov registry record · Phase 2
Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 198
- Enrollment target
NCT00000851 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 198 participants.
The verdict
NCT00000851, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 198 participants
- Enrollment target
Study Summary
To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from baseline in plasma HIV RNA concentrations. To determine the relationship, if any, between drug exposure and viral burden. In a pilot study of d4T and ddI given to eight children with advanced HIV for 24 weeks, the three children with baseline counts greater than 50 cells/micro liter experienced a 20% increase in their CD4+ lymphocyte counts. Based on these results, controlled trials of the same regimen for children with less advanced HIV disease should be undertaken.
Interventions
- DRUG Stavudine
- DRUG Didanosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Est. Completion | 1998-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000851
The ClinicalTrials.gov registry entry for NCT00000851 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 198 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 Stavudine is the first listed.
NCT00000851 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00000851 about?
NCT00000851 is a clinical study titled "Comparison of Stavudine Used Alone or in Combination With Didanosine in HIV-Infected Children". To evaluate the safety and determine the pharmacokinetic disposition of stavudine (d4T) alone and in combination with didanosine (ddI), and whether concurrent administration alters the disposition of either drug. To compare d4T versus d4T plus ddI with respect to short and long term changes from bas...
What is the current status of trial NCT00000851?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 198 participants. Estimated completion is 1998-10.
What interventions are being tested in trial NCT00000851?
The interventions under investigation include: Stavudine (DRUG), Didanosine (DRUG).
Who is sponsoring clinical trial NCT00000851?
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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