Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00000851 record still lists
NCT00000851 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% higher).
The record links to 0 conditions, and to 2 interventions - of which Stavudine is the first listed.
NCT00000851 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000851's enrollment target sits among peer trials
198 349th of 2000 higher than 1,652 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
- NCT05203328 · 198 participants · NA
Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care During EBUS Bronchoscopy
- NCT05426967 · 198 participants · NA
rTMS for Military TBI-related Depression
- NCT05561114 · 198 participants · Phase 3
Paclitaxel Coated Balloon for the Treatment of Chronic bEnigN sTricture- Esophagus
- NCT05585190 · 198 participants · NA
Stand Up for Your Health with a Sit-stand Desk