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NCT00001066 · ClinicalTrials.gov registry record · Phase 2
A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 740
- Enrollment target
NCT00001066: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00001066 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 740 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (456% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001066, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 740 participants
- Enrollment target
Study Summary
To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC/AZT in this patient population. To determine other measures of diseases in response to the study regimens. Currently, none of the potential treatments for HIV-1 infection has proven to be both nontoxic and effective in long-term use. However, previous studies in both adults and children have shown that 3TC combined with AZT reduced HIV load in blood and increased white blood cells. Additionally, 3TC has demonstrated a favorable safety profile.
Interventions
- DRUG Zidovudine
- DRUG Lamivudine
- DRUG Didanosine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 740 participants |
| Phase | Phase 2 |
What the finished NCT00001066 record still lists
NCT00001066 is an interventional study that assigns participants to a tested intervention. The registered 740 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 (456% higher).
The record links to 0 conditions, and to 3 interventions - of which Zidovudine is the first listed.
NCT00001066 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00001066 about?
NCT00001066 is a clinical study titled "A Comparison of Zidovudine Plus Lamivudine Versus ddI Used Alone or in Combination With Zidovudine in HIV-1 Infected Children". To compare the efficacy of lamivudine (3TC) and zidovudine (AZT) in combination versus the better of didanosine (ddI) monotherapy or ddI/AZT combination, in symptomatic HIV-1 infected children who received less than 56 days of prior antiretroviral therapy. To evaluate the safety and tolerance of 3TC...
What is the current status of trial NCT00001066?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 740 participants.
What interventions are being tested in trial NCT00001066?
The interventions under investigation include: Zidovudine (DRUG), Lamivudine (DRUG), Didanosine (DRUG).
Who is sponsoring clinical trial NCT00001066?
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 NCT00001066's enrollment target sits among peer trials
740 44th of 2000 higher than 1,956 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
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