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NCT00001032 · ClinicalTrials.gov registry record · Phase 2
A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
NCT00001032 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 180 participants.
The verdict
NCT00001032, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
Study Summary
PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children. SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory markers of disease progression, as determined by virologic and immunologic determinations. To evaluate the influence of combination therapy on disease progression as determined by evaluation of clinical criteria. In children currently being treated with AZT, it is unknown whether the addition of another antiretroviral agent such as ddC would help increase efficacy and tolerance. This study will examine the possible advantages of combination AZT/ddC therapy over monotherapy with AZT alone.
Interventions
- DRUG Zidovudine
- DRUG Zalcitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Est. Completion | 1995-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001032
The ClinicalTrials.gov registry entry for NCT00001032 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 180 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 Zidovudine is the first listed.
NCT00001032 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001032 about?
NCT00001032 is a clinical study titled "A Study of Dideoxycytidine Plus Zidovudine (AZT) in HIV-Infected Children Who Have Taken AZT". PRIMARY: To determine safety, tolerance, and pharmacokinetics of zidovudine (AZT) and zalcitabine (dideoxycytidine; ddC) when given in combination in clinically stable AZT-treated children. SECONDARY: To compare combination therapy with mono drug therapy for antiviral activity and laboratory marker...
What is the current status of trial NCT00001032?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. Estimated completion is 1995-04.
What interventions are being tested in trial NCT00001032?
The interventions under investigation include: Zidovudine (DRUG), Zalcitabine (DRUG).
Who is sponsoring clinical trial NCT00001032?
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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