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NCT00001108 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
NCT00001108 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 6 participants.
The verdict
NCT00001108, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
Study Summary
The purpose of this study is to see if 7 drugs, some of them given at higher doses than normal, are safe and tolerated by young patients with AIDS who have failed to respond to other treatments. The study will also see what effect taking several anti-HIV drugs together at high doses has on the body's ability to fight HIV infection. The 7 drugs that will be given in this study are stavudine (d4T), didanosine (ddI), lamivudine (3TC), nelfinavir (NFV), ritonavir (RTV), saquinavir (SQV), and nevirapine (NVP). (This study has been changed from an 8-drug regimen to a 7-drug regimen. Patients no longer receive the drug hydroxyurea \[HU\].) Doctors are seeing many HIV-positive children who did not get good long-term results from the current anti-HIV drugs. Some doctors believe anti-HIV drugs fail because drug levels in the body are too low. In this study, doctors will give patients 7 drugs, some at higher doses than normal. Since it is very important that patients on the study take all of these drugs, doctors will make it as easy as possible. Doctors want to try this because children with advanced AIDS have few treatment choices.
Interventions
- DRUG Lamivudine
- DRUG Ritonavir
- DRUG Nelfinavir mesylate
- DRUG Nevirapine
- DRUG Saquinavir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Est. Completion | 2000-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001108
The ClinicalTrials.gov registry entry for NCT00001108 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 6 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 5 interventions - of which Lamivudine is the first listed.
NCT00001108 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001108 about?
NCT00001108 is a clinical study titled "A Study of the Safety and Effectiveness of Treating Advanced AIDS Patients Between Ages 4 and 22 With 7 Drugs, Some at Higher Than Usual Doses". The purpose of this study is to see if 7 drugs, some of them given at higher doses than normal, are safe and tolerated by young patients with AIDS who have failed to respond to other treatments. The study will also see what effect taking several anti-HIV drugs together at high doses has on the body'...
What is the current status of trial NCT00001108?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 6 participants. Estimated completion is 2000-06.
What interventions are being tested in trial NCT00001108?
The interventions under investigation include: Lamivudine (DRUG), Ritonavir (DRUG), Nelfinavir mesylate (DRUG), Nevirapine (DRUG), Saquinavir (DRUG).
Who is sponsoring clinical trial NCT00001108?
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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