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NCT00105417 · ClinicalTrials.gov registry record · Phase 1
Interluekin-7 to Treat HIV-Infected People Receiving Antiretroviral Treatment
A Phase 1 study of HIV Infections and HIV, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00105417 is a Phase 1 study of HIV Infections and HIV that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 20 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00105417, a Phase 1 study of HIV Infections and HIV, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will evaluate whether interleukin-7 (IL-7) a drug similar to the natural IL-7 protein produced by the body, is safe to use in people infected with HIV. IL-7 is important in immune system function. In humans, it can extend the life of immune cells called T-cells and increase their function and maturation; in mice, it can speed up immune system recovery following chemotherapy of transplantation; and in monkeys, it can make T-cells increase in numbers. If this study shows that IL-7 is safe, other trials will determine if it can improve the numbers or function of T-cells in HIV-infected people. Patients 18 years of age and older with HIV infection who have been taking anti-HIV medications for at least 12 months, whose CD4 counts are at least 100 cells/microliter, and whose viral load is no more than 50,000 copies/milliliter may be eligible for this study. Candidates are screened with a physical examination, blood and urine tests, including a blood test for HLA type (a genetic test of markers of the immune system), chest x-ray, electrocardiogram, and ultrasound of the spleen. Participants undergo the following tests and procedures during 9 visits, as follows: Pre-entry visit * Brief physical examination, including examination of lymph nodes and spleen. * Medical history, including questions about current and past medications. * Urine pregnancy test for women who are able to become pregnant. * Blood draw for viral load, immune responses, and other routine safety tests. Entry visit * Complete physical examination, including examination of lymph nodes and spleen. * Routine urine test and urine pregnancy test for women who are able to become pregnant. * Blood draw for viral load, immune responses, and other routine safety tests. * IL-7 dosing. Participants are randomly assigned to receive one of five doses of IL-7 (3, 10, 30, 60 or 100 micrograms per kilogram of body weight) or placebo (a salt solution that does not contain IL-7). The dose may be given in on
Conditions Studied
Interventions
- DRUG IL-7
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-03 |
| Est. Completion | 2006-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00105417
The ClinicalTrials.gov registry entry for NCT00105417 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (96% lower). 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 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which IL-7 is the first listed.
NCT00105417 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00105417 about?
NCT00105417 is a clinical study titled "Interluekin-7 to Treat HIV-Infected People Receiving Antiretroviral Treatment". This study will evaluate whether interleukin-7 (IL-7) a drug similar to the natural IL-7 protein produced by the body, is safe to use in people infected with HIV. IL-7 is important in immune system function. In humans, it can extend the life of immune cells called T-cells and increase their function...
What is the current status of trial NCT00105417?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2005-03. Estimated completion is 2006-05.
What conditions does trial NCT00105417 study?
This clinical trial studies the following conditions: HIV Infections, HIV.
What interventions are being tested in trial NCT00105417?
The interventions under investigation include: IL-7 (DRUG).
Who is sponsoring clinical trial NCT00105417?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00105417 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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