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NCT01295515 · ClinicalTrials.gov registry record · Phase 1
Interferon Alpha 2b Intensification in HIV-Positive Individuals on Antiretroviral Therapy
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01295515: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01295515 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01295515, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: * Antiretroviral therapy (ART) has been able to improve the lifespan of individuals infected with human immunodeficiency virus type 1 (HIV-1), but ART requires continuous treatment that has substantial consequences on quality of life. Recent research is attempting to determine whether this persistent infection stems from a low-level infection where new cells are continually infected with HIV, or from cells that live for a long time after infection. ART is very active against the virus in new cells, but has no effect on long-lived cells that are already infected with HIV-1 at the start of ART. As a result, new strategies may be necessary to reduce or eradicate these 'reservoir' cells. * Interferon is a natural substance made by the body to combat virus infections, and can be made as an injectable drug known as PEGINTRON. Researchers are interested in determining whether PEGINTRON therapy will also reduce the residual low levels of HIV in patients who are already taking ART. Objectives: \- To evaluate the effectiveness of PEGINTRON injections on HIV levels in participants currently undergoing antiretroviral therapy. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with HIV, are currently undergoing antiretroviral therapy, and have maintained HIV virus blood counts that are not detectable by current commercial tests for at least 12 months before the start of the study. Design: * This study will involve separate screening and treatment processes. * Participants will be screened with a physical examination and medical history, including blood and urine samples. The screening analysis to determine study eligibility will take several weeks. Participants will have apheresis to provide sufficient numbers of blood cells for evaluation by the study researchers. * Eligible participants will begin a 4-week course of PEGINTRON injections using the standard dose of PEGINTRON that is approved for treatment of chronic hepatitis C. Parti
Interventions
- DRUG Pegylated Interferon Alpha 2b (PEGINTRON)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-02-11 |
| Est. Completion | 2017-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01295515
The ClinicalTrials.gov registry entry for NCT01295515 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pegylated Interferon Alpha 2b (PEGINTRON) is the first listed.
NCT01295515 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01295515 about?
NCT01295515 is a clinical study titled "Interferon Alpha 2b Intensification in HIV-Positive Individuals on Antiretroviral Therapy". Background: * Antiretroviral therapy (ART) has been able to improve the lifespan of individuals infected with human immunodeficiency virus type 1 (HIV-1), but ART requires continuous treatment that has substantial consequences on quality of life. Recent research is attempting to determine whether t...
What is the current status of trial NCT01295515?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2011-02-11. Estimated completion is 2017-05-31.
What interventions are being tested in trial NCT01295515?
The interventions under investigation include: Pegylated Interferon Alpha 2b (PEGINTRON) (DRUG).
Who is sponsoring clinical trial NCT01295515?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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