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NCT02071095 · ClinicalTrials.gov registry record · Phase 1
Enhancement by Poly-ICLC During HIV-1 Infection
A Phase 1 study, sponsored by Nina Bhardwaj.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT02071095 is a Phase 1 study that has completed, run by Nina Bhardwaj. The registered enrollment target is 15 participants.
The verdict
NCT02071095, a Phase 1 study, has completed, sponsored by Nina Bhardwaj.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This study involves researching new approaches to treating HIV infection. Currently, HIV infection is treated with combinations of drugs called antiretrovirals. These drugs protect cells from infection by interfering with the viruses' ability to make copies of itself by infecting new target cells. Though these drugs are very effective, they cannot cure HIV infection and must be taken each and every day at prescribed doses to maintain their beneficial effect. This research study is investigating a new approach that involves an addition to existing medications. The study is investigating a medication called Poly-ICLC (Hiltonol®, Oncovir), which is an adjuvant. Adjuvants are medications that are designed to boost your body's immune responses resulting from a vaccine. The investigators want to test whether Poly-ICLC is an adjuvant that is effective in HIV-infected patients. A vaccine is not given in this study, but just investigating the adjuvant, Poly-ICLC, to determine whether it may be safe and useful in future vaccines that could be used to treat HIV, called therapeutic vaccines. One goal of future therapeutic vaccines is to reduce the virus that remains persistently inside of cells in a dormant or resting state despite treatment with HIV medications. This persistent pool is termed the "latent virus pool" or "viral reservoir". One tactic to reduce this viral reservoir is to first stimulate HIV to start replicating in order to force it out of hiding. Once viral replication occurs, the infected cells may then be recognized and killed by cells of the immune system. Therefore, we also want to see what effect Poly-ICLC has on the virus that lives inside of cells. Specifically, the investigators want to look at whether Poly-ICLC increases the level of virus inside your cells while also improving your immune system's responses. The investigators are doing this research in hope to find new ways to treat HIV infection that may reduce exposure to medications that are called
Interventions
- DRUG Arm A: Poly-ICLC
- DRUG Arm B: Normal Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-07-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02071095
The ClinicalTrials.gov registry entry for NCT02071095 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nina Bhardwaj, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Arm A: Poly-ICLC is the first listed.
NCT02071095 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02071095 about?
NCT02071095 is a clinical study titled "Enhancement by Poly-ICLC During HIV-1 Infection". This study involves researching new approaches to treating HIV infection. Currently, HIV infection is treated with combinations of drugs called antiretrovirals. These drugs protect cells from infection by interfering with the viruses' ability to make copies of itself by infecting new target cells. T...
What is the current status of trial NCT02071095?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2014-04. Estimated completion is 2016-07-26.
What interventions are being tested in trial NCT02071095?
The interventions under investigation include: Arm A: Poly-ICLC (DRUG), Arm B: Normal Saline (DRUG).
Who is sponsoring clinical trial NCT02071095?
This trial is sponsored by Nina Bhardwaj, which has 7 total clinical trials registered on ClinicalTrials.gov.
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