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NCT03262441 · ClinicalTrials.gov registry record · Phase 2
MMF for HIV Reservoir Reduction
A Phase 2 study of Human Immunodeficiency Virus I Infection, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT03262441 is a Phase 2 study of Human Immunodeficiency Virus I Infection that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 5 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03262441, a Phase 2 study of Human Immunodeficiency Virus I Infection, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label, randomized Phase II study to determine whether Mycophenolate mofetil (MMF) given over 22 months meaningfully decreases the size of participants' HIV reservoir. In addition to primary safety endpoints, the following hypotheses regarding drug efficacy will be tested: 1. MMF will be well tolerated and will not decrease adherence to or antiviral efficacy of ART. 2. Peripheral CD4+ T-cell counts and percentages will not meaningfully decrease during treatment with MMF and ART. 3. There will be no excess risk of opportunistic infections in MMF-treated study participants. 4. MMF therapy will lead to a progressive decrease in reservoir size over 22 months of treatment. 5. MMF therapy will lead to a continual shift in HIV reservoir composition from primarily effector memory CD4+ T cells (TEM) and central memory CD4+ T cells (TCM), to primarily stem cell like memory (TSCM) and naïve (TN) CD4+ T cells. 6. MMF will eliminate detectable measures of the HIV reservoir, including by cell-associated DNA/mRNA and quantitative viral outgrowth. 7. MMF will not decrease the humoral immune response to routine annual influenza vaccination.
Conditions Studied
Interventions
- DRUG Mycophenolate Mofetil 500Mg Tab
Study Locations (1)
Washington
- 2 West Clinic at Harborview Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2018-02-12 |
| Est. Completion | 2019-08-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03262441
The ClinicalTrials.gov registry entry for NCT03262441 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Human Immunodeficiency Virus I Infection appearing as the primary indexed condition, and to 1 intervention - of which Mycophenolate Mofetil 500Mg Tab is the first listed.
NCT03262441 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT03262441 about?
NCT03262441 is a clinical study titled "MMF for HIV Reservoir Reduction". This is an open label, randomized Phase II study to determine whether Mycophenolate mofetil (MMF) given over 22 months meaningfully decreases the size of participants' HIV reservoir. In addition to primary safety endpoints, the following hypotheses regarding drug efficacy will be tested: 1. MMF wi...
What is the current status of trial NCT03262441?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2018-02-12. Estimated completion is 2019-08-31.
What conditions does trial NCT03262441 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus I Infection.
What interventions are being tested in trial NCT03262441?
The interventions under investigation include: Mycophenolate Mofetil 500Mg Tab (DRUG).
Who is sponsoring clinical trial NCT03262441?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03262441 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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