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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: Completed Phase 2 study of Human Immunodeficiency Virus I Infection, sponsored by Fred Hutchinson Cancer Center.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Regression slope of change in cell-associated HIV DNA (ca-DNA) as measured by multiplexed digital droplet PCR in study participants on MMF calculated from 4 time points between 0 \& 12 months
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 |
What the finished NCT03262441 record still lists
NCT03262441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03262441's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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