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MMF for HIV Reservoir Reduction
NCT03262441 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 319 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03262441 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03262441?
The interventions under investigation include: Mycophenolate Mofetil 500Mg Tab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03262441?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 319 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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