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MMF for HIV Reservoir Reduction

NCT03262441 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2020-12-03

Study results available
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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

  • Human Immunodeficiency Virus I Infection

Interventions

DRUG

Mycophenolate Mofetil 500Mg Tab

500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months

Sponsors & Collaborators

Principal Investigators

  • Joshua T Schiffer, MD MSc · Fred Hutchinson Cancer Center

  • Florian Hladik, MD PhD · University of Washington

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-12
Primary Completion
2019-08-31
Completion
2019-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03262441 on ClinicalTrials.gov