Status:
COMPLETED
MMF for HIV Reservoir Reduction
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
University of Washington
Conditions:
Human Immunodeficiency Virus I Infection
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 p...
Detailed Description
This is an open-label, randomized pilot trial to determine whether MMF given over 22 months meaningfully decreases the size of the HIV reservoir. At the University of Washington in Seattle, investiga...
Eligibility Criteria
Inclusion
- Confirmed HIV infection, by two different positive antibody tests and/or detectable plasma HIV RNA on two different dates
- ≥18 and ≤65 years of age
- Continuous ART during the last two years, with current ART preferably including an integrase inhibitor
- HIV RNA \<40 copies / mL on four occasions during continuous ART of ≥ 2 years with no more than one blip of \<1000 HIV RNA copies / mL
- CD4+ T cell count \> 350/mm3 within the past 365 days
- Karnofsky score ≥80
- Plan to reside in area 2 years
- Consents to study
- Tolerability of MMF during one week dose escalation lead-in phase of 500 mg once daily
- Demonstrated anti-proliferative effect of MMF 500 mg twice daily
Exclusion
- Active malignancy including skin cancer, myelodysplastic syndrome, or myeloproliferative disease within 24 weeks prior to study entry
- Prior organ or bone marrow transplantation
- Diagnosed autoimmune disease
- Medical need for ongoing treatment with an immunosuppressive drug
- Diagnosis of AIDS (defined as any AIDS-defining opportunistic infection or cancer, or a history of blood CD4+ T cell count \< 200/µL)
- Active opportunistic infection
- Using disallowed medications (see 4.3)
- Vomiting or diarrhea which prohibits consistent use of study drugs
- Pregnant, intention to become pregnant, or breastfeeding
- Woman of child bearing age who are NOT using two forms of birth control OR practicing complete abstinence
- Excessive ingestion of ethanol, determined by an AUDIT score of \>8
- Substance abuse
- History of medical non-compliance
- Quantiferon TB positive
- The following laboratory values (\< 30 days before enrollment):
- Hemoglobin \< 8.5 mg/dL
- Absolute neutrophil count \< 1000 cells/mm3
- ALT \> 2 x upper limit of normal
- Platelet count \< 100,000/uL
- Creatinine clearance \< 60 mL/min
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2019
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03262441
Start Date
February 12 2018
End Date
August 31 2019
Last Update
December 3 2020
Active Locations (1)
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1
2 West Clinic at Harborview Medical Center
Seattle, Washington, United States, 98104