Trial Outcomes & Findings for MMF for HIV Reservoir Reduction (NCT NCT03262441)
NCT ID: NCT03262441
Last Updated: 2020-12-03
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
12 months
Results posted on
2020-12-03
Participant Flow
Participants were recruited from the University of Washington AIDS Clinical Trials Unit at Harborview Medical Center in Seattle. The first participant enrolled February 12, 2018 and the last participant enrolled in August 14, 2018.
Participant milestones
| Measure |
Mycophenolate Mofetil
Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months
Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Mycophenolate Mofetil
Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months
Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
MMF for HIV Reservoir Reduction
Baseline characteristics by cohort
| Measure |
Mycophenolate Mofetil
n=5 Participants
Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months
Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsRegression 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
Outcome measures
| Measure |
Mycophenolate Mofetil
n=4 Participants
Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months
Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months
|
|---|---|
|
Change in Cell-associated HIV DNA (Ca-DNA) Levels Per 10^6 T Cells Over 12 Months
|
-0.00033 log10 caDNA copies per 10^6 T-cells/week
Interval -0.002 to 0.0014
|
PRIMARY outcome
Timeframe: 12 monthsRegression slope of change in cell-associated HIV DNA (ca-DNA) as measured by multiplexed digital droplet PCR in study participants on MMF calculated from 3 time points between 0 \& 12 months
Outcome measures
| Measure |
Mycophenolate Mofetil
n=4 Participants
Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months
Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months
|
|---|---|
|
Change in Cell-associated HIV DNA (Ca-DNA) Levels Per 10^6 Effector Memory CD4+ T Cells Over 12 Months
|
0.001 log10 caDNA copies per 10^6 T-cells/week
Interval -0.0036 to 0.0056
|
PRIMARY outcome
Timeframe: 12 monthsRegression slope of change in cell-associated intact HIV DNA (ca-iDNA) as measured by multiplexed digital droplet PCR in study participants on MMF calculated from 4 time points between 0 \& 12 months
Outcome measures
| Measure |
Mycophenolate Mofetil
n=4 Participants
Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months
Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months
|
|---|---|
|
Change in Cell-associated Intact HIV DNA (Ca-iDNA) Levels Per 10^6 T Cells Over 12 Months
|
.0024 log10 caDNA copies per 10^6 T-cells/week
Interval -0.003 to 0.0078
|
SECONDARY outcome
Timeframe: 12 monthsFrequency of participants with any time point with \<200 CD4+ T cells per mm\^3 from 4 sampled time points between 0 \& 12 months
Outcome measures
| Measure |
Mycophenolate Mofetil
n=4 Participants
Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months
Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months
|
|---|---|
|
Blood CD4+ T Cells Per mm^3 Blood
|
0 participants
|
SECONDARY outcome
Timeframe: 12 monthsNumber of participants experiencing opportunistic infection
Outcome measures
| Measure |
Mycophenolate Mofetil
n=4 Participants
Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months
Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months
|
|---|---|
|
Incidence of Opportunistic Infection
|
0 participants
|
Adverse Events
Mycophenolate Mofetil
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mycophenolate Mofetil
n=5 participants at risk
Mycophenolate Mofetil 500mg Tablets once per day for one week as a lead in to limit drug-related side effects. Provided they are tolerating the drug at lower dose, they will then initiate Mycophenolate Mofetil 500mg Tablets twice daily orally for 22 months
Mycophenolate Mofetil 500Mg Tab: 500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months
|
|---|---|
|
Skin and subcutaneous tissue disorders
Finger cellulitis
|
20.0%
1/5 • Number of events 1 • 20 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Joshua Schiffer
Fred Hutchinson Cancer Research Center
Phone: (206)667-7359
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place