Trial Outcomes & Findings for Combination Latency Reversal With High Dose Disulfiram Plus Vorinostat in HIV-infected Individuals on ART (NCT NCT03198559)
NCT ID: NCT03198559
Last Updated: 2024-02-09
Results Overview
The primary endpoint was to determine the change from baseline to day 11 of plasma HIV RNA levels after 11 continuous days of disulfiram with administration of vorinostat on days 8, 9 and 10 in HIV infected individuals on suppressive ART.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Baseline and 11 days
Results posted on
2024-02-09
Participant Flow
Study recruitment began August 8, 2017. Participants were enrolled for screening between this date and when recruitment into the study was suspended on October 19, 2017. In the end, 5 participants were consented into the study and found eligible to begin treatment. Only 2 participants received treatment before the study was suspended.
Enrolled participants who were screened and found eligible to begin on-study treatment were started in a staggered-start. Essentially this meant that the first 2 eligible participants started treatment at the same time. Only once the treatment phase had been completed would the next 2 eligible participants begin the on-study treatment phase.
Participant milestones
| Measure |
Treatment
Participants would receive
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment
Participants would receive
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Combination Latency Reversal With High Dose Disulfiram Plus Vorinostat in HIV-infected Individuals on ART
Baseline characteristics by cohort
| Measure |
Experimental
n=2 Participants
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 11 daysPopulation: The analysis included all participants who received at least one dose of study drug.
The primary endpoint was to determine the change from baseline to day 11 of plasma HIV RNA levels after 11 continuous days of disulfiram with administration of vorinostat on days 8, 9 and 10 in HIV infected individuals on suppressive ART.
Outcome measures
| Measure |
Experimental
n=2 Participants
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Day 11 Plasma HIV RNA Relative to Baseline
Participant 1
|
1 Fold change from baseline to day 11
|
|
Day 11 Plasma HIV RNA Relative to Baseline
Participant 2
|
13.5 Fold change from baseline to day 11
|
SECONDARY outcome
Timeframe: Adverse events were collected continuously throughout the study duration from day 1 on treatment until 2 months since last dose of study drug, an average duration of 3 monthsPopulation: All participants who received one dose of treatment.
This secondary outcome was to determine the Incidence of treatment-emergent adverse events \[Safety and Tolerability\] during a 28 day course of continuous disulfiram with intermittent administration of 3 days of vorinostat on two occasions in HIV infected individuals on suppressive ART. An adverse event is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that; results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, other situations as judged by physician. Systematic assessments of adverse events were performed at each visit, including unscheduled visits
Outcome measures
| Measure |
Experimental
n=2 Participants
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Incidence of Treatment-Emergent Adverse Events
Any SAE
|
2 Participants
|
|
Incidence of Treatment-Emergent Adverse Events
Any non-SAE
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Days 8, 15, 21, 38, 59, 196, 197. Data is reported for days where samples were collected for each participant.Population: All participants who received at least one dose of treatment was analyzed.
This secondary outcome was to determine the fold change in plasma HIV RNA levels at additional time points during and after 11 continuous days of disulfiram with administration of vorinostat on days 8, 9 and 10 in HIV infected individuals on suppressive ART.
Outcome measures
| Measure |
Experimental
n=2 Participants
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Plasma HIV RNA Relative to Baseline at Additional Time Points
Participant 1 - Day 8
|
1 Fold change from baseline
|
|
Plasma HIV RNA Relative to Baseline at Additional Time Points
Participant 1 - Day 59
|
1 Fold change from baseline
|
|
Plasma HIV RNA Relative to Baseline at Additional Time Points
Participant 1 - Day 197
|
1 Fold change from baseline
|
|
Plasma HIV RNA Relative to Baseline at Additional Time Points
Participant 2 - Day 8
|
9.9 Fold change from baseline
|
|
Plasma HIV RNA Relative to Baseline at Additional Time Points
Participant 2 - Day 15
|
14.4 Fold change from baseline
|
|
Plasma HIV RNA Relative to Baseline at Additional Time Points
Participant 2 - Day 21
|
45.9 Fold change from baseline
|
|
Plasma HIV RNA Relative to Baseline at Additional Time Points
Participant 2 - Day 38
|
18.3 Fold change from baseline
|
|
Plasma HIV RNA Relative to Baseline at Additional Time Points
Participant 2 - Day 196
|
5 Fold change from baseline
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Days 8, 11, 15, 21, 38, 59, 196, 197. Data is reported for days where samples were collected for each participant.Population: All participants who had received at least 1 dose of treatment
This secondary outcome was to measure HIV transcription measured by cell-associated unspliced HIV RNA (CA-US HIV RNA) in peripheral blood CD4+ T cells relative to baseline
Outcome measures
| Measure |
Experimental
n=2 Participants
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
HIV RNA Transcription Relative to Baseline at Additional Time Points
Participant 1 - Day 8
|
3.33 Fold change from baseline
|
|
HIV RNA Transcription Relative to Baseline at Additional Time Points
Participant 1 - Day 11
|
5.13 Fold change from baseline
|
|
HIV RNA Transcription Relative to Baseline at Additional Time Points
Participant 1 - Day 59
|
4.56 Fold change from baseline
|
|
HIV RNA Transcription Relative to Baseline at Additional Time Points
Participant 1 - Day 197
|
12.72 Fold change from baseline
|
|
HIV RNA Transcription Relative to Baseline at Additional Time Points
Participant 2 - Day 8
|
1.56 Fold change from baseline
|
|
HIV RNA Transcription Relative to Baseline at Additional Time Points
Participant 2 - Day 11
|
0.91 Fold change from baseline
|
|
HIV RNA Transcription Relative to Baseline at Additional Time Points
Participant 2 - Day 15
|
0.64 Fold change from baseline
|
|
HIV RNA Transcription Relative to Baseline at Additional Time Points
Participant 2 - Day 21
|
0.72 Fold change from baseline
|
|
HIV RNA Transcription Relative to Baseline at Additional Time Points
Participant 2 - Day 38
|
0.41 Fold change from baseline
|
|
HIV RNA Transcription Relative to Baseline at Additional Time Points
Participant 2 - Day 196
|
3.77 Fold change from baseline
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Days 38, 59, 196 and 197. Data is reported for days where results are available for each participant.Population: All participants who received at least one dose of treatment
This outcome was to measure Cell-associated total and integrated HIV DNA in peripheral blood CD4+ T cells relative to baseline
Outcome measures
| Measure |
Experimental
n=2 Participants
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Cell Associated Total HIV DNA Relative to Baseline at Additional Points
Participant 1 - Day 59
|
0.7 Fold change from baseline
|
|
Cell Associated Total HIV DNA Relative to Baseline at Additional Points
Participant 1 - Day 197
|
0.72 Fold change from baseline
|
|
Cell Associated Total HIV DNA Relative to Baseline at Additional Points
Participant 2 - Day 38
|
0.74 Fold change from baseline
|
|
Cell Associated Total HIV DNA Relative to Baseline at Additional Points
Participant 2 - Day 196
|
1.72 Fold change from baseline
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Days 38, 59, 197, 196. Data is reported for days where samples were collected for each participant.Population: All participants who received at least one dose of treatment
This outcome was to measure cell-associated integrated HIV DNA in peripheral blood CD4+ T cells relative to baseline
Outcome measures
| Measure |
Experimental
n=2 Participants
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Cell-associated Integrated HIV DNA Relative to Baseline at Additional Points
Participant 1 - Day 59
|
1.47 Fold change from baseline
|
|
Cell-associated Integrated HIV DNA Relative to Baseline at Additional Points
Participant 1 - Day 197
|
2.52 Fold change from baseline
|
|
Cell-associated Integrated HIV DNA Relative to Baseline at Additional Points
Participant 2 - Day 38
|
0.37 Fold change from baseline
|
|
Cell-associated Integrated HIV DNA Relative to Baseline at Additional Points
Participant 2 -Day 196
|
1.46 Fold change from baseline
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 56Population: This primary endpoint was not performed. See outcome measure description for reasoning
This outcome was to measure the frequency of inducible virus as measured by Tat/rev limiting dilution assay (TILDA) in peripheral blood CD4+ T cells relative to baseline. Not conducted as part of the analysis and there are no future plans to assess this outcome, as analysis from 2 participants would not provide any meaningful results, given that the participants did not manage to complete the treatment course.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and days 8, 11, 15, 21, 37, 58. Data is reported for days where samples were collected for each participant.Population: All participants who received at least one dose of treatment.
This outcome was to measure the concentrations of vorinostat (including its metabolites) in plasma.
Outcome measures
| Measure |
Experimental
n=2 Participants
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Vorinostat Concentration in Plasma
Participant 1 - Baseline
|
NA ng/mL
Concentration was below limit of detection for assay (\<2.00 ng/mL)
|
|
Vorinostat Concentration in Plasma
Participant 1 - Day 8
|
NA ng/mL
Concentration was below limit of detection for assay (\<2.00 ng/mL)
|
|
Vorinostat Concentration in Plasma
Participant 1 - Day 11
|
6.52 ng/mL
|
|
Vorinostat Concentration in Plasma
Participant 2 - Day 11
|
7.6 ng/mL
|
|
Vorinostat Concentration in Plasma
Participant - Day 58
|
NA ng/mL
Concentration was below limit of detection for assay (\<2.00 ng/mL)
|
|
Vorinostat Concentration in Plasma
Participant 2 - Baseline
|
NA ng/mL
Concentration was below limit of detection for assay (\<2.00 ng/mL)
|
|
Vorinostat Concentration in Plasma
Participant 2 - Day 8
|
NA ng/mL
Concentration was below limit of detection for assay (\<2.00 ng/mL)
|
|
Vorinostat Concentration in Plasma
Participant 2 - Day 15
|
NA ng/mL
Concentration was below limit of detection for assay (\<2.00 ng/mL)
|
|
Vorinostat Concentration in Plasma
Participant 2 - Day 21
|
NA ng/mL
Concentration was below limit of detection for assay (\<2.00 ng/mL)
|
|
Vorinostat Concentration in Plasma
Participant 2 - Day 38
|
NA ng/mL
Concentration was below limit of detection for assay (\<2.00 ng/mL)
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 8, 11, 22, 25, 28, 56 and 196 Data is reported for days where samples were collected for each participant.Population: All participants who received at least one dose of treatment.
This outcome was to measure the concentrations of disulfiram (including its metabolites) in plasma
Outcome measures
| Measure |
Experimental
n=2 Participants
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Disulfiram Concentration in Plasma
Participants 1 and 2 - Day 11
|
NA ng/mL
Concentration below limit of detection
|
|
Disulfiram Concentration in Plasma
Participant 1 - Day 58
|
NA ng/mL
Concentration below limit of detection
|
|
Disulfiram Concentration in Plasma
Participant 2 -Day 15
|
NA ng/mL
Concentration below limit of detection
|
|
Disulfiram Concentration in Plasma
Participants 1 and 2 - Day 8
|
NA ng/mL
Concentration below limit of detection
|
|
Disulfiram Concentration in Plasma
Participant 2 - Day 21
|
NA ng/mL
Concentration below limit of detection
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Days 8, 11, 15, 21, 37, 58, 196 and 197. Data is reported for days where samples were collected for each participant.Population: All participants who received at least one dose of treatment.
This outcome was to measure the p24 expression in CD4+ T-cells relative to baseline
Outcome measures
| Measure |
Experimental
n=2 Participants
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
p24 Expression in CD4+ T-cells Relative to Baseline
Participant 2 - Day 196
|
1.39 Fold change from baseline
|
|
p24 Expression in CD4+ T-cells Relative to Baseline
Participant 1 - Day 8
|
0.83 Fold change from baseline
|
|
p24 Expression in CD4+ T-cells Relative to Baseline
Participant 1 - Day 11
|
0.78 Fold change from baseline
|
|
p24 Expression in CD4+ T-cells Relative to Baseline
Participant 1 - Day 58
|
2.13 Fold change from baseline
|
|
p24 Expression in CD4+ T-cells Relative to Baseline
Participant 1 - Day 197
|
0.96 Fold change from baseline
|
|
p24 Expression in CD4+ T-cells Relative to Baseline
Participant 2 - Day 8
|
1.96 Fold change from baseline
|
|
p24 Expression in CD4+ T-cells Relative to Baseline
Participant 2 - Day 11
|
0.91 Fold change from baseline
|
|
p24 Expression in CD4+ T-cells Relative to Baseline
Participant 2 - Day 15
|
1.26 Fold change from baseline
|
|
p24 Expression in CD4+ T-cells Relative to Baseline
Participant 2 - Day 21
|
1 Fold change from baseline
|
|
p24 Expression in CD4+ T-cells Relative to Baseline
Participant 2 - Day 38
|
1.09 Fold change from baseline
|
Adverse Events
Experimental
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Experimental
n=2 participants at risk
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Nervous system disorders
Altered mental status, Grade 3
|
100.0%
2/2 • Adverse event data measured from Day 1 on treatment until two months post last day on treatment, for an average duration of 3 months.
All Serious Adverse Events, and Other Adverse Events (non-serious) have been reported. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening) where known has been added
|
Other adverse events
| Measure |
Experimental
n=2 participants at risk
Participants current ART regimen:
2 grams disulfiram by mouth per day for a total of 28 days
400mg vorinostat by mouth per day on days 8, 9,10 and days 22, 23, 24
Disulfiram, (National Drug Code) NDC 0378-4141-01: This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
Vorinostat, NDC 00006-0568-40: This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
|
|---|---|
|
Nervous system disorders
Lethargy, all grades
|
100.0%
2/2 • Adverse event data measured from Day 1 on treatment until two months post last day on treatment, for an average duration of 3 months.
All Serious Adverse Events, and Other Adverse Events (non-serious) have been reported. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening) where known has been added
|
|
Investigations
Alanine aminotransferase elevated, Grade 1
|
100.0%
2/2 • Adverse event data measured from Day 1 on treatment until two months post last day on treatment, for an average duration of 3 months.
All Serious Adverse Events, and Other Adverse Events (non-serious) have been reported. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening) where known has been added
|
|
Gastrointestinal disorders
Diarrhea, grade 1
|
50.0%
1/2 • Adverse event data measured from Day 1 on treatment until two months post last day on treatment, for an average duration of 3 months.
All Serious Adverse Events, and Other Adverse Events (non-serious) have been reported. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening) where known has been added
|
|
Investigations
Hematuria, grade 1
|
50.0%
1/2 • Adverse event data measured from Day 1 on treatment until two months post last day on treatment, for an average duration of 3 months.
All Serious Adverse Events, and Other Adverse Events (non-serious) have been reported. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening) where known has been added
|
|
Nervous system disorders
Dysgeusia, grade 1
|
50.0%
1/2 • Adverse event data measured from Day 1 on treatment until two months post last day on treatment, for an average duration of 3 months.
All Serious Adverse Events, and Other Adverse Events (non-serious) have been reported. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening) where known has been added
|
|
General disorders
Flu like symptoms, grade 2
|
50.0%
1/2 • Adverse event data measured from Day 1 on treatment until two months post last day on treatment, for an average duration of 3 months.
All Serious Adverse Events, and Other Adverse Events (non-serious) have been reported. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening) where known has been added
|
|
Cardiac disorders
thrombosis or embolism, grade 2
|
50.0%
1/2 • Adverse event data measured from Day 1 on treatment until two months post last day on treatment, for an average duration of 3 months.
All Serious Adverse Events, and Other Adverse Events (non-serious) have been reported. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening) where known has been added
|
|
General disorders
Fatigue, all grades
|
100.0%
2/2 • Adverse event data measured from Day 1 on treatment until two months post last day on treatment, for an average duration of 3 months.
All Serious Adverse Events, and Other Adverse Events (non-serious) have been reported. Any abnormality was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening) where known has been added
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place