Evaluating the Safety and Efficacy of Romidepsin in Combi... | NCT01933594

ID	Type	Description	Link
11892	Registry Identifier	DAIDS-ES
ACTG 5315

Label	Type	Description	Intervention Names
Cohort 1-Arm 1A (Romidepsin)	Experimental	Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of Romidepsin was 0.5 mg/m^2, with total dose based on the participant's body surface area (determined by participant's height and weight).	Drug: Romidepsin
Cohort 1-Arm 1B (Placebo for Romidepsin)	Placebo Comparator	Participants in Cohort 1, Arm 1B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of sodium chloride for injection placebo was 0.5 mg/m^2, with total dose based on the participant's body surface area (determined by participant's height and weight).	Drug: Placebo for Romidepsin
Cohort 2-Arm 2A (Romidepsin)	Experimental	Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of Romidepsin was 2 mg/m^2, with total dose based on the participant's body surface area (determined by participant's height and weight).	Drug: Romidepsin
Cohort 2-Arm 2B (Placebo for Romidepsin)	Placebo Comparator	Participants in Cohort 2, Arm 2B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. Dose of sodium chloride for injection placebo was 2 mg/m^2, with total dose based on the participant's body surface area (determined by participant's height and weight).

Name	Type	Description	Arm Group Labels	Other Names
Romidepsin	Drug	RMD administered over 4 hours via an intravenous (IV) catheter.	Cohort 1-Arm 1A (Romidepsin) Cohort 2-Arm 2A (Romidepsin) Cohort 3-Arm 3A (Romidepsin)

Measure	Description	Time Frame
Proportion of Participants With Grade 3 or Higher Adverse Events (AEs) in Cohorts 1-3 Romidepsin Arms	Proportion of participants with Grade 3 or higher adverse events (AEs) in Cohorts 1-3 Romidepsin Arms, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used.	Measured from the time of Romidepsin administration (at entry) until 28 days after the administration
Proportion of Participants With Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm	Proportion of participants with Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used.	Measured from the time of the first Romidepsin administration through 28 days after the last administration (at day 42)
Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohorts 1-3	Baseline is defined as the average of the pre-entry and entry values. Hour 24/48 is defined as the average of values at 24 and 48 hours after the single administration of Romidepsin or placebo (at study entry). Change was calculated as the value at hour 24/48 minus the value at baseline.	Pre-entry, entry, 24 and 48 hours after the single administration of Romidepsin or placebo (at entry)
Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohort 4	Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) minus the value at baseline.	Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)

Measure	Description	Time Frame
Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohorts 1-3	Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 6 hours, 12 hours, 7 days, 14 days and 28 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.	Pre-entry, entry, 6 hours, 12 hours, 7 days, 14 days and 28 days after the single administration of Romidepsin or placebo (at entry)

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Cohorts 1, 2, & 3

HIV-1 infection, documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to study entry & confirmed by a licensed Western blot or a 2nd antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA
Receiving 2 (or more) nucleoside or nucleotide reverse transcriptase inhibitors with raltegravir, dolutegravir, or efavirenz for at least 90 days prior to study entry with no intention to change for the duration of the study
Documentation of at least 2 historical HIV-1 RNA measurements <50 copies/mL while on ART obtained by standard ultrasensitive assay. Documentation of the 1st measurement must be from a result obtained between 365-91 days, inclusive, prior to study entry. Documentation of the 2nd measurement must be from a result obtained between 730-366 days, inclusive, prior to study entry. In addition, there must be no HIV-1 RNA values ≥50 copies/mL for at least 365 days prior to study entry.
CD4 cell count ≥300 cells/mm^3 obtained within 90-50 days prior to study entry at any US laboratory that has a CLIA certification or equivalent
HIV-1 RNA level of <50 copies/mL obtained by standard ultrasensitive assay within 90-50 days prior to study entry
HIV-1 RNA level of ≥0.4 copies/mL obtained by SCA within 90-50 days prior to study entry. This result must be available prior to the pre-entry visit
The following laboratory values obtained within 21-0 days prior to study entry by any laboratory that has a CLIA certification or equivalent
- ANC ≥1500 cells/mm^3
- Hemoglobin ≥12.0 g/dL for men & >11.0 g/dL for women
- Platelet count ≥120,000/mm^3
The following laboratory values obtained within 21-7 days prior to study entry by any laboratory that has a CLIA certification or equivalent
- CrCl ≥60 mL/min
- Potassium & magnesium within normal limits
- AST (SGOT) <2.0 x ULN
- ALT (SGPT) <2.0 x ULN
- Alkaline phosphatase <2.0 x ULN
- Total bilirubin <2.5 x ULN
HCV antibody negative result within 90-50 days prior to study entry or, for study candidates who are HCV antibody positive (based on testing performed at any time prior to study entry), a negative HCV RNA result obtained within 90-50 days prior to study entry
Negative HBsAg result obtained within 90-50 days prior to study entry or a positive HBsAb result at any time prior to study entry
For females of reproductive potential, negative serum or urine pregnancy test (latter with sensitivity of ≤25 mIU/mL) at the screening visit, pre-entry visit within 21-7 days prior to study entry, & at entry prior to romidepsin infusion, by any US laboratory that has a CLIA certification or equivalent
Female candidates of reproductive potential must refrain from participating in active attempts to become pregnant, &, if participating in sexual activity that could lead to pregnancy, must agree to use at least 2 reliable forms of contraception that are non-estrogen based. All female participants of reproductive potential must be instructed to use contraceptives for 6 months/180 days after completing RMD or placebo infusion
Karnofsky performance score ≥80 within 21-7 days prior to study entry
Men and women age ≥ 18 years
Ability & willingness to provide written informed consent
Investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen

Exclusion Criteria: Cohorts 1, 2, & 3

History of or current malignancy requiring cytotoxic therapy
Bacterial, fungal, or viral infection (other than HIV) requiring systemic therapy within 30 days prior to entry
History of or current CMV end organ disease (eg, retinitis)
History of or current AIDS-related syndromes or symptoms that pose a perceived excessive risk for study drug-related morbidity, as determined by the investigator
Chronic, acute, or recurrent infections that are current & serious in the opinion of the investigator & for which the participant has not completed at least 14 consecutive days of therapy within 30 days prior to study entry and/or is not clinically stable
Active autoimmune disorders including but not limited to: inflammatory bowel diseases, scleroderma, severe psoriasis as determined by the investigator, systemic lupus erythematosus, rheumatoid arthritis & optic neuritis
History of seizure disorders
History of anticonvulsant use within 60 days prior to study entry
History of MI within 6 months prior to study entry, history of QTc prolongation (defined as ECG with QTc intervals >450 ms) at any time prior to study entry, NYHA class III or IV heart failure at any time prior to study entry, or family history of prolonged QTc syndrome
Breastfeeding
Use of immunomodulators (eg, interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry
Any vaccination within 30 days prior to entry or intent to receive an elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study
Intent to use cytokines (e.g., IL-2 or IL-12) during the course of the study. Prior administration of cytokines is not an exclusion criterion; however, at least 60 days between the most recent cycle of any cytokine and study entry is required
Within 60 days prior to study entry, use of systemic azole antifungals (voriconazole, itraconazole, ketoconazole); dexamethasone; macrolide antibiotics (azithromycin, clarithromycin, erythromycin); ARVs that are inhibitors of, or are metabolized by, CYP3A4 (atazanavir, ritonavir, nelfinavir, indinavir, saquinavir, darunavir, lopinavir, rilpivirine, maraviroc); cobicistat; warfarin; nefazodone; rifamycins (rifabutin, rifampin, rifapentine); St. John's Wort; carbamazepine; phenytoin; phenobarbital; amiodarone; dofetilide; pimozide; procainamide; quinidine; sotalol; & birth control products containing estrogen; drugs that are p-glycoprotein inhibitors; & drugs that prolong the QTc interval with a risk of Torsades de Pointes
Known allergy, sensitivity, or any hypersensitivity to components of RMD or its formulation
Use of histone deacetylase inhibitors (eg, vorinostat, valproic acid) at any time prior to study entry
Active illicit drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
Acute or serious illness requiring systemic treatment and/or hospitalization that is not resolved within 30 days prior to entry
Psychosocial conditions that would prevent study compliance and follow-up, as determined by the investigator
Documented opportunistic infections within 60 days prior to entry

Inclusion Criteria: Cohort 4, Step 1

HIV-1 infection, documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to study entry & confirmed by a licensed Western blot or a 2nd antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA
Receiving 2 or more nucleoside or nucleotide reverse transcriptase inhibitors with raltegravir or dolutegravir for at least 90 days prior to study entry with no intention to change for the duration of the study
Documentation of at least 2 historical HIV-1 RNA measurements <50 copies/mL while on ART obtained by standard ultrasensitive assay. Documentation of the first measurement must be from a result obtained between 365-61 days, inclusive, prior to study entry. Documentation of the second measurement must be from a result obtained between 730-366 days, inclusive, prior to study entry. In addition, there must be no HIV-1 RNA values ≥50 copies/mL for at least 365 days prior to study entry
CD4 cell count ≥300 cells/mm^3 obtained between 36-60 days prior to study entry (screening visit) at any US laboratory that has a CLIA certification or equivalent
HIV-1 RNA level of <50 copies/mL obtained by standard ultrasensitive assay at screening (between 36-60 days prior to study entry)
The following laboratory values obtained at pre-entry (between 3-14 days prior to study entry) by any laboratory that has a CLIA certification or equivalent
- ANC ≥1500 cells/mm^3
- Hemoglobin ≥12.0 g/dL for men & >11.0 g/dL for women
- Platelet count ≥120,000/mm^3
- CrCl ≥60 mL/min
- Potassium & magnesium within normal limits
- AST (SGOT) <2.0 x ULN
- ALT (SGPT) <2.0 x ULN
- Alkaline phosphatase <2.0 x ULN
- Total bilirubin <2.5 x ULN
HCV antibody negative result at screening (between 36-60 days prior to study entry) or, for study candidates who are HCV antibody positive (based on testing performed at any time prior to study entry), a negative HCV RNA result obtained at screening
Negative HBsAg result obtained at screening (between 36-60 days prior to study entry) or a positive HBsAb result at any time prior to study entry
For females of reproductive potential, negative urine pregnancy test (with a sensitivity of ≤25 mIU/mL) at screening (between 36-60 days prior to study entry), at pre-entry (between 3-14 days prior to study entry), & at entry prior to infusion, by any US laboratory that has a CLIA certification or equivalent
Female candidates of reproductive potential must refrain from participating in active attempts to become pregnant, &, if participating in sexual activity that could lead to pregnancy, must agree to use at least 2 reliable forms of contraception that are non-estrogen based. All participants of reproductive potential will be instructed to use contraceptives for 6 months or 180 days after completing RMD/placebo infusion
Karnofsky performance score ≥80 at pre-entry (between 3-14 days prior to study entry)
Men and women age ≥ 18 years
Ability & willingness to provide written informed consent
Investigator anticipates that a fully active alternative ART regimen could be constructed in the event of virologic failure on the current ART regimen

Exclusion Criteria: Cohort 4, Step 1

History of or current malignancy requiring cytotoxic therapy
Bacterial, fungal or viral infection (other than HIV) requiring systemic therapy within 30 days prior to entry
History of or current CMV end organ disease (eg, retinitis)
History of or current AIDS-related syndromes or symptoms that pose a perceived excessive risk for study drug-related morbidity, as determined by the investigator
Chronic, acute, or recurrent infections that are current & serious, in the opinion of the investigator, for which the participant has not completed at least 14 consecutive days of therapy within 30 days prior to study entry and/or is not clinically stable
Active autoimmune disorders including but not limited to inflammatory bowel diseases, scleroderma, severe psoriasis as determined by the investigator, systemic lupus erythematosus, rheumatoid arthritis, & optic neuritis
History of seizure disorders
History of anticonvulsant use within 60 days prior to study entry
History of MI within 6 months prior to study entry, history of QTc prolongation (defined as ECG with QTc intervals >450 ms) at any time prior to study entry, NYHA class III or IV heart failure at any time prior to study entry, or family history of prolonged QTc syndrome
Breastfeeding
Use of immunomodulators (eg, interleukins, interferons, cyclosporine), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 60 days prior to study entry
Any vaccination within 30 days prior to entry or intent to receive an elective vaccination (eg, flu shot, hepatitis A or B vaccine) during the course of the study
Intent to use cytokines (eg, IL-2 or IL-12) during the course of the study
Within 60 days prior to study entry, use of systemic azole antifungals (voriconazole, itraconazole, ketoconazole), dexamethasone, macrolide antibiotics (azithromycin, clarithromycin, erythromycin), antiretrovirals that are inhibitors of, or are metabolized by CYP3A4 (atazanavir, ritonavir, nelfinavir, indinavir, saquinavir, darunavir, lopinavir, rilpivirine, maraviroc), cobicistat, warfarin, nefazodone, rifamycins (rifabutin, rifampin, rifapentine), St. John's Wort, carbamazepine, phenytoin, phenobarbital, amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, & birth control products containing estrogen, drugs that are p-glycoprotein inhibitors, & drugs that prolong the QTc interval with a risk of Torsades de Pointes
Known allergy/sensitivity or any hypersensitivity to components of RMD or its formulation
Use of histone deacetylase inhibitors (eg, vorinostat, valproic acid) at any time prior to study entry
Active illicit drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
Acute or serious illness requiring systemic treatment and/or hospitalization that is not resolved within 30 days prior to entry
Psychosocial conditions that would prevent study compliance & follow-up as determined by the investigator
Documented opportunistic infections within 60 days prior to entry
Use of any of the medications listed in the Prohibited Medications table in the protocol

See the protocol for Inclusion and Exclusion Criteria for Cohort 4, Steps 2, 3, and 4.

Name	Affiliation	Role
John Mellors, MD	University of Pittsburgh	Study Chair
Deborah McMahon, MD	University of Pittsburgh	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Alabama CRS		Birmingham	Alabama	35294	United States
UCLA CARE Center CRS

PubMed Identifier	Type	Citation	Retractions
15166525	Background	Ylisastigui L, Archin NM, Lehrman G, Bosch RJ, Margolis DM. Coaxing HIV-1 from resting CD4 T cells: histone deacetylase inhibition allows latent viral expression. AIDS. 2004 May 21;18(8):1101-8. doi: 10.1097/00002030-200405210-00003.
18245545	Background	Klimek VM, Fircanis S, Maslak P, Guernah I, Baum M, Wu N, Panageas K, Wright JJ, Pandolfi PP, Nimer SD. Tolerability, pharmacodynamics, and pharmacokinetics studies of depsipeptide (romidepsin) in patients with acute myelogenous leukemia or advanced myelodysplastic syndromes. Clin Cancer Res. 2008 Feb 1;14(3):826-32. doi: 10.1158/1078-0432.CCR-07-0318.

Label	URL
DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014. Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual), Version 2.0, January 2010	View source

ID	Title	Description
FG000	Cohort 1-Arm 1A (Romidepsin)	Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
FG001	Cohort 2-Arm 2A (Romidepsin)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 7, 2018	Apr 3, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Proportion of Participants With Grade 3 or Higher Adverse Events (AEs) in Cohorts 1-3 Romidepsin Arms

Proportion of participants with Grade 3 or higher adverse events (AEs) in Cohorts 1-3 Romidepsin Arms, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used.

Participants in Cohorts 1-3 who received Romidepsin

Posted

Number

95% Confidence Interval

proportion of participants

Measured from the time of Romidepsin administration (at entry) until 28 days after the administration

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants	OG00036

Title

Denominators

Categories

Title	Measurements
	OG0000(0 to 0.097)

Primary

Proportion of Participants With Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm

Proportion of participants with Grade 3 or Higher Adverse Events (AEs) in Cohort 4 Romidepsin Arm, including signs/symptoms, lab toxicities, and /or clinical events probably, possibly, or definitely related to study treatment (as judged by the core team, blinded to treatment arm). The DAIDS AE Grading Table (Version 1.0) was used.

Participants in Cohort 4 who received Romidepsin

Posted

Number

95% Confidence Interval

proportion of participants

Measured from the time of the first Romidepsin administration through 28 days after the last administration (at day 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4 received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants	OG000

Primary

Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohorts 1-3

Baseline is defined as the average of the pre-entry and entry values. Hour 24/48 is defined as the average of values at 24 and 48 hours after the single administration of Romidepsin or placebo (at study entry).

Change was calculated as the value at hour 24/48 minus the value at baseline.

Cohorts 1-3 participants

Posted

Median

Inter-Quartile Range

log10 copies/mL

Pre-entry, entry, 24 and 48 hours after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants

Primary

Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohort 4

Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) minus the value at baseline.

Cohort 4 participants

Posted

Median

Inter-Quartile Range

log10 copies/mL

Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Primary

Change From Baseline in Cell-associated HIV-1 RNA Levels in Resting CD4 T-cells in Cohorts 1-3

Baseline is defined as the pre-entry value. Change was calculated as the value at 24 hours after administration of Romidepsin or placebo (at entry) minus the value at baseline.

Cohorts 1-3 participants

Posted

Median

Inter-Quartile Range

log10 (copies/10^6 resting CD4 cells)

Pre-entry and 24 hours after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants	OG000

Primary

Change From Baseline in Cell-associated HIV-1 RNA Levels in PBMCs in Cohort 4

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

log10 (copies/10^6 PBMCs)

Pre-entry, entry and 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Secondary

Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohorts 1-3

Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 6 hours, 12 hours, 7 days, 14 days and 28 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

log10 copies/mL

Pre-entry, entry, 6 hours, 12 hours, 7 days, 14 days and 28 days after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants

Secondary

Change From Baseline in Plasma HIV-1 RNA Levels as Detected by Single Copy Assay in Cohort 4

Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 72 hours after the second administration of Romidepsin or placebo (at day 14) minus the value at baseline.

Cohort 4 participants

Posted

Median

Inter-Quartile Range

log10 copies/mL

Pre-entry, entry and 72 hours after the second administration of Romidepsin or placebo (at day 14)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Cell-associated HIV-1 RNA Levels in Resting CD4 T Cells in Cohorts 1-3

Baseline is defined as the pre-entry value. Change was calculated as the value at 14 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

log10 copies/mL

Pre-entry and 14 days after the administration of RMD or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Cell-associated HIV-1 RNA Levels in PBMCs in Cohort 4

Baseline is defined as the pre-entry value. Change was calculated as the value at 72 hours after the second administration of Romidepsin or placebo (at day 14) minus the value at baseline.

Cohort 4 participants

Posted

Median

Inter-Quartile Range

log10 copies/mL

Pre-entry and 72 hours after the second administration of Romidepsin or placebo (at day 14)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Histone Acetylation (Median FITC Ac-Histone) in CD3+ Cells in Cohorts 1-3

Baseline is defined as the value at Hour 0, right before the single administration of Romidepsin or placebo.

Change was calculated as the value at 24 hours after administration of Romidepsin or placebo (at entry) minus the value at baseline.

Median Fluorescent Intensity (MFI) data describes a shift in the expression of a fluorescently labeled marker on a population of cells. The reported MFI is an arbitrary value dependent on the voltage applied to the corresponding flow cytometer detector.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

arbitrary units

Hour 0 and 24 hours after the single administration of RMD or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts

Secondary

Change From Baseline in Histone Acetylation in (Median FITC Ac-histone) in CD3+ Cells in Cohort 4

Baseline is defined as the value right before the first administration of Romidepsin or placebo (at entry).

Change was calculated as the value at 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration minus the value at baseline.

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

arbitrary units

Entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42), and 72 hours after the second administration (at day 14)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Secondary

Change From Baseline in Total HIV-1 DNA in Resting or Total CD4 T Cells in Cohorts 1-3

Baseline is defined as the pre-entry value. Change was calculated as the value at 24 hours and 14 days after administration of Romidepsin or placebo (at entry) minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

log10 (copies/10^6 resting CD4 cells)

Pre-entry, 24 hours and 14 days after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Total HIV-1 DNA in PBMCs in Cohort 4

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

log10 (copies/10^6 PBMCs)

Pre-entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Secondary

PK Parameters for Romidepsin and Co-administered Antiretroviral Drugs (Efavirenz, Dolutegravir, or Raltegravir) in Cohorts 1-3

Hour 0 is right before the single administration of Romidepsin or placebo (at entry).

Hour 4 is at the completion of Romidepsin or placebo administration. Hours 6, 12 and 24 are 2, 8 and 20 hours after the completion of Romidepsin or placebo administration.

PK concentration (ng/mL) for Romidepsin at hours 0, 4, 6, 12 and 24. PK concentration (ng/mL) for co-administered antiretroviral drugs (Efavirenz [EFV], Dolutegravir [DTG], or Raltegravir [RAL]) at hours 0 and 24.

For Romidepsin PK parameters: Cohorts 1-3 participants who received Romidepsin. For co-administered antiretroviral drugs PK parameters: Cohorts 1-3 participants.

Posted

Median

Inter-Quartile Range

ng/mL

At hours 0, 4, 6, 12 and 24

ID	Title	Description
OG000	Cohort 1-Arm 1A (Romidepsin)	Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohort 2-Arm 2A (Romidepsin)	Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG002	Cohort 3-Arm 3A (Romidepsin)

Secondary

PK Parameters for Romidepsin and Co-administered Antiretroviral Drugs (Dolutegravir or Raltegravi) in Cohort 4

PK concentration (ng/mL) for Romidepsin pre and post the third and fourth administrations of Romidepsin or placebo.

PK concentration (ng/mL) for co-administered antiretroviral drugs (Dolutegravir [DTG], or Raltegravir [RAL]) 24 hours after the third and fourth administrations of Romidepsin or placebo.

For Romidepsin PK parameters: Cohort 4 participants who received the third and fourth Romidepsin infusion.

For co-administered antiretroviral drugs PK parameters: Cohort 4 participants who received the third and fourth Romidepsin or placebo infusion.

Posted

Median

Inter-Quartile Range

ng/mL

Pre, post and 24 hours after the third and fourth administrations of Romidepsin or placebo (at days 28 and 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Secondary

HIV-1 RNA Levels in Cohorts 1-3

HIV-1 RNA levels at 7 days after the single administration of Romidepsin or placebo (at entry)

Cohorts 1-3 participants

Posted

Count of Participants

Participants

7 days after the administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohort 1-Arm 1A (Romidepsin)	Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohort 2-Arm 2A (Romidepsin)	Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG002	Cohort 3-Arm 3A (Romidepsin)	Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG003	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3, received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Secondary

HIV-1 RNA Levels in Cohort 4

HIV-1 RNA levels at 7 days after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)

Cohort 4 participants with available data

Posted

Count of Participants

Participants

7 days after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Reported Grade 2-4 AEs in Cohorts 1-3

Number of participants with reported grade 2-4 adverse events including signs/symptoms, lab toxicities, and clinical events that are at least possibly related to study treatment. The DAIDS AE Grading Table (Version 1.0) was used.

Cohorts 1-3 participants

Posted

Count of Participants

Participants

Measured from study entry to off study

ID	Title	Description
OG000	Cohort 1-Arm 1A (Romidepsin)	Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohort 2-Arm 2A (Romidepsin)	Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG002	Cohort 3-Arm 3A (Romidepsin)	Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG003	Cohorts 1-3 (Placebo for Romidepsin)

Secondary

Number of Participants With Reported Grade 2-4 AEs in Cohort 4

Cohort 4 participants

Posted

Count of Participants

Participants

Measured from study entry to off study

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4+ and CD8+ T Cell Percent in Cohorts 1-3

Change in CD4+ and CD8+T cell percent from baseline to after the single administration of Romidepsin or placebo

Cohorts 1-3 participants did not have CD4+ and CD8+ T cell percent collected

Posted

Measured through participant's last study visit

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in CD4+ T Cell Percent in Cohort 4

Baseline is defined as the average of the pre-entry and entry values. Change was calculated as the value at 24 hours post each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 2, 5, 10 and 18 weeks post the fourth administration minus the value at baseline

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD4 cells

Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42), and 2, 5, 10 and 18 weeks after the fourth administration (at day 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Secondary

Change From Baseline in CD8+ T Cell Percent in Cohort 4

Change in CD8+ T cell percent from baseline to after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42)

Cohort 4 participants did not have CD8+ T cell percent collected

Posted

Measured through 28 days after the single administration of RMD or placebo (at entry, and days 14, 28 and 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD4+ T-cells) in Cohorts 1-3

Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).

Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD4 cells

Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants

Secondary

Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD8+ T-cells) in Cohorts 1-3

Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).

Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD8 cells

Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants

Secondary

Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD4+ T-cells) in Cohorts 1-3

Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).

Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD4 cells

Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants

Secondary

Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD8+ T-cells) in Cohorts 1-3

Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).

Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD8 cells

Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants

Secondary

Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD4+ T-cells) in Cohort 4

Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at entry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD4 cells

Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Secondary

Change From Baseline in Cellular Markers of Immune Activation (CD38/HLA-DR Expression on CD8+ T-cells) in Cohort 4

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD8 cells

Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Secondary

Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD4+ T-cells) in Cohort 4

Baseline is defined as the average of the two pre-entry values. Change was calculated as the value at 24 hours post first and fourth administration of Romidepsin or placebo (at etnry and day 42) and 10 weeks post the fourth administration (at day 42) minus the value at baseline.

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD4 cells

Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at etnry and day 42), and 10 weeks after the fourth administration (at day 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Secondary

Change From Baseline in Cellular Markers of Immune Activation (CD69/CD25 Expression on CD8+ T-cells) in Cohort 4

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD8 cells

Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at etnry and day 42), and 10 weeks after the fourth administration (at day 42

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Secondary

Change From Baseline in Percentage of CD4+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohorts 1-3

Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).

Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD4 cells

Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants

Secondary

Change From Baseline in Percentage of CD8+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohorts 1-3

Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).

Change was calculated as the value at 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD8 cells

Hour 0 and 48 hours, 7 days and 28 days after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants

Secondary

Change From Baseline in Percentage of CD4+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohort 4

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD4 cells

Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Secondary

Change From Baseline in Percentage of CD8+ T-cells Expressing Annexin V and/or 7 Amino-actinomycin D (7-AAD) in Cohort 4

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD8 cells

Pre-entry, 24 hours after the first and fourth administration of Romidepsin or placebo (at entry and day 42), and 10 weeks after the fourth administration (at day 42)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Secondary

Change From Baseline in PTEF-b Phosphorylation (pNFKB+% and pS175%) in CD4+ T-cells in Cohorts 1-3

Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).

Change was calculated as the value at 24 hours after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD4 cells

Hour 0 and 24 hours after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants

Secondary

Change From Baseline in PTEF-b Phosphorylation (pNFKB+% and pS175%) in CD8+ T-cells in Cohorts 1-3

Baseline is defined as the value at hour 0, where hour 0 is right before the single administration of Romidepsin or placebo (at entry).

Change was calculated as the value at 24 hours after the single administration of Romidepsin or placebo (at entry) minus the value at baseline.

Cohorts 1-3 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD8 cells

Hour 0 and 24 hours after the single administration of Romidepsin or placebo (at entry)

ID	Title	Description
OG000	Cohorts 1-3 (Romidepsin)	Participants in Cohorts 1-3 who received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
OG001	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.

Units	Counts
Participants

Secondary

Change From Baseline in PTEF-b Phosphorylation (pNFKB+%) in CD4+ T-cells in Cohort 4

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD4 cells

Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Secondary

Change From Baseline in PTEF-b Phosphorylation (pS175+%) in CD4+ T-cells in Cohort 4

Cohort 4 participants with available data

Posted

Median

Inter-Quartile Range

percentage of CD4 cells

Pre-entry, entry, 24 hours after each administration of Romidepsin or placebo (at entry, and days 14, 28 and 42) and 72 hours after the second administration (at day 14)

ID	Title	Description
OG000	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
OG001	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG0030 affected7 at risk EG0040 affected13 at risk EG0051 affected3 at risk
Bradycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Deafness	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Eye discharge	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Vision blurred	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Fatigue	General disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Malaise	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Pyrexia	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Abscess bacterial	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Bacterial vaginosis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Influenza	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Onychomycosis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Viral tonsillitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Infusion related reaction	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Blood creatinine increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 affected12 at risk EG0010 affected12 at risk EG0021 affected12 at risk EG003
Blood glucose increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Blood pressure increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0021 affected12 at risk EG003
Creatinine renal clearance decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Electrocardiogram PR prolongation	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Electrocardiogram QT interval normal	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 21.1	Systematic Assessment	EG0003 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Haemoglobin abnormal	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Haemoglobin decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Neutrophil count decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Joint noise	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0012 affected12 at risk EG0020 affected12 at risk EG003
Presyncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Upper-airway cough syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Nail discolouration	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0011 affected12 at risk EG0020 affected12 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Abdominoplasty	Surgical and medical procedures	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003
Hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected12 at risk EG0010 affected12 at risk EG0020 affected12 at risk EG003

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
C087123	romidepsin
D000077330	Saline Solution
D012965	Sodium Chloride

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds

ID	Title	Description
BG000	Cohort 1-Arm 1A (Romidepsin)	Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.
BG001	Cohort 2-Arm 2A (Romidepsin)	Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
BG002	Cohort 3-Arm 3A (Romidepsin)	Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
BG003	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.
BG004	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
BG005	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.
BG006	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort 1-Arm 1A (Romidepsin)	Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit.	12	0	12	8	12
EG001	Cohort 2-Arm 2A (Romidepsin)	Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.	12	0	12	6	12
EG002	Cohort 3-Arm 3A (Romidepsin)	Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.	12	0	12	1	12
EG003	Cohorts 1-3 (Placebo for Romidepsin)	Participants in Cohorts 1-3 who received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0 study visit.	7	0	7	3	7
EG004	Cohort 4-Arm 4A (Romidepsin)	Participants in Cohort 4, Arm 4A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.	13	0	13	9	13
EG005	Cohort 4-Arm 4B (Placebo for Romidepsin)	Participants in Cohort 4, Arm 4B received 0.9% sodium chloride for injection IV over 4 hours (beginning at Hour 0) at the Day 0, 14, 28, and 42 study visits.	3	1	3	2	3