Evaluating the Safety and Efficacy of Romidepsin in Combination With Antiretroviral Therapy in HIV-Infected Adults With Suppressed Viral Load
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ClinicalTrials.gov Identifier: NCT01933594 |
Recruitment Status :
Completed
First Posted : September 2, 2013
Results First Posted : May 23, 2019
Last Update Posted : May 23, 2019
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Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
HIV Infections |
Interventions |
Drug: Romidepsin Drug: Placebo for Romidepsin |
Enrollment | 59 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Cohort 1-Arm 1A (Romidepsin) | Cohort 2-Arm 2A (Romidepsin) | Cohort 3-Arm 3A (Romidepsin) | Cohorts 1-3 (Placebo for Romidepsin) | Cohort 4-Arm 4A (Romidepsin) | Cohort 4-Arm 4B (Placebo for Romidepsin) |
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Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit. | Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. | Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. | 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. | 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. | 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. |
Period Title: Overall Study | ||||||
Started | 12 | 12 | 12 | 7 | 13 | 3 |
Completed | 11 | 12 | 12 | 7 | 11 | 3 |
Not Completed | 1 | 0 | 0 | 0 | 2 | 0 |
Reason Not Completed | ||||||
Lost to Follow-up | 1 | 0 | 0 | 0 | 1 | 0 |
Ineligible for subsequent study step | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Cohort 1-Arm 1A (Romidepsin) | Cohort 2-Arm 2A (Romidepsin) | Cohort 3-Arm 3A (Romidepsin) | Cohorts 1-3 (Placebo for Romidepsin) | Cohort 4-Arm 4A (Romidepsin) | Cohort 4-Arm 4B (Placebo for Romidepsin) | Total | |
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Participants in Cohort 1, Arm 1A received Romidepsin intravenously (IV) over 4 hours (beginning at Hour 0) at the Day 0 study visit. | Participants in Cohort 2, Arm 2A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. | Participants in Cohort 3, Arm 3A received Romidepsin IV over 4 hours (beginning at Hour 0) at the Day 0 study visit. | 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. | 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. | 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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 12 | 12 | 12 | 7 | 13 | 3 | 59 | |
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All enrolled participants. The placebo arms of Cohorts 1-3 were combined for the Baseline Characteristics.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||||||
Number Analyzed | 12 participants | 12 participants | 12 participants | 7 participants | 13 participants | 3 participants | 59 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
12 100.0%
|
12 100.0%
|
11 91.7%
|
6 85.7%
|
11 84.6%
|
3 100.0%
|
55 93.2%
|
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>=65 years |
0 0.0%
|
0 0.0%
|
1 8.3%
|
1 14.3%
|
2 15.4%
|
0 0.0%
|
4 6.8%
|
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Age, Continuous
Median (Inter-Quartile Range) Unit of measure: Years |
||||||||
Number Analyzed | 12 participants | 12 participants | 12 participants | 7 participants | 13 participants | 3 participants | 59 participants | |
50
(29 to 54)
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52
(44 to 54)
|
51
(37 to 58)
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51
(44 to 56)
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56
(48 to 61)
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45
(34 to 53)
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52
(41 to 57)
|
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 12 participants | 12 participants | 12 participants | 7 participants | 13 participants | 3 participants | 59 participants | |
Female |
1 8.3%
|
1 8.3%
|
1 8.3%
|
0 0.0%
|
4 30.8%
|
1 33.3%
|
8 13.6%
|
|
Male |
11 91.7%
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11 91.7%
|
11 91.7%
|
7 100.0%
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9 69.2%
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2 66.7%
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51 86.4%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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White non-Hispanic | Number Analyzed | 12 participants | 12 participants | 12 participants | 7 participants | 13 participants | 3 participants | 59 participants |
8 66.7%
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8 66.7%
|
6 50.0%
|
5 71.4%
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6 46.2%
|
2 66.7%
|
35 59.3%
|
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Black non-Hispanic | Number Analyzed | 12 participants | 12 participants | 12 participants | 7 participants | 13 participants | 3 participants | 59 participants |
4 33.3%
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3 25.0%
|
5 41.7%
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2 28.6%
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6 46.2%
|
1 33.3%
|
21 35.6%
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Hispanic (regardless of race) | Number Analyzed | 12 participants | 12 participants | 12 participants | 7 participants | 13 participants | 3 participants | 59 participants |
0 0.0%
|
0 0.0%
|
1 8.3%
|
0 0.0%
|
1 7.7%
|
0 0.0%
|
2 3.4%
|
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Asian, Pacific Islander | Number Analyzed | 12 participants | 12 participants | 12 participants | 7 participants | 13 participants | 3 participants | 59 participants |
0 0.0%
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1 8.3%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
1 1.7%
|
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 12 participants | 12 participants | 12 participants | 7 participants | 13 participants | 3 participants | 59 participants |
12 100.0%
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12 100.0%
|
12 100.0%
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7 100.0%
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13 100.0%
|
3 100.0%
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59 100.0%
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Baseline SCA in Cohorts 1-3
[1] [2] Median (Inter-Quartile Range) Unit of measure: Log10 copies/mL |
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Number Analyzed | 12 participants | 12 participants | 12 participants | 7 participants | 0 participants | 0 participants | 43 participants | |
0.08
(-0.13 to 0.32)
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-0.2
(-0.49 to 0.02)
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0.22
(-0.6 to 0.57)
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0.38
(0.22 to 0.51)
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NA [3]
(NA to NA)
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[1]
Measure Description: Baseline HIV-1 RNA levels as detected by single copy assay (SCA) was calculated as the average of the pre-entry and entry SCA measurements for Cohorts 1-3
[2]
Measure Analysis Population Description: Cohorts 1-3 were analyzed separately from Cohort 4
[3]
Cohorts 1-3 and Cohort 4 were conducted as separate studies under the same study protocol. As such, all analyses were conducted separately for Cohorts 1-3 and Cohort 4.
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Baseline SCA in Cohort 4
[1] [2] Median (Inter-Quartile Range) Unit of measure: Log10 copies/mL |
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Number Analyzed | 0 participants | 0 participants | 0 participants | 0 participants | 13 participants | 3 participants | 16 participants | |
-0.2
(-0.7 to 0.39)
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-0.25
(-0.25 to 0.31)
|
NA [3]
(NA to NA)
|
||||||
[1]
Measure Description: Baseline HIV-1 RNA levels as detected by single copy assay (SCA) was calculated as the average of the pre-entry and entry SCA measurements for Cohort 4
[2]
Measure Analysis Population Description: Cohorts 1-3 were analyzed separately from Cohort 4
[3]
Cohorts 1-3 and Cohort 4 were conducted as separate studies under the same study protocol. As such, all analyses were conducted separately for Cohorts 1-3 and Cohort 4.
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Baseline CA RNA in Cohorts 1-3
[1] [2] Median (Inter-Quartile Range) Unit of measure: Log10 copies/mL |
||||||||
Number Analyzed | 12 participants | 12 participants | 12 participants | 7 participants | 0 participants | 0 participants | 43 participants | |
1.9
(1.7 to 2.6)
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2.6
(2.3 to 3)
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2.3
(2.0 to 2.7)
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2.8
(2.4 to 3)
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NA [3]
(NA to NA)
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[1]
Measure Description: Baseline cell-associated HIV-1 RNA levels (CA-RNA) (log10 copies/mL) were measured in resting CD4 T-cells for Cohorts 1-3. Baseline CA-RNA is the pre-entry measurement for Cohorts 1-3.
[2]
Measure Analysis Population Description: Cohorts 1-3 were analyzed separately from Cohort 4
[3]
Cohorts 1-3 and Cohort 4 were conducted as separate studies under the same study protocol. As such, all analyses were conducted separately for Cohorts 1-3 and Cohort 4.
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Baseline CA RNA in Cohort 4
[1] [2] Median (Inter-Quartile Range) Unit of measure: Log10 copies/mL |
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Number Analyzed | 0 participants | 0 participants | 0 participants | 0 participants | 13 participants | 3 participants | 16 participants | |
1.19
(0.9 to 1.64)
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1.61
(1.49 to 2.44)
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NA [3]
(NA to NA)
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||||||
[1]
Measure Description: Baseline cell-associated HIV-1 RNA levels (CA-RNA) (log10 copies/mL) were measured in PBMCs for Cohort 4. Baseline CA-RNA was calculated as the average of the pre-entry and entry CA-RNA measurement for Cohort 4.
[2]
Measure Analysis Population Description: Cohorts 1-3 were analyzed separately from Cohort 4
[3]
Cohorts 1-3 and Cohort 4 were conducted as separate studies under the same study protocol. As such, all analyses were conducted separately for Cohorts 1-3 and Cohort 4.
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Outcome Measures
Adverse Events