NCT01193842 · OUTCOME
Changes in Human Immunodeficiency Virus (HIV) Viral Load
Vorinostat and Combination Chemotherapy With Rituximab in Treating Patients With HIV-Related Diffuse Large B-Cell Non-Hodgkin Lymphoma or Other Aggressive B-Cell Lymphomas · Source last updated 2023-11-21
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- median change in copies per mL
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Baseline up to 12 months
What was measured
Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.
Analysis population: Phase II participants who returned for follow-up with evaluable data.
Groups in this outcome
Phase II: VR-DA-EPOCH
Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
Phase II: DA-R-EPOCH
Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase II: VR-DA-EPOCH | 42 |
|---|
| Phase II: DA-R-EPOCH | 41 |
|---|
Reported measurements
End of Cycle 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase II: VR-DA-EPOCH | 42 |
|---|
| Phase II: DA-R-EPOCH | 41 |
|---|
Values in median change in copies per mL · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase II: VR-DA-EPOCH | -20 | Not reported | -22607 | 0 | Not reported |
|---|
| Phase II: DA-R-EPOCH | -25 | Not reported | -3308 | 0 | Not reported |
|---|
At treatment discontinuation
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase II: VR-DA-EPOCH | 42 |
|---|
| Phase II: DA-R-EPOCH | 40 |
|---|
Values in median change in copies per mL · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase II: VR-DA-EPOCH | -87 | Not reported | -28176 | 0 | Not reported |
|---|
| Phase II: DA-R-EPOCH | -22.5 | Not reported | -1962 | 4.5 | Not reported |
|---|
6-month follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase II: VR-DA-EPOCH | 42 |
|---|
| Phase II: DA-R-EPOCH | 26 |
|---|
Values in median change in copies per mL · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase II: VR-DA-EPOCH | -20 | Not reported | -24703 | 0 | Not reported |
|---|
| Phase II: DA-R-EPOCH | -18 | Not reported | -3258 | 0 | Not reported |
|---|
12-month follow-up
Analysis denominator · Participants
| Group | Source count |
|---|
| Phase II: VR-DA-EPOCH | 42 |
|---|
| Phase II: DA-R-EPOCH | 23 |
|---|
Values in median change in copies per mL · Interval/dispersion: Inter-Quartile Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Phase II: VR-DA-EPOCH | 0 | Not reported | -22656 | 20 | Not reported |
|---|
| Phase II: DA-R-EPOCH | -20 | Not reported | -3361 | 0 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- -22607
- upper Limit
- 0
- value
- -20
- group Id
- OG001
- lower Limit
- -3308
- upper Limit
- 0
- value
- -25
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 41
- units
- Participants
- title
- End of Cycle 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- -28176
- upper Limit
- 0
- value
- -87
- group Id
- OG001
- lower Limit
- -1962
- upper Limit
- 4.5
- value
- -22.5
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 40
- units
- Participants
- title
- At treatment discontinuation
- categories
- measurements
- group Id
- OG000
- lower Limit
- -24703
- upper Limit
- 0
- value
- -20
- group Id
- OG001
- lower Limit
- -3258
- upper Limit
- 0
- value
- -18
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 26
- units
- Participants
- title
- 6-month follow-up
- categories
- measurements
- group Id
- OG000
- lower Limit
- -22656
- upper Limit
- 20
- value
- 0
- group Id
- OG001
- lower Limit
- -3361
- upper Limit
- 0
- value
- -20
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 23
- units
- Participants
- title
- 12-month follow-up
- denoms
- counts
- group Id
- OG000
- value
- 42
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- Differences from baseline (specified follow-up assessment minus baseline) in HIV viral load. Undetectable viral load results were treated as 0 values.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Arm A (VR-DA-EPOCH) at the recommended phase II dose of Vorinostat (300 mg once a day for days 1-5 of a cycle)
- id
- OG000
- title
- Phase II: VR-DA-EPOCH
- description
- Arm B (DA-R-EPOCH), which is the same treatment as Arm A, but without Vorinostat
- id
- OG001
- title
- Phase II: DA-R-EPOCH
- param Type
- MEDIAN
- population Description
- Phase II participants who returned for follow-up with evaluable data.
- reporting Status
- POSTED
- time Frame
- Baseline up to 12 months
- title
- Changes in Human Immunodeficiency Virus (HIV) Viral Load
- type
- SECONDARY
- unit Of Measure
- median change in copies per mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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