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NCT01193842 · OUTCOME

Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)

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
copies per milliliter
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: Eligible participants who returned for follow-up with evaluable data.

Groups in this outcome

Phase I: VR-DA-EPOCH, Dose Level 1

Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)

Phase I: VR-DA-EPOCH, Dose Level 2

Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)

Phase I: VR-CHOP, Dose Level 1

Phase I, Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase I: VR-DA-EPOCH, Dose Level 16
Phase I: VR-DA-EPOCH, Dose Level 26
Phase I: VR-CHOP, Dose Level 11

Reported measurements

End of cycle 2

Analysis denominator · Participants

GroupSource count
Phase I: VR-DA-EPOCH, Dose Level 16
Phase I: VR-DA-EPOCH, Dose Level 26
Phase I: VR-CHOP, Dose Level 11
Values in copies per milliliter · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 1-14518Not reported-543520Not reported
Phase I: VR-DA-EPOCH, Dose Level 2-12.5Not reported-660Not reported
Phase I: VR-CHOP, Dose Level 128Not reported2828Not reported
Treatment discontinuation

Analysis denominator · Participants

GroupSource count
Phase I: VR-DA-EPOCH, Dose Level 16
Phase I: VR-DA-EPOCH, Dose Level 25
Phase I: VR-CHOP, Dose Level 11
Values in copies per milliliter · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 1-4517Not reported-551160Not reported
Phase I: VR-DA-EPOCH, Dose Level 20Not reported-8849Not reported
Phase I: VR-CHOP, Dose Level 10Not reported00Not reported
6-month follow-up

Analysis denominator · Participants

GroupSource count
Phase I: VR-DA-EPOCH, Dose Level 13
Phase I: VR-DA-EPOCH, Dose Level 25
Phase I: VR-CHOP, Dose Level 11
Values in copies per milliliter · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 1-55116Not reported-2829770Not reported
Phase I: VR-DA-EPOCH, Dose Level 20Not reported-880Not reported
Phase I: VR-CHOP, Dose Level 10Not reported00Not reported
12-month follow-up

Analysis denominator · Participants

GroupSource count
Phase I: VR-DA-EPOCH, Dose Level 11
Phase I: VR-DA-EPOCH, Dose Level 25
Phase I: VR-CHOP, Dose Level 11
Values in copies per milliliter · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Phase I: VR-DA-EPOCH, Dose Level 10Not reported00Not reported
Phase I: VR-DA-EPOCH, Dose Level 20Not reported-880Not reported
Phase I: VR-CHOP, Dose Level 10Not reported00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -54352
        upper Limit
        0
        value
        -14518
      2. group Id
        OG001
        lower Limit
        -66
        upper Limit
        0
        value
        -12.5
      3. group Id
        OG002
        lower Limit
        28
        upper Limit
        28
        value
        28
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    End of cycle 2
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -55116
        upper Limit
        0
        value
        -4517
      2. group Id
        OG001
        lower Limit
        -88
        upper Limit
        49
        value
        0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Treatment discontinuation
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        -282977
        upper Limit
        0
        value
        -55116
      2. group Id
        OG001
        lower Limit
        -88
        upper Limit
        0
        value
        0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    6-month follow-up
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        0
        value
        0
      2. group Id
        OG001
        lower Limit
        -88
        upper Limit
        0
        value
        0
      3. group Id
        OG002
        lower Limit
        0
        upper Limit
        0
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    12-month follow-up
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      1
    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
  1. description
    Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1)
    id
    OG000
    title
    Phase I: VR-DA-EPOCH, Dose Level 1
  2. description
    Phase I, Arm A (VR-DA-EPOCH) with Vorinostat at 400 mg once a day on days 1-5 of a cycle (Phase I Dose Level 2)
    id
    OG001
    title
    Phase I: VR-DA-EPOCH, Dose Level 2
  3. description
    Phase I, Arm C (VR-CHOP) with Vorinostat at 300 mg once a day on days 1-5 of a cycle (Phase I Dose Level 1 for low risk participants). This arm was discontinued due to low accrual.
    id
    OG002
    title
    Phase I: VR-CHOP, Dose Level 1
param Type
MEDIAN
population Description
Eligible participants who returned for follow-up with evaluable data.
reporting Status
POSTED
time Frame
Baseline up to 12 months
title
Change in Plasma Associated Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) (Phase I)
type
SECONDARY
unit Of Measure
copies per milliliter

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice