ClinicalTrials.gov
ClinicalTrials.gov Menu

Antiretroviral Therapy (ART) Alone or With Delayed Chemo Versus ART With Immediate Chemo for Limited AIDS-related Kaposi's Sarcoma (REACT-KS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01352117
Recruitment Status : Active, not recruiting
First Posted : May 11, 2011
Results First Posted : July 31, 2017
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV-1 Infection
Kaposi's Sarcoma
Interventions Drug: efavirenz/emtricitabine/tenofovir disoproxil fumarate
Drug: etoposide
Enrollment 192
Recruitment Details Participants were recruited from November 2011 to February 2016 at 10 sites in Africa and South America.
Pre-assignment Details  
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Period Title: Overall Study
Started 96 96
Entered Step 2 to Initiate Delayed ET 32 0 [1]
Study Week 48 Data Potential [2] 80 83
Study Week 96 Data Potential [3] 58 61
Completed [4] 28 0
Not Completed 68 96
Reason Not Completed
On study             49             80
Death             13             12
Withdrawal by Subject             1             0
Lost to Follow-up             2             4
Non-adherent to study requirements             1             0
Did not initiate study treatment             1             0
Ineligible (no KS diagnosis)             1             0
[1]
Only Arm A participants could enter Step 2 to receive delayed ET.
[2]
Enrolled >=45 weeks prior to the date when DSMB's recommendation to close the study became public.
[3]
Enrolled >=93 weeks prior to the date when DSMB's recommendation to close the study became public.
[4]
Completed study, including the long-term safety follow-up in Step 3.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET Total
Hide Arm/Group Description Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks. Total of all reporting groups
Overall Number of Baseline Participants 94 96 190
Hide Baseline Analysis Population Description
All eligible participants who initiated study treatment.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 94 participants 96 participants 190 participants
34
(28 to 41)
35
(30 to 41)
34
(29 to 41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 96 participants 190 participants
Female
66
  70.2%
69
  71.9%
135
  71.1%
Male
28
  29.8%
27
  28.1%
55
  28.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 96 participants 190 participants
Hispanic or Latino
8
   8.5%
8
   8.3%
16
   8.4%
Not Hispanic or Latino
83
  88.3%
86
  89.6%
169
  88.9%
Unknown or Not Reported
3
   3.2%
2
   2.1%
5
   2.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 96 participants 190 participants
Malawi
30
  31.9%
32
  33.3%
62
  32.6%
Brazil
4
   4.3%
5
   5.2%
9
   4.7%
Uganda
28
  29.8%
30
  31.3%
58
  30.5%
Zimbabwe
9
   9.6%
7
   7.3%
16
   8.4%
South Africa
6
   6.4%
6
   6.3%
12
   6.3%
Kenya
15
  16.0%
13
  13.5%
28
  14.7%
Peru
2
   2.1%
3
   3.1%
5
   2.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 96 participants 190 participants
Asian
0
   0.0%
1
   1.0%
1
   0.5%
Black or African American
89
  94.7%
88
  91.7%
177
  93.2%
White
2
   2.1%
5
   5.2%
7
   3.7%
Other
3
   3.2%
2
   2.1%
5
   2.6%
HIV-1 RNA  
Median (Inter-Quartile Range)
Unit of measure:  Log10 copies/mL
Number Analyzed 94 participants 96 participants 190 participants
5.11
(4.48 to 5.62)
5.10
(4.59 to 5.47)
5.11
(4.53 to 5.50)
CD4 cell count, continuous  
Median (Inter-Quartile Range)
Unit of measure:  Cells/mm^3
Number Analyzed 94 participants 96 participants 190 participants
190
(88 to 325)
165
(63 to 327)
184
(78 to 325)
CD4 cell count, categorized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 96 participants 190 participants
<200 cells/mm^3
50
  53.2%
53
  55.2%
103
  54.2%
>=200 cells/mm^3
44
  46.8%
43
  44.8%
87
  45.8%
Karnofsky score   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 96 participants 190 participants
60
1
   1.1%
0
   0.0%
1
   0.5%
70
8
   8.5%
5
   5.2%
13
   6.8%
80
26
  27.7%
26
  27.1%
52
  27.4%
90
54
  57.4%
60
  62.5%
114
  60.0%
100
5
   5.3%
5
   5.2%
10
   5.3%
[1]
Measure Description: Karnofsky performance scale is from 0 (dead) to 100 (normal; no complaint; no evidence of disease) by 10.
KS stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 96 participants 190 participants
KS tumor Stage T0
35
  37.2%
40
  41.7%
75
  39.5%
KS tumor Stage T1
59
  62.8%
56
  58.3%
115
  60.5%
[1]
Measure Description: KS tumor stage was determined by the ACTG criteria (refer to Protocol Section, References) where Stage T0 (good risk) is defined as KS confined to skin and/or lymph nodes and/or minimal oral KS and Stage T1 (poor risk) as presence of tumor-associated edema and/or presence of oral KS beyond flat lesions confined to the palate and/or presence of asymptomatic gastrointestinal KS.
ART experience  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 96 participants 190 participants
ART-experienced
0
   0.0%
1
   1.0%
1
   0.5%
ART-naive
94
 100.0%
95
  99.0%
189
  99.5%
1.Primary Outcome
Title Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry
Hide Description KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS progression (PD), initiation of an alternate KS treatment, or no follow-up at Week 48 including death and missed visit), E2 (Stable: in follow-up at Week 48 with no KS PD nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 48, with KS partial or complete response (PR or CR) and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PR, stable, PR, CR) compared to study entry was evaluated at Week 48 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and dea
Time Frame Entry through Week 48.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the Data and Safety Monitoring Board's [DSMB] recommendation to close the study became public).
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 80 83
Measure Type: Count of Participants
Unit of Measure: Participants
E1 (Failure)
43
  53.8%
47
  56.6%
E2 (Stable)
13
  16.3%
9
  10.8%
E3 (Response)
24
  30.0%
27
  32.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: ART Alone or With Delayed ET, Arm B: ART With Immediate ET
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.911
Comments The critical value for the final analysis was adjusted for the three interim analyses conducted for the Data and Safety Monitoring Board (DSMB) review using the Haybittle-Peto guidelines, at the p-value cutoff of 0.0487.
Method Wilcoxon (Mann-Whitney)
Comments Stratified Wilcoxon-Mann-Whitney test (asymptotic method) known as van Elteren test, stratification by screening CD4 (<200 vs. >=200 cells/mm^3).
2.Secondary Outcome
Title KS Progressive Disease at Week 48 Compared to Study Entry
Hide Description KS progressive disease (PD) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Time Frame Entry and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 58 43
Measure Type: Count of Participants
Unit of Measure: Participants
KS PD at Week 48
21
  36.2%
7
  16.3%
No KS PD at Week 48
37
  63.8%
36
  83.7%
3.Secondary Outcome
Title KS Partial Response at Week 48 Compared to Study Entry
Hide Description KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Time Frame Entry and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 58 43
Measure Type: Count of Participants
Unit of Measure: Participants
KS PR at Week 48
21
  36.2%
23
  53.5%
No KS PR at Week 48
37
  63.8%
20
  46.5%
4.Secondary Outcome
Title KS Complete Response at Week 48 Compared to Study Entry
Hide Description KS complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Time Frame Entry and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 58 43
Measure Type: Count of Participants
Unit of Measure: Participants
KS CR at Week 48
3
   5.2%
4
   9.3%
No KS CR at Week 48
55
  94.8%
39
  90.7%
5.Secondary Outcome
Title KS Partial or Complete Response at Week 48 Compared to Study Entry
Hide Description KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Time Frame Entry and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 48 KS exam performed and had not initiated alternate KS treatment before Week 48.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 58 43
Measure Type: Count of Participants
Unit of Measure: Participants
Week 48: KS PR or CR
24
  41.4%
27
  62.8%
Week 48: no KS PR or CR
34
  58.6%
16
  37.2%
6.Secondary Outcome
Title Premature Study Discontinuation by Week 48
Hide Description Premature study discontinuation by Week 48 due to any reason, including death.
Time Frame Entry through Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 48 data potential (i.e. participants enrolled at least 45 weeks prior to the date when the DSMB's recommendation to close the study became public).
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 80 83
Measure Type: Count of Participants
Unit of Measure: Participants
Premature study discontinuation by Week 48
13
  16.3%
11
  13.3%
No premature study discontinuation by Week 48
67
  83.8%
72
  86.7%
7.Secondary Outcome
Title Kaposi Sarcoma (KS) Status at Week 96 Compared to Study Entry
Hide Description KS status is a composite, categorical outcome, ordered from worst to best as E1 (Failure: KS PD, initiation of an alternate KS treatment, or no follow-up at Week 96 including death and missed visit), E2 (Stable: in follow-up at Week 96 with no KS progression nor response and without initiation of an alternate KS treatment) and E3 (Response: in follow-up at Week 96, with KS PR or CR and without initiation of an alternate KS treatment). Alternate KS treatment was defined as chemotherapy agent other than ET or other treatment triggered by worsening KS. KS outcome status (PD, stable, PR or CR) compared to study entry was evaluated at Week 96 based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Data on initiation of alternate KS treatment, loss to follow-up and deaths are from entry through Week 96.
Time Frame Entry through Week 96.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public).
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 58 61
Measure Type: Count of Participants
Unit of Measure: Participants
E1 (Failure)
33
  56.9%
33
  54.1%
E2 (Stable)
4
   6.9%
0
   0.0%
E3 (Response)
21
  36.2%
28
  45.9%
8.Secondary Outcome
Title KS Progressive Disease at Week 96 Compared to Study Entry
Hide Description KS progressive disease (PD) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Time Frame Entry and Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 35 30
Measure Type: Count of Participants
Unit of Measure: Participants
KS PD at Week 96
10
  28.6%
2
   6.7%
No KS PD at Week 96
25
  71.4%
28
  93.3%
9.Secondary Outcome
Title KS Partial Response at Week 96 Compared to Study Entry
Hide Description KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Time Frame Entry and Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 35 30
Measure Type: Count of Participants
Unit of Measure: Participants
KS PR at Week 96
19
  54.3%
24
  80.0%
No KS PR at Week 96
16
  45.7%
6
  20.0%
10.Secondary Outcome
Title KS Complete Response at Week 96 Compared to Study Entry
Hide Description KS complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Time Frame Entry and Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 35 30
Measure Type: Count of Participants
Unit of Measure: Participants
KS CR at Week 96
2
   5.7%
4
  13.3%
No KS CR at Week 96
33
  94.3%
26
  86.7%
11.Secondary Outcome
Title KS Partial or Complete Response at Week 96 Compared to Study Entry
Hide Description KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002).
Time Frame Entry and Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public) who had Week 96 KS exam performed and had not initiated alternate KS treatment before Week 96.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 35 30
Measure Type: Count of Participants
Unit of Measure: Participants
KS PR or CR at Week 96
21
  60.0%
28
  93.3%
No KS PR or CR at Week 96
14
  40.0%
2
   6.7%
12.Secondary Outcome
Title Premature Study Discontinuation by Week 96
Hide Description Premature study discontinuation by Week 96 due to any reason, including death.
Time Frame Entry through Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had Study Week 96 data potential (i.e. participants enrolled at least 93 weeks prior to the date when the DSMB's recommendation to close the study became public).
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 58 61
Measure Type: Count of Participants
Unit of Measure: Participants
Premature study discontinuation by Week 96
14
  24.1%
10
  16.4%
No premature study discontinuation by Week 96
44
  75.9%
51
  83.6%
13.Secondary Outcome
Title Cumulative Incidence of Initial KS Progressive Disease by Week 96
Hide Description KS progressive disease (PD) compared to study entry or best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.
Time Frame From entry through 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment.
Arm/Group Title Arm A: ART Alone Period (Step 1) Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative events per 100 participants
60.61
(48.98 to 70.38)
52.73
(40.17 to 63.82)
14.Secondary Outcome
Title Cumulative Incidence of Initial KS Partial or Complete Response by Week 96
Hide Description KS partial response (PR) or complete response (CR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of delayed KS treatment (alternate KS treatment or delayed ET in Arm A) as competing risks. Time at risk was censored at the end of Step 1 (Week 96 or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.
Time Frame From entry through 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment.
Arm/Group Title Arm A: ART Alone Period (Step 1) Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative events per 100 participants
39.89
(24.88 to 54.48)
64.08
(51.78 to 74.01)
15.Secondary Outcome
Title Cumulative Incidence of Initial KS Partial Response by Week 96
Hide Description KS partial response (PR) compared to study entry based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). This was initially part of the outcome specified in the study protocol as “PR and CR combined and separately” to address the secondary objective on the KS response. Due to the extremely limited number of participants with KS complete response, the Statistical Analysis Plan was updated, and the Final Analysis was conducted only on the combined KS response. The outcome on PR separately was withdrawn.
Time Frame From study treatment initiation to 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the extremely limited number of participants with KS CR, KS partial response (PR) and CR were combined. The analyses of CR and PR separately which were initially specified in the study protocol were withdrawn.
Arm/Group Title Arm A: ART Alone Period (Step 1) Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Cumulative Incidence of Initial KS Complete Response by Week 96
Hide Description KS complete response (CR) compared to study entry based on clinical evaluation of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). This was initially part of the outcome specified in the study protocol as “PR and CR combined and separately” to address the secondary objective on the KS response. Due to the extremely limited number of participants with KS CR, the Statistical Analysis Plan was updated, and the Final Analysis was conducted only on the combined KS response. The outcome on CR separately was withdrawn.
Time Frame From study treatment initiation to 96 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to the extremely limited number of participants with KS CR, KS partial response (PR) and CR were combined. The analyses of CR and PR separately which were initially specified in the study protocol were withdrawn.
Arm/Group Title Arm A: ART Alone Period (Step 1) Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis used the ART alone period (Step 1) prior to initiation of delayed ET in Step 2.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Number of Participants With Grade 3 or Higher Adverse Events
Hide Description Number of participants who experienced an AE (sign/symptom or laboratory abnormality) of Grade 3 or higher. The AEs were graded by the clinicians according to the Division of AIDS (DAIDS) AE Grading Table (see reference in the Protocol Section) as follows: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Potentially Life-Threatening.
Time Frame From study treatment dispensation through up to Week 96, until long-term follow-up began in Step 3 or until study discontinuation.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 94 96
Measure Type: Count of Participants
Unit of Measure: Participants
47
  50.0%
42
  43.8%
18.Secondary Outcome
Title Cumulative Incidence of KS-IRIS
Hide Description KS-IRIS was defined as KS progressive disease that occurs within 12 weeks of initiation of ART that is associated with an increase in peripheral blood CD4+ lymphocyte cell count of at least 50 cells/mm^3 above the study screening value and/or a decrease in the HIV RNA level by at least 0.5 log10 below the study entry value prior to, or at the time of, documented KS progressive disease. Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored (1) when lost to follow-up, (2) at the study visit following Week 12 or (3) on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier. Time of KS-IRIS was defined as the time of the initial KS progressive disease.
Time Frame From study entry to Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative events per 100 participants
23.14
(15.03 to 32.29)
7.40
(3.24 to 13.85)
19.Secondary Outcome
Title Percentage of Participants With Etoposide Dose Modification
Hide Description Etoposide (ET) was administered for a maximum of 8 cycles (16 weeks) from study entry (Arm B) or from Step 2 entry (Arm A). Dose modifications were reported as temporarily held, resumed at a different dose, deferred, prematurely discontinued and underdosed. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category.
Time Frame From ET dispensation to ET discontinuation (total duration of ET was up to 16 weeks)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment. Arm A participants are limited to those who entered Step 2 to initiate delayed ET.
Arm/Group Title Arm A: ART With Delayed ET (Step 2) Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis is limited to Arm A participants who entered Step 2 to initiate delayed ET.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 32 96
Measure Type: Number
Unit of Measure: percentage of participants
Temporarily held 0 5.2
Resumed at a different dose 15.6 9.4
Deferred 37.5 24.0
Discontinued 6.3 10.4
Underdosed 0 1
20.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA Suppression
Hide Description HIV-1 RNA suppression was defined as plasma HIV-1 RNA <400 copies/mL. Only Arm A participants could enter Step 2 to initiate delayed ET.
Time Frame Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had HIV-1 RNA results available at the specific visit. HIV-1 RNA testing was done locally using Abbott RealTime HIV-1 Test or Roche AmpliPrep/Taqman HIV-1 Test. Only Arm A participants could enter Step 2 to initiate delayed ET.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Unit of Measure: percentage of participants
Entry: HIV-1 RNA suppression Number Analyzed 94 participants 96 participants
4.3 4.2
Week 12: HIV-1 RNA suppression Number Analyzed 72 participants 85 participants
90.3 90.6
Week 24: HIV-1 RNA suppression Number Analyzed 55 participants 81 participants
94.5 97.5
Week 32: HIV-1 RNA suppression Number Analyzed 50 participants 76 participants
92.0 94.7
Week 48: HIV-1 RNA suppression Number Analyzed 43 participants 72 participants
95.3 98.6
Week 72: HIV-1 RNA suppression Number Analyzed 34 participants 58 participants
91.2 96.6
Week 96: HIV-1 RNA suppression Number Analyzed 28 participants 48 participants
92.9 93.8
Step 2 entry: HIV-1 RNA suppression Number Analyzed 30 participants 0 participants
93.3
Step 2 Week 12: HIV-1 RNA suppression Number Analyzed 27 participants 0 participants
100.0
Step 2 Week 24: HIV-1 RNA suppression Number Analyzed 24 participants 0 participants
95.8
Step 2 Week 32: HIV-1 RNA suppression Number Analyzed 25 participants 0 participants
96.0
Step 2 Week 48: HIV-1 RNA suppression Number Analyzed 18 participants 0 participants
100.0
Step 2 Week 72: HIV-1 RNA suppression Number Analyzed 12 participants 0 participants
100.0
21.Secondary Outcome
Title Percentage of Participants With ARV Dose Modification
Hide Description ARV dose modifications were reported as temporarily held, prematurely discontinued and increased. The percentage of participants who experienced each dose modification is provided in the data table below. The categories are not mutually exclusive. A participant may have experienced multiple dose modifications and may be counted in more than one category. Each participant is counted at most once within category.
Time Frame From treatment dispensation to Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 94 96
Measure Type: Number
Unit of Measure: percentage of participants
Temporarily held 7.4 11.5
Prematurely discontinued 26.6 21.9
Increased 1.1 0
22.Secondary Outcome
Title Change in log10 HIV-1 Plasma Viral Load From Entry
Hide Description Absolute change in log10 HIV-1 RNA from entry at study visits calculated as value at a given time point minus value at entry. This outcome was initially specified in the study protocol. However, at the first post-entry visit, most participants had unquantifiable HIV-1 RNA levels. It would be misleading to calculate change from entry to HIV RNA-1 levels that could not be quantified. Therefore, the data collected did not support the outcome and the analytic method initially proposed in the study protocol, and this outcome measure could not be analyzed. The SAP updated the HIV-1 RNA outcome measure to HIV-1 RNA suppression at study visits (please refer to the secondary outcome measure #20).
Time Frame Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
At the first post-entry visit, most participants had unquantifiable HIV-1 RNA levels. Therefore, this outcome measure could not be analyzed.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Change in Peripheral Blood CD4+ Lymphocyte Cell Count
Hide Description Absolute change in CD4+ cell count was calculated as value at a given visit minus the value at study screening in Step 1, and as value at a given visit minus Step 2 entry in Step 2. Only participants in Arm A could enter Step 2 to initiate delayed ET.
Time Frame Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All eligible participants who initiated study treatment and had CD4 cell count results available at screening and the respective Step 1 visit or at Step 2 entry and the respective Step 2 visit.
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study.
Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Overall Number of Participants Analyzed 94 96
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
Week 12: CD4 change Number Analyzed 71 participants 85 participants
40
(12 to 118)
67
(5 to 114)
Week 24: CD4 change Number Analyzed 55 participants 82 participants
57
(3 to 139)
121
(47 to 210)
Week 32: CD4 change Number Analyzed 49 participants 76 participants
90
(36 to 157)
119
(60 to 216)
Week 48: CD4 change Number Analyzed 43 participants 72 participants
125
(39 to 186)
121
(61 to 208)
Week 72: CD4 change Number Analyzed 34 participants 58 participants
143
(66 to 290)
125
(66 to 257)
Week 96: CD4 change Number Analyzed 28 participants 47 participants
149
(75 to 265)
206
(118 to 290)
Step 2 Week 12: CD4 change Number Analyzed 26 participants 0 participants
-13
(-74 to 83)
Step 2 Week 24: CD4 change Number Analyzed 24 participants 0 participants
-15
(-35 to 51)
Step 2 Week 32: CD4 change Number Analyzed 24 participants 0 participants
28
(-7 to 71)
Step 2 Week 48: CD4 change Number Analyzed 17 participants 0 participants
2
(-108 to 143)
Step 2 Week 72: CD4 change Number Analyzed 12 participants 0 participants
51
(-97 to 131)
24.Secondary Outcome
Title Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A
Hide Description KS progressive disease (PD) compared to Step 2 entry (prior to initiation of delayed ET) or Step 2 best response based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.
Time Frame From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Arm A participants who experienced KS progression and entered Step 2 to initiate delayed ET.
Arm/Group Title Arm A: ART With Delayed ET Period (Step 2)
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis was limited to the ART with delayed ET period (Step 2).
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative events per 100 participants
35.78
(17.74 to 54.28)
25.Secondary Outcome
Title Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A
Hide Description KS response, partial or complete (PR or CR) compared to Step 2 entry (prior to initiation of delayed ET) based on clinical assessment of KS cutaneous lesions (count, character and marker lesion area), oral KS, visceral KS and tumor-associated edema and as described in the publications (Krown et al 1989, Cianfrocca et al 2002). Cumulative incidence was estimated with death and initiation of alternate KS treatment as competing risks. Time at risk was censored at the end of Step 2 (at up to 84 weeks or premature study discontinuation) or on the date when the DSMB's recommendation to close the study became public, whichever occurred earlier.
Time Frame From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All Arm A participants who experienced KS progression and entered Step 2 to initiate delayed ET.
Arm/Group Title Arm A: ART With Delayed ET Period (Step 2)
Hide Arm/Group Description:
Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. This analysis was limited to the ART with delayed ET period (Step 2).
Overall Number of Participants Analyzed 32
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: cumulative events per 100 participants
62.57
(31.65 to 82.60)
Time Frame From study treatment dispensation to study completion at up to Week 240. The study is ongoing with participants in follow-up for long-term safety after use of ET. The AE summaries will be updated when the study has been completed.
Adverse Event Reporting Description The study protocol required reporting of all new diagnoses, signs/symptoms and laboratory events of >=Grade 3 and all signs/symptoms and laboratory events that led to a change in treatment, regardless of grade. All signs/symptoms and laboratory results that were observed or performed as part of establishing a diagnosis were requested regardless of grade. The DAIDS AE Grading Table (V1.0) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment are included.
 
Arm/Group Title Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Hide Arm/Group Description Participants were prescribed ART for 96 weeks. Arm A participants who experienced KS progression on ART alone could receive etoposide (ET) in addition to ART in Step 2 of the study. Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
All-Cause Mortality
Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Affected / at Risk (%) Affected / at Risk (%)
Total   13/94 (13.83%)   12/96 (12.50%) 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Affected / at Risk (%) Affected / at Risk (%)
Total   32/94 (34.04%)   28/96 (29.17%) 
Blood and lymphatic system disorders     
Anaemia  1  4/94 (4.26%)  3/96 (3.13%) 
Neutropenia  1  0/94 (0.00%)  1/96 (1.04%) 
Gastrointestinal disorders     
Abdominal pain upper  1  0/94 (0.00%)  1/96 (1.04%) 
General disorders     
Death  1  0/94 (0.00%)  1/96 (1.04%) 
Pyrexia  1  1/94 (1.06%)  0/96 (0.00%) 
Infections and infestations     
Bacteraemia  1  0/94 (0.00%)  2/96 (2.08%) 
Bacterial sepsis  1  1/94 (1.06%)  1/96 (1.04%) 
Cellulitis  1  2/94 (2.13%)  1/96 (1.04%) 
Disseminated cryptococcosis  1  0/94 (0.00%)  1/96 (1.04%) 
Disseminated tuberculosis  1  2/94 (2.13%)  0/96 (0.00%) 
Gastroenteritis  1  3/94 (3.19%)  0/96 (0.00%) 
Hepatitis B  1  0/94 (0.00%)  1/96 (1.04%) 
Malaria  1  1/94 (1.06%)  1/96 (1.04%) 
Meningitis  1  0/94 (0.00%)  1/96 (1.04%) 
Meningitis bacterial  1  1/94 (1.06%)  0/96 (0.00%) 
Meningitis cryptococcal  1  1/94 (1.06%)  0/96 (0.00%) 
Parotitis  1  1/94 (1.06%)  0/96 (0.00%) 
Pneumocystis jirovecii pneumonia  1  0/94 (0.00%)  1/96 (1.04%) 
Pneumonia  1  2/94 (2.13%)  5/96 (5.21%) 
Pneumonia bacterial  1  1/94 (1.06%)  1/96 (1.04%) 
Pulmonary tuberculosis  1  1/94 (1.06%)  2/96 (2.08%) 
Pyelonephritis  1  1/94 (1.06%)  0/96 (0.00%) 
Salmonella sepsis  1  0/94 (0.00%)  1/96 (1.04%) 
Salmonellosis  1  1/94 (1.06%)  0/96 (0.00%) 
Sepsis  1  2/94 (2.13%)  2/96 (2.08%) 
Septic shock  1  0/94 (0.00%)  1/96 (1.04%) 
Sinusitis  1  1/94 (1.06%)  0/96 (0.00%) 
Tuberculosis  1  1/94 (1.06%)  2/96 (2.08%) 
Upper respiratory tract infection  1  1/94 (1.06%)  0/96 (0.00%) 
Investigations     
Blood creatinine increased  1  0/94 (0.00%)  1/96 (1.04%) 
Neutrophil count decreased  1  0/94 (0.00%)  1/96 (1.04%) 
Transaminases increased  1  0/94 (0.00%)  1/96 (1.04%) 
Weight decreased  1  1/94 (1.06%)  0/96 (0.00%) 
Metabolism and nutrition disorders     
Hyponatraemia  1  0/94 (0.00%)  1/96 (1.04%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Kaposi's sarcoma  1  9/94 (9.57%)  2/96 (2.08%) 
Oesophageal carcinoma  1  0/94 (0.00%)  1/96 (1.04%) 
Renal and urinary disorders     
Acute kidney injury  1  1/94 (1.06%)  1/96 (1.04%) 
Renal failure  1  2/94 (2.13%)  1/96 (1.04%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory distress syndrome  1  0/94 (0.00%)  1/96 (1.04%) 
Pleural effusion  1  0/94 (0.00%)  3/96 (3.13%) 
Pulmonary embolism  1  0/94 (0.00%)  1/96 (1.04%) 
Respiratory failure  1  1/94 (1.06%)  0/96 (0.00%) 
Vascular disorders     
Hypertension  1  1/94 (1.06%)  0/96 (0.00%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A: ART Alone or With Delayed ET Arm B: ART With Immediate ET
Affected / at Risk (%) Affected / at Risk (%)
Total   83/94 (88.30%)   85/96 (88.54%) 
Blood and lymphatic system disorders     
Anaemia  1  7/94 (7.45%)  5/96 (5.21%) 
Lymphadenopathy  1  6/94 (6.38%)  4/96 (4.17%) 
Gastrointestinal disorders     
Abdominal pain  1  6/94 (6.38%)  8/96 (8.33%) 
Diarrhoea  1  7/94 (7.45%)  9/96 (9.38%) 
Nausea  1  4/94 (4.26%)  9/96 (9.38%) 
Vomiting  1  8/94 (8.51%)  12/96 (12.50%) 
General disorders     
Chest pain  1  7/94 (7.45%)  8/96 (8.33%) 
Malaise  1  13/94 (13.83%)  10/96 (10.42%) 
Oedema peripheral  1  13/94 (13.83%)  4/96 (4.17%) 
Peripheral swelling  1  7/94 (7.45%)  3/96 (3.13%) 
Pyrexia  1  24/94 (25.53%)  25/96 (26.04%) 
Infections and infestations     
Bacteraemia  1  2/94 (2.13%)  6/96 (6.25%) 
Bacterial sepsis  1  4/94 (4.26%)  7/96 (7.29%) 
Malaria  1  6/94 (6.38%)  5/96 (5.21%) 
Pharyngitis  1  1/94 (1.06%)  5/96 (5.21%) 
Pneumonia bacterial  1  8/94 (8.51%)  5/96 (5.21%) 
Pulmonary tuberculosis  1  3/94 (3.19%)  7/96 (7.29%) 
Upper respiratory tract infection  1  2/94 (2.13%)  9/96 (9.38%) 
Urinary tract infection  1  1/94 (1.06%)  9/96 (9.38%) 
Investigations     
Alanine aminotransferase increased  1  9/94 (9.57%)  10/96 (10.42%) 
Aspartate aminotransferase increased  1  14/94 (14.89%)  18/96 (18.75%) 
Blood albumin decreased  1  34/94 (36.17%)  32/96 (33.33%) 
Blood alkaline phosphatase increased  1  10/94 (10.64%)  6/96 (6.25%) 
Blood bicarbonate decreased  1  15/94 (15.96%)  13/96 (13.54%) 
Blood creatinine increased  1  4/94 (4.26%)  6/96 (6.25%) 
Blood phosphorus decreased  1  6/94 (6.38%)  6/96 (6.25%) 
Blood sodium decreased  1  38/94 (40.43%)  38/96 (39.58%) 
Haemoglobin decreased  1  24/94 (25.53%)  19/96 (19.79%) 
Neutrophil count decreased  1  31/94 (32.98%)  31/96 (32.29%) 
Platelet count decreased  1  2/94 (2.13%)  6/96 (6.25%) 
Weight decreased  1  9/94 (9.57%)  6/96 (6.25%) 
White blood cell count decreased  1  6/94 (6.38%)  7/96 (7.29%) 
Metabolism and nutrition disorders     
Decreased appetite  1  5/94 (5.32%)  5/96 (5.21%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  13/94 (13.83%)  7/96 (7.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma  1  7/94 (7.45%)  2/96 (2.08%) 
Kaposi's sarcoma  1  9/94 (9.57%)  13/96 (13.54%) 
Nervous system disorders     
Dizziness  1  5/94 (5.32%)  3/96 (3.13%) 
Headache  1  13/94 (13.83%)  12/96 (12.50%) 
Renal and urinary disorders     
Dysuria  1  2/94 (2.13%)  7/96 (7.29%) 
Reproductive system and breast disorders     
Vaginal discharge  1  0/94 (0.00%)  5/96 (5.21%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/94 (18.09%)  22/96 (22.92%) 
Dyspnoea  1  12/94 (12.77%)  12/96 (12.50%) 
Oropharyngeal plaque  1  5/94 (5.32%)  2/96 (2.08%) 
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Responsible Party: AIDS Clinical Trials Group
ClinicalTrials.gov Identifier: NCT01352117     History of Changes
Other Study ID Numbers: ACTG A5264
1U01AI068636 ( U.S. NIH Grant/Contract )
AMC 067 ( Other Identifier: AMC )
First Submitted: March 3, 2011
First Posted: May 11, 2011
Results First Submitted: March 17, 2017
Results First Posted: July 31, 2017
Last Update Posted: August 28, 2018