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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01352117
First Posted: May 11, 2011
Last Update Posted: November 17, 2017
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.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
AIDS Clinical Trials Group
Results First Submitted: March 17, 2017  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from November 2011 to February 2016 at 10 sites in Africa and South America.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A: ART Alone or With Delayed ET 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.
Arm B: ART With Immediate ET Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.

Participant Flow:   Overall Study
    Arm A: ART Alone or With Delayed ET   Arm B: ART With Immediate ET
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 
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible participants who initiated study treatment.

Reporting Groups
  Description
Arm A: ART Alone or With Delayed ET 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.
Arm B: ART With Immediate ET Participants were prescribed ART for 96 weeks with immediate etoposide (ET) for up to 16 weeks.
Total Total of all reporting groups

Baseline Measures
   Arm A: ART Alone or With Delayed ET   Arm B: ART With Immediate ET   Total 
Overall Participants Analyzed 
[Units: Participants]
 94   96   190 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 34 
 (28 to 41) 
 35 
 (30 to 41) 
 34 
 (29 to 41) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      66  70.2%      69  71.9%      135  71.1% 
Male      28  29.8%      27  28.1%      55  28.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Malawi   30   32   62 
Brazil   4   5   9 
Uganda   28   30   58 
Zimbabwe   9   7   16 
South Africa   6   6   12 
Kenya   15   13   28 
Peru   2   3   5 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Log10 copies/mL]
Median (Inter-Quartile Range)
 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 
[Units: Cells/mm^3]
Median (Inter-Quartile Range)
 190 
 (88 to 325) 
 165 
 (63 to 327) 
 184 
 (78 to 325) 
CD4 cell count, categorized 
[Units: Participants]
Count of 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] 
[Units: Participants]
Count of 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] Karnofsky performance scale is from 0 (dead) to 100 (normal; no complaint; no evidence of disease) by 10.
KS stage [1] 
[Units: Participants]
Count of 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] 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 
[Units: Participants]
Count of Participants
     
ART-experienced      0   0.0%      1   1.0%      1   0.5% 
ART-naive      94 100.0%      95  99.0%      189  99.5% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Kaposi Sarcoma (KS) Status at Week 48 Compared to Study Entry   [ Time Frame: Entry through Week 48. ]

2.  Secondary:   KS Progressive Disease at Week 48 Compared to Study Entry   [ Time Frame: Entry and Week 48 ]

3.  Secondary:   KS Partial Response at Week 48 Compared to Study Entry   [ Time Frame: Entry and Week 48 ]

4.  Secondary:   KS Complete Response at Week 48 Compared to Study Entry   [ Time Frame: Entry and Week 48 ]

5.  Secondary:   KS Partial or Complete Response at Week 48 Compared to Study Entry   [ Time Frame: Entry and Week 48 ]

6.  Secondary:   Premature Study Discontinuation by Week 48   [ Time Frame: Entry through Week 48 ]

7.  Secondary:   Kaposi Sarcoma (KS) Status at Week 96 Compared to Study Entry   [ Time Frame: Entry through Week 96. ]

8.  Secondary:   KS Progressive Disease at Week 96 Compared to Study Entry   [ Time Frame: Entry and Week 96 ]

9.  Secondary:   KS Partial Response at Week 96 Compared to Study Entry   [ Time Frame: Entry and Week 96 ]

10.  Secondary:   KS Complete Response at Week 96 Compared to Study Entry   [ Time Frame: Entry and Week 96 ]

11.  Secondary:   KS Partial or Complete Response at Week 96 Compared to Study Entry   [ Time Frame: Entry and Week 96 ]

12.  Secondary:   Premature Study Discontinuation by Week 96   [ Time Frame: Entry through Week 96 ]

13.  Secondary:   Cumulative Incidence of Initial KS Progressive Disease by Week 96   [ Time Frame: From entry through 96 weeks ]

14.  Secondary:   Cumulative Incidence of Initial KS Partial or Complete Response by Week 96   [ Time Frame: From entry through 96 weeks ]

15.  Secondary:   Cumulative Incidence of Initial KS Partial Response by Week 96   [ Time Frame: From study treatment initiation to 96 weeks ]

16.  Secondary:   Cumulative Incidence of Initial KS Complete Response by Week 96   [ Time Frame: From study treatment initiation to 96 weeks ]

17.  Secondary:   Number of Participants With Grade 3 or Higher Adverse Events   [ Time Frame: From study treatment dispensation through up to Week 96, until long-term follow-up began in Step 3 or until study discontinuation. ]

18.  Secondary:   Cumulative Incidence of KS-IRIS   [ Time Frame: From study entry to Week 12 ]

19.  Secondary:   Percentage of Participants With Etoposide Dose Modification   [ Time Frame: From ET dispensation to ET discontinuation (total duration of ET was up to 16 weeks) ]

20.  Secondary:   Percentage of Participants With HIV-1 RNA Suppression   [ Time Frame: Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72. ]

21.  Secondary:   Percentage of Participants With ARV Dose Modification   [ Time Frame: From treatment dispensation to Week 96 ]

22.  Secondary:   Change in log10 HIV-1 Plasma Viral Load From Entry   [ Time Frame: Entry and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72. ]

23.  Secondary:   Change in Peripheral Blood CD4+ Lymphocyte Cell Count   [ Time Frame: Screening and Weeks 12, 24, 32, 48, 72, 96; Step 2 entry and Weeks 12, 24, 32, 48 and 72. ]

24.  Secondary:   Cumulative Incidence of KS Progressive Disease After Initiation of Delayed Etoposide in Arm A   [ Time Frame: From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2) ]

25.  Secondary:   Cumulative Incidence of KS Response After Initiation of Delayed Etoposide in Arm A   [ Time Frame: From initiation of etoposide (Step 2 entry) to up to 84 weeks (end of Step 2) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI 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
e-mail: ACTGCT.Gov@s-3.com


Publications:

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: November 17, 2017