| Protocol No: | ECCT/15/11/01 | Date of Protocol: | 04-08-2010 |
| Study Title: |
A Randomized Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy
versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for Treatment of
Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS)
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| Study Objectives: | |
| Laymans Summary: | |
| Abstract of Study: |
ABSTRACT
The study titled “A Randomized Evaluation of Antiretroviral Therapy Alone or with
Delayed Chemotherapy versus Antiretroviral Therapy with Immediate Adjunctive
Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited
Settings (REACT-KS)” is a phase III, open-label, prospective, randomized study
stratified by CD4+ lymphocyte cell count and antiretroviral therapy (ART) history.
This study will compare ART alone, or with delayed chemotherapy to ART with
immediate adjunctive chemotherapy for initial treatment of limited stage AIDSrelated
Kaposi’s sarcoma (AIDS-KS), in chemotherapy and radiation treatment naïve
HIV-1 infected participants who are currently not receiving ART.
The target population includes males and females 18 years of age with the
following characteristics: documentation of HIV-1 infection, biopsy diagnostic of KS,
current limited stage KS (T0 and some T1 stage KS), systemic chemotherapy for KS
and radiation treatment naïve, and currently not receiving ART. A total of 468
participants (234 in each Arm of Step 1) will be enrolled across all sites, with the
KEMRI/CDC site proposing to contribute about 50 participants, and could be
more given enrollment across sites is competitive. Randomization will be stratified
by screening peripheral blood CD4+ lymphocyte cell count (< 200 or 200
cells/mm³) and ART history (naïve or experienced). At study entry participants will
be randomized 1:1 to one of the following arms in Step 1: Arm 1A, Co-formulated
efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) and arm 1B,
co-formulated EFV/FTC/TDF and ET. In Step 2, at the discretion of the site
investigator, after confirmation of disease progression by the IERC (Independent
Endpoint Review Committee), participants who experience KS progression in Arm
1A will receive ET in addition to co-formulated EFV/FTC/TDF. In step 3,
participants who received ET will remain on the study for 240 weeks (96 weeks +
144 weeks of follow-up for safety). Participants never receiving etoposide (VePesid®,
ET) will be followed up for 96 weeks.
The primary endpoint incorporates KS tumor response, KS progression, loss to
follow-up, and initiation of new chemotherapy agent other than ET, as an ordinal,
categorical outcome i.e. failure, stable and respose. The main interest of the study is
the outcome at 48 weeks after the treatment initiation. KS follow-up to 96 weeks of
SSA (Protocol No ACTG A5264), Version 1.1 Page 5 of 96
the study will allow assessments of study arm differences beyond 48 weeks. The
primary analysis will be conducted when the data on 96-week follow-up are
completed on all the study participants (at Step 2 completion).
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