https://doi.org/10.17037/DATA.00000917
This data collection contains 12 datasets associated with the COSTOP randomised controlled trial, which sought to assess the safety of discontinuing Cotrimoxazole prophylaxis among HIV infected adults on ART in Uganda. The tables outlined below lists variables provided on deposit to the LSHTM data repository. To protect participant confidentiality, some variables may require redaction prior to being provided to researchers.
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | COSTOP Trial Number | Open ended | String | |
ad_wkno | Week for adherence | Open ended | Integer | |
site | Study site | Binary variable | Location not available | Numeric |
cdstrat | CD4 stratum | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
trtarm | Treatment arm | Binary variable | 1=”Ctx”, 2=”Placebo” | Numeric |
admiss | Missed CTX | Binary variable | 0=”Did not miss CTX”, 1=”missed CTX” | Numeric |
itn_no | Failed to use ITN | Binary variable | 0=”Did not miss ITN”, 1=”missed ITN” | Numeric |
artmiss | Missed ART | Binary variable | 0=”Did not miss ART”, 1=”missed ART” | Numeric |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
site | Study site | Binary variable | Location not available | Numeric |
cdstrat | CD4 stratum | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
trtarm | Treatment arm | Binary variable | 1=”Ctx”, 2=”Placebo” | Numeric |
dethvent | Whether or not participant died | Open ended | Numeric | |
enroldate | Enrolment date | Open ended | Long integer (date) | |
date_death | Date of death | Open ended | Long integer (date) | |
lasvdatb | Last visit date | Open ended | Long integer (date) | |
flupdays | Days followed up | Open ended | Integer |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
rundate | Date of hematological grade 3 / 4 AE (multiple events) | Open ended | long | |
enroldate | Enrolment date | Open ended | double | |
hemob | Hematological grade 3 / 4 AE (multiple events) | Binary variable | Numeric | |
site | Study site | Binary variable | Location not available | Numeric |
cdstrat | CD4 stratum | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
trtarm | Treatment arm | Binary variable | 1=”Ctx”, 2=”Placebo” | Numeric |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
site | Study site | Binary variable | Location not available | Numeric |
trtarm | Treatment arm | Binary variable | 1=”Ctx”, 2=”Placebo” | Numeric |
cd4bas | CD4 count at baseline | Open ended | Numeric | |
cd4flup | CD4 count closest to 48 weeks | Open ended | Numeric | |
cd4del | Change in CD4 count from baseline: cd4del= cd4flup – cd4bas | Open ended | Numeric | |
daydel | Number of days between baseline and cd4 follow-up date (48x7 = 336 days, but there is considerable variation in this) | Open ended | Numeric |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
sex | Sex | Open ended | Numeric | |
ageyrs | Age in years | Open ended | Numeric | |
site | Study site | Binary variable | Location not available | Numeric |
weight | Weight | Open ended | Numeric | |
bmi | Body Mass Index | Open ended | Numeric | |
disclose | HIV status disclosure to partner | Binary variable | 1=”Yes”, 2=”No” | Numeric |
educnu | Highest level of education | Open ended | 1=”None”, 2=”Primary”, 3=”Secondary”, 4=”Tertiary” | Numeric |
marnu | Marital status | Open ended | 1=”married or cohabiting” 3=”separated, divorced or widowed” 7=”single never married” | Numeric |
last_miss_art | Last missed ART | Open ended | Numeric | |
cd4rando | CD4 Count at randomisation | Open ended | Integer | |
cd4grp2 | RECODE of cd4rando | Open ended | Numeric | |
init_artreg | Initial ART regimen | Numeric | ||
init_artreg | Initial ART regimen | Numeric | ||
PI 2nd line | 10231 | |||
AZT/3TC/d4T | 10304 | |||
AZT/3TC/ABC | 10305 | |||
AZT/3TC/TDF | 10314 | |||
AZT/3TC/NVP | 10316 | |||
AZT/3TC/ETV | 10318 | |||
AZT/3TC/EFZ | 10319 | |||
PI 2nd line | 10331 | |||
AZT/d4T/NVP | 10416 | |||
PI 2nd line | 11931 | |||
ddI/3TC/NVP | 20316 | |||
PI 2nd line | 20531 | |||
PI 2nd line | 21931 | |||
d4T/3TC/NVP | 30416 | |||
d4T/3TC/EFZ | 30419 | |||
TDF/3TC/NVP | 31416 | |||
TDF/3TC/Aluvia | 31431 | |||
PI 2nd line | 31630 | |||
PI 2nd line | 33016 | |||
PI 2nd line | 33119 | |||
d4T/3TC/RTV | 40323 | |||
PI 2nd line | 50131 | |||
PI 2nd line | 50231 | |||
PI 2nd line | 50330 | |||
TDF/FTC/EFZ | 61419 | |||
PI 2nd line | 140623 | |||
PI 2nd line | 140631 | |||
PI 2nd line | 143103 | |||
PI 2nd line | 193100 | |||
PI 2nd line | 301603 | |||
PI 2nd line | 310014 | |||
PI 2nd line | 310119 | |||
PI 2nd line | 310216 | |||
PI 2nd line | 310219 | |||
PI 2nd line | 310319 | |||
PI 2nd line | 310503 | |||
PI 2nd line | 310511 | |||
PI 2nd line | 311100 | |||
PI 2nd line | 311600 | |||
PI 2nd line | 311900 | |||
PI 2nd line | 311902 | |||
PI 2nd line | 3140531 | |||
PI 2nd line | 3352314 | |||
PI 2nd line | 5140331 | |||
PI 2nd line | 25000000 | |||
baseline_artreg | ART regimen at screening | Numeric | ||
PI 2nd line | 10231 | |||
AZT/3TC/d4T | 10304 | |||
AZT/3TC/ABC | 10305 | |||
AZT/3TC/TDF | 10314 | |||
AZT/3TC/NVP | 10316 | |||
AZT/3TC/ETV | 10318 | |||
AZT/3TC/EFZ | 10319 | |||
PI 2nd line | 10331 | |||
AZT/d4T/NVP | 10416 | |||
PI 2nd line | 11931 | |||
ddI/3TC/NVP | 20316 | |||
PI 2nd line | 20531 | |||
PI 2nd line | 21931 | |||
d4T/3TC/NVP | 30416 | |||
d4T/3TC/EFZ | 30419 | |||
TDF/3TC/NVP | 31416 | |||
TDF/3TC/Aluvia | 31431 | |||
PI 2nd line | 31630 | |||
PI 2nd line | 33016 | |||
PI 2nd line | 33119 | |||
d4T/3TC/RTV | 40323 | |||
PI 2nd line | 50131 | |||
PI 2nd line | 50231 | |||
PI 2nd line | 50330 | |||
TDF/FTC/EFZ | 61419 | |||
PI 2nd line | 140623 | |||
PI 2nd line | 140631 | |||
PI 2nd line | 143103 | |||
PI 2nd line | 193100 | |||
PI 2nd line | 301603 | |||
PI 2nd line | 310014 | |||
PI 2nd line | 310119 | |||
PI 2nd line | 310216 | |||
PI 2nd line | 310219 | |||
PI 2nd line | 310319 | |||
PI 2nd line | 310503 | |||
PI 2nd line | 310511 | |||
PI 2nd line | 311100 | |||
PI 2nd line | 311600 | |||
PI 2nd line | 311900 | |||
PI 2nd line | 311902 | |||
PI 2nd line | 3140531 | |||
PI 2nd line | 3352314 | |||
PI 2nd line | 5140331 | |||
PI 2nd line | 25000000 | |||
artswitch | Has participant had ART switch | Open ended | Numeric | |
artdurn | Duration on ART in months | Open ended | Integer | |
whostbas | WHO stage at baseline | Open ended | Numeric | |
cdstrat | CD4 stratum | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
site | Study site | Binary variable | Location not available | Numeric |
cdstrat | CD4 stratum | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
trtarm | Treatment arm | Binary variable | 1=”Ctx”, 2=”Placebo” | Numeric |
wbcbas | Baseline WBC | Open ended | Numeric | |
hgbas | Baseline hemoglobin | Open ended | Numeric | |
pltbas | Baseline platelets | Open ended | Numeric | |
nebas | Baseline neutrophils | Open ended | Numeric | |
wbcflup | Follow-up WBC | Open ended | Numeric | |
hgflup | Follow-up hemoglobin | Open ended | Numeric | |
pltflup | Follow-up platelets | Open ended | Numeric | |
neflup | Follow-up neutrophils | Open ended | Numeric | |
wbcdel | Change in WBC | Open ended | Numeric | |
nedel | Change in neutrophils | Open ended | Numeric | |
hgdel | Change in hemoglobin | Open ended | Numeric | |
pltdel | Change in platelets | Open ended | Numeric | |
daydel | Days between baseline and followup values | Open ended | Numeric |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
site | Study site | Binary variable | Location not available | Numeric |
cdstrat | CD4 stratum | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
trtarm | Treatment arm | Binary variable | 1=”Ctx”, 2=”Placebo” | Numeric |
t3sodes | Number of episodes of thrombocytopenia | Open ended | Numeric | |
n3sodes | Number of episodes of neutropenia | Open ended | Numeric | |
a3sodes | Number of episodes of anaemia | Open ended | Numeric | |
hemasodes | Number of grade 3 / 4 hematological AEs | Open ended | Numeric |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
site | Study site | Binary variable | Location not available | Numeric |
cdstrat | CD4 stratum | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
trtarm | Treatment arm | Binary variable | 1=”Ctx”, 2=”Placebo” | long |
ctxventa | Experienced a CTX-preventable event (as adjudicated by the ERC) | Binary variable | 1=”yes”, 2=”no” | Numeric |
ctxol | Took open label CTX | Open ended | 1=”yes”, 0=”no” | Numeric |
flupdays | Days followed up | Open ended | Integer |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
q4eventdate | 4. What is the agreed event date? | Open ended | Long integer (date) | |
descvent | Event description | Open ended | String | |
site | Study site | Binary variable | Location not available | Numeric |
cdstrat | CD4 stratum | Binary variable | Location not available | Numeric |
trtarm | Treatment arm | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
enroldate | Enrolment date | Open ended | Long integer (date) | |
date_death | Date of death | Open ended | Long integer (date) | |
lasvdatb | Last visit date (ITT) | Open ended | Long integer (date) | |
lasvdatp | Last visit date (PP) | Open ended | Long integer (date) | |
ctxventa | CTX preventable event? | Binary variable | 1=”yes”, 0=”no” | Numeric |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
enroldate | Enrolment date | Open ended | Long integer | |
site | Study site | Binary variable | Location not available | Numeric |
cdstrat | CD4 stratum | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
trtarm | Treatment arm | Binary variable | 1=”Ctx”, 2=”Placebo” | Numeric |
rundate | Date of hematological grade 3 / 4 AE | Open ended | Long integer | |
hemo | Experienced grade 3 / 4 hematological AE | Binary variable | 0=”no”, 1=”yes” | Numeric |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
enroldate | Enrolment date | Open ended | Long integer | |
lasvdatb | Last visit date | Open ended | Long integer | |
site | Study site | Binary variable | Location not available | Numeric |
cdstrat | CD4 stratum | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
trtarm | Treatment arm | Binary variable | 1=”Ctx”, 2=”Placebo” | Numeric |
hospad | Hospital admission | Binary variable | (0=”no”, 1=”yes” | Numeric |
hs_admdate | Date of admission | Open ended | Long integer | |
flupdays | Days followed up | Open ended | Long integer |
Variable Name | Variable Label | Answer Label | Answer Code | Variable Type |
ctxno | Trial Number | Open ended | String | |
enroldate | Enrolment date | Open ended | Integer | |
lasvdatb | Last visit date | Open ended | Integer | |
site | Study site | Binary variable | Location not available | Numeric |
cdstrat | CD4 stratum | Binary variable | 1=”250-499”, 2=”500 or more” | Numeric |
trtarm | Treatment arm | Binary variable | 1=”Ctx”, 2=”Placebo” | Numeric |
sae | Serious adverse event | Binary variable | 0=”no”, 1=”yes” | Numeric |
saedate | Date serious adverse event occurred | Open ended | Long integer | |
flupdays | Days followed up | Open ended | Integer |