Codebook for “Efficacy and safety of discontinuing cotrimoxazole prophylaxis among HIV infected adults stabilized on ART in Uganda”

Permanent Identifier:

https://doi.org/10.17037/DATA.00000917

Variable description

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.

1. “COSTOP Adherence-ART-CTX-ITN” dataset

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

2. “COSTOP All cause mortality” dataset

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

3. “COSTOP All grade 3-4 haematological AEs” dataset

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

4. “COSTOP CD4 counts at 48 weeks” dataset

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

5. “COSTOP COSTOP baseline x'tics” dataset

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

6. “COSTOP Laboratory parameters at week 48” dataset

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

7. “COSTOP Number of episodes of haematological grade 3-4 AEs” dataset

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

8. “COSTOP Sensitivity analysis” dataset

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

9. “COSTOP Time to first CTX preventable event” dataset

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

10. “COSTOP Time to first grade 3-4” dataset

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

11. “COSTOP Time to first hospital admission” dataset

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

12. “COSTOP Time to first SAE” dataset

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