Table 3

Study schedule of enrolment, interventions and assessments.

Study period
EnrolmentAllocationIntensive phase of ATT
(Trial period)
Continuation phase of ATT
(Post-trial period)
Closeout
IEnrolmentBaseline
(-D7)
W
0
W
1
W
2
W
3
W
4
W
5
W
6
W
7
W
8
M
3
M
4
M
5
M
6
M
7
1 Informed consentx
2 Eligibility screen (including laboratory tests)x
3 Sputum Gene Xpertx
4 HIV, hepatitis B and Cx
II.Allocationx
IIITrial regimens
 Test regimen (metformin containing ATT)xxxxxxxxx
 Control regimen (only ATT)xxxxxxxx
 Continuation phase of ATT
 (for both groups)
xxxx
IVAssessments
1 Clinical evaluationxxxxxxxxxxxxxxx
2 Sociological assessmentxxxxxxxxx
3 Sputum smear and culture (MGIT, LJ)xxxxxxxxxxxxx
4 Urine pregnancy tests/sugar/Albxxxxxxx
5 HbA1cxxx
6 CBC, LFT, RFT, lactic acid, peripheral smear and chest X-rayxxxx
7 Random blood sugarxxxxxx
8 Pharmacokinetics and genomicsxx
9 Immunological studiesxxx
10 Storage plasma/cell samplexxxx
VOutcomesx