|
PrOMPTa[24]
|
Gabon, Mozambique, South Africa, Uganda
|
Individual
|
CD4 count <50 and body mass index <18; no previous TB treatment; aged ≥18 years; Sputum smear negative; and not fulfilling World Health Organization criteria for smear-negative TB.
|
4-drug TB treatment, followed by ART within 2 weeks. Comparator: ART alone
|
Primary: all-cause mortality in the first 24 weeks after initiation of ART, CD4 cell increase, safety, HIV viral suppression, TB incidence after ART initiation
|
N/A
|
|
REMEMBER [25]
|
Brazil, Haiti, India, Kenya, Malawi, Peru, South Africa, Tanzania, Zimbabwe
|
Individual
|
CD4 count <50; aged ≥13 years; Karnofsky ≥30; no previous TB treatment (within 96 weeks). Those with confirmed or probable TB excluded.
|
ART initiation within 3 days and 4-drug TB treatment within 7 days of ART start. Comparator: ART initiation within 3 days
|
Primary: survival at 24 weeks; survival over 96 weeks; time to AIDS progression; AIDS-free survival at 24 and 28 weeks; HIV viral load at 2, 24 and 48 weeks; safety
|
May 2016
|
|
REMSTART [27]
|
Tanzania, Zambia
|
Individual
|
Initially CD4 count <100, broadened to <200 following slow enrolment; aged ≥18 years. All screened for TB at enrolment with Xpert MTB/RIF
|
Rapid initiation of ART, screening for cryptococcal antigen, weekly home visits for 4 weeks by lay workers and rescreening for TB using Xpert MTB/RIF at 6 weeks. Comparator: standard of care
|
Primary: all-cause mortality at 12 months, patient retention, hospital admission, outpatient attendances, TB, cryptococcal meningitis, ART adherence
|
Dec 2014
|
|
REALITY [28]
|
Kenya, Malawi, Uganda, Zimbabwe
|
Individual
|
CD4 count <100, aged ≥5 years
|
2x2x2 factorial: a) intensified ART (triple therapy plus raltegravir) for 12 weeks; b) multidrug prophylaxis against co-infections (isoniazid, pyridoxine, co-trimoxazole and fluconazole for 12 weeks; azithromycin for 5 days; single dose albendazole); c) ready-to-use supplementary food for 12 weeks. Comparator: standard of care including co-trimoxazole, with isoniazid and pyridoxine after 12 weeks
|
Primary: mortality over the first 24 weeks after starting ART, mortality at 48 weeks after starting ART, safety, endpoints relating to the specific mechanisms of action of each intervention
|
Aug 2015
|
|
STATIS [26]
|
Cambodia, Côte d’Ivoire, Uganda, Vietnam
|
Individual
|
CD4 count <100; starting ART; aged ≥18 years. Excluded if overt evidence of TB
|
Empirical treatment. Comparator: extensive TB screening (point of care urine lipoarabinomannan, sputum Xpert MTB/RIF, chest radiograph for all at enrolment and those with TB symptoms or signs at all follow-up visits)
|
Primary: composite of (i) 24-week all-cause mortality and (ii) 24-week incidence of invasive bacterial infections; incidence of TB; safety
|
Jun 2017
|
|
TB Fast Track [23]
|
South Africa
|
Clinic
|
CD4 count ≤150; not on ART and willing to start ART; aged ≥18 years. No pre-screening for TB prior to enrolment
|
Management strategy to identify those at highest risk of TB, so that they can start TB treatment immediately, followed by ART. Comparator: standard of care
|
Primary: 6-month mortality, severe morbidity over 6 months, time to initiation of ART, retention in ART care, safety
|
Dec 2015
|
