Study | Setting | Randomisation level | Study population (main criteria) | Intervention | Outcome(s) | Expected date of results |
---|---|---|---|---|---|---|
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 |