Table 3.

Summary of ongoing trials examining timing of antiretroviral (ART) initiation in HIV-associated tuberculosis (TB)

Trial and sponsor	Setting and sample size	Type of tuberculosis	CD4 count at entry (cells/μL)	ART regimen	Treatment arms	Duration of follow-up	Primary outcome measure(s)
SAPIT (follow-up of arms 1 and 2): A study to compare three existing time points for starting ART in HIV/TB patients. Centre for the AIDS Programme of Research in South Africa (NCT00398996)	South Africa N=429	Smear positive pulmonary TB	<500	Didanosine, lamivudive efavirenz	Arm 1: ART within first 4 weeks. Arm 2: ART within 4 weeks of completion of intensive phase	18 months	All cause mortality and progression to AIDS-defining illness
TB-HAART: An evaluation of the impact of early initiation of HAART on TB treatment outcomes for HIV/TB patients (ISRCTN77861053), WHO / TDR	South Africa, Uganda, Zambia, Tanzania N=1900	Smear and culture positive pulmonary TB	220 – 500	Zidovudine lamivudine, efavirenz	Arm 1: ART initiation at 2 weeks Arm 2: Placebo for 6 months followed by ART	24 months	Composite endpoint of TB treatment failure or death at 6 months after initiation of TB treatment
ACTG A5221: Immediate versus deferred start of ART in HIV-infected adults being treated for tuberculosis (NCT00108862), NIAID	USA, Brazil, Haiti, South Africa, Kenya, Malawi, India, Thailand. N = 800	Confirmed or probable TB	<200	Tenofovir, emtricitabine, efavirenz	Arm 1: ART initiation at 2 weeks Arm 2: ART initiation at 8 to 12 weeks	48 weeks	Survival without progression to AIDS
Anti-HIV Drugs for Ugandan Patients with HIV and Tuberculosis (NCT00078247) NIAID	Uganda N=350	Smear or culture positive pulmonary TB	>350	Zidovudine, lamivudine, abacavir	Arm 1: immediate ART for 6 months Arm 2: ART delayed until CD4 count <250 cells/mm3	2 years	CD4 count decline and progression to AIDS
TIME: Appropriate timing of HAART in co-infected HIV/TB patients (NCT01014481), Bamrasnaradura Infectious Diseases Institute	Thailand N=210	Clinical or smear or culture positive TB	<350	Tenofovir, lamivudine, efavirenz	Arm 1: ART initiation after 4 weeks Arm 2: ART initiation after 12 weeks	144 weeks	Composite endpoint of death rate, hospitalization rate and adverse drug reactions
Simultaneous versus sequential ART and TB treatment (NCT00737724), Instituto Nacional de Enfermedades Respiratorias	Mexico N=160	Active pulmonary TB	<200	Tenofovir, emtricitabine, efavirenz	Arm 1: immediate ART Arm 2: ART initiation after 2 months	96 weeks	1.Signs and symptoms of active tuberculosis 2.Mycobacterial load in body fluids or affected tissues