Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3

PHASE4CompletedINTERVENTIONAL
Enrollment

1,050

Participants

Timeline

Start Date

September 30, 2014

Primary Completion Date

April 30, 2018

Study Completion Date

April 30, 2018

Conditions
HIV-1 Infection
Interventions
DEVICE

Xpert MTB/RIF®, Determine TB LAM, Chest X-ray

"The following point-of-care TB tests will be systematically performed:~Xpert MTB/RIF® on sputum (in all patients able to provide sputum; no sputum induction will be requested in others), Urine LAM (all patients). Depending on clinical presentation, Xpert MTB/RIF® will also be performed on any relevant extra-pulmonary specimen.~TB treatment will depend on the result of the tests:~Criteria met for confirmed or probable TB : TB treatment will be initiated immediately (Visit 1) followed by ART initiation 2 weeks later (Visit 2); No evidence of confirmed or probable TB: ART will be started immediately (Visit 1)."

DRUG

ART (Atripla, Truvada, Efavirenz, Combivir)

"* ART (TDF-3TC/FTC or AZT-3TC + efavirenz) will be started immediately after randomization in patients not put on TB treatment, and 2 weeks after initiation of TB treatment in others.~* ART will be initiated 2 weeks after the onset of TB treatment (V2) for Arm 2"

DRUG

Rifampin, isoniazid, pyrazinamide, ethambutol

Arm 1: Only patients who meet standardized criteria for TB at inclusion or during follow-up will receive a standard TB treatment (2ERHZ/4RH); Arm 2: • All patients will start a 6-month standard TB treatment (2ERHZ/4RH) at randomization

Trial Locations (4)

1954

CePReF Centre de Prise en charge de Recherche et de Formation, Abidjan

1956

ISS ImmunoSuppression Service, Mbarara

2318

Sihanouk Hospital Center of Hope, Phnom Penh

Unknown

Pham Ngoc Thach Hospital, Ho Chi Minh City

All Listed Sponsors
lead

ANRS, Emerging Infectious Diseases

OTHER_GOV

NCT02057796 - Systematic Empirical vs. Test-guided Anti-TB Treatment Impact in Severely Immunosuppressed HIV-infected Adults Initiating ART With CD4 Cell Counts <100/mm3 | Biotech Hunter | Biotech Hunter