Prednisone with early ART in HIV-TB

Preventing Tuberculosis-associated Immune Reconstitution Inflammatory Syndrome in high-risk patients: a randomised placebo-controlled trial of prednisone

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201304000511413

Enrollment

240

Registered

2013-02-26

Start date

2013-07-01

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Tuberculosis

Interventions

Prednisone

Placebo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: HIV infection CD 4 count equal to or less than 100 cells/microlitre ART naieve Confirmed diagnosis of TB On TB treatment for less than 30 days prior to study entry Eligible for ART and consent to start ART within 30 days of starting TB treatment Written informed consent for trial

Exclusion criteria

Exclusion criteria: Kaposi's sarcoma Pregnancy Younger than 18 years of age TB Meningitis or tuberculoma at TB diagnosis

Design outcomes

Primary

Measure	Time frame
The development of paradoxical TB-IRIS within 12 weeks of starting ART (defined using the International Network for the Study of HIV-associated IRIS (INSHI) consensus case definition	—

Secondary

Measure	Time frame
Time to TB-IRIS event;Severity of TB-IRIS event;Duration of TB-IRIS event;Mortality attributed to TB and TB-IRIS;All-cause mortality;Other (non-TB) IRIS events;Quality of life assessment	—

Countries

South Africa

Contacts

Public ContactCharlotte Schutz

Medical Officer

Charlotte.Schutz@uct.ac.za+27 21 4066389

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026