NCT04738812View on ClinicalTrials.gov

Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,330

Participants

Timeline

Start Date

April 21, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
TuberculosisHIV-1-infectionImmuno-Deficiency
Interventions
DRUG

Intensified TB treatment (initial phase)

"8 weeks of RHEZ with high dose of rifampicin (R) and isoniazid (H). Fixed dose combination (FDC) of RHZE with the addition of FDC of RH and single caps of R.~6 weeks of prednisone with tapering doses. 3 days of albendazole 400 mg."

DRUG

WHO standard TB treatment (initial phase)

8 weeks of RHEZ with FDC.

Trial Locations (6)

Unknown

National Center for HIV/AIDS, Dermatology and STD (NCHADS), Phnom Penh

Jamot Hospital, Yaoundé

Ignace Deen Hospital, Conakry

MACHAVA Hospital, Maputo

Mbarara Regional Referral hospital, Mbarara

University Teaching Hospital, Lusaka

All Listed Sponsors
collaborator

European Union

OTHER

collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

lead

ANRS, Emerging Infectious Diseases

OTHER_GOV

NCT04738812 - Determination of Adequate Tuberculosis Regimen in Patients Hospitalized With HIV-associated Severe Immune Suppression | Biotech Hunter | Biotech Hunter