A RANDOMIZED TRIAL COMPARING TREATMENT COMPLETION OF DAILY RIFAPENTINE & ISONIAZID FOR ONE MONTH (1HP) TO WEEKLY RIFAPENTINE & ISONIAZID FOR 3 MONTHS (3HP) IN PERSONS LIVING WITH HIV AND IN HIV-NEGATIVE HOUSEHOLD CONTACTS OF RECENTLY DIAGNOSED TUBERCULOSIS PATIENTS, THE “ONE TO THREE” TRIAL
Tahapan Penelitian : Recruit
Sponsor:
The Aurum Institute, NPC
Mitra Pelaksana:
PT. Equilab International
No Registry
INA-6Y0ZX7MW
Tanggal Input Registry : 27-03-2025
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 24-05-2024 |
| Outcome Primer | In the 1HP arm is taking ≥ 26 doses in a 6-week period (maximum of 2 missed doses to achieve >90% adherence), In the 3HP arm is taking ≥ 11 doses in an 18-week period (maximum of 1 missed dose to achieve >90% adherence) |
| Outcome Skunder | |
| Descriptive Information | |
| Judul Penelitian Popular | A RANDOMIZED TRIAL COMPARING TREATMENT COMPLETION OF DAILY RIFAPENTINE & ISONIAZID FOR ONE MONTH (1HP) TO WEEKLY RIFAPENTINE & ISONIAZID FOR 3 MONTHS (3HP) IN PERSONS LIVING WITH HIV AND IN HIV-NEGATIVE HOUSEHOLD CONTACTS OF RECENTLY DIAGNOSED TUBERCULOSIS PATIENTS, THE “ONE TO THREE” TRIAL |
| Judul Penelitian Ilmiah | A RANDOMIZED TRIAL COMPARING TREATMENT COMPLETION OF DAILY RIFAPENTINE & ISONIAZID FOR ONE MONTH (1HP) TO WEEKLY RIFAPENTINE & ISONIAZID FOR 3 MONTHS (3HP) IN PERSONS LIVING WITH HIV AND IN HIV-NEGATIVE HOUSEHOLD CONTACTS OF RECENTLY DIAGNOSED TUBERCULOSIS PATIENTS, THE “ONE TO THREE” TRIAL |
| Jenis Penelitian | Interventional |
| Intervensi | Two hundred and fifty participants age ≥13 who are HIV-negative household contacts of adults with confirmed pulmonary TB. Safety labs (AST, ALT, total bili) will be obtained at screening, and as clinically indicated. Urine pregnancy test for women of childbearing potential will be conducted at screening (prior to CXR), at enrolment (prior to initiating HP), prior to any X-ray, and with any clinical concern. Two hundred and fifty participants age ≥13 who are HIV-negative household contacts of adults with confirmed pulmonary TB. Safety labs (AST, ALT, total bili) will be obtained at screening, and as clinically indicated. Urine pregnancy test for women of childbearing potential will be conducted at screening (prior to CXR), at enrolment (prior to initiating HP), prior to any X-ray, and with any clinical concern. |
| Jumlah Subyek Penelitian | 300 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Aged above 13 years old, weight above 30 kg, HIV-negative, household contact of an adult with confirmed rifampicin-sensitive pulmonary TB, candidates must meet WHO criteria for receiving TPTExclusion Criteria: Confirmed or suspected TB disease (evidenced by symptoms and/or clinical exam findings and/or chest radiographic findings suggestive of TB, positive mycobacterial culture or molecular TB testing or currently on TB treatment for active TB disease), Likely to move from the study area during the study period, Known exposure to TB cases with resistance to isoniazid or rifampicin in the source case, Previous treatment for active or latent TB for >30 days within the past 2 years, Known sensitivity or intolerance to isoniazid or rifamycins, Suspected acute hepatitis or known chronic or unstable liver disease, ALT > 3 times the upper limit of normal (ULN), Total bilirubin > 2.5 times the ULN, Pregnancy or breastfeeding, Females of childbearing potential who are unable or unwilling to use two forms of acceptable contraception, On prohibited medications |
| Administrative Information | |
| Nomor Persetujuan Etik | 83/KEPK-RSUPP/09/2022 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Vicky Achmad Ginanjar |