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
Tahapan Penelitian : Initial
Sponsor:
The Aurum Institute
Mitra Pelaksana:
George Clinical, Equilab
No Registry
INA-MXAATHZ
Tanggal Input Registry : 03-10-2023
| Tracking Information | |
|---|---|
| Tanggal Antisipasi Studi | 01-11-2023 |
| Outcome Primer | Successful completion of TPT with >90% adherence documented by self-report, pill count, and EMD reporting |
| Outcome Skunder | Safety of treatment regimens, defined as occurrence of Grade 2 or higher targeted safety events and discontinuation of study medications because of side effects. Targeted safety events are hypersensitivity syndrome, rash, seizure, peripheral neuropathy, hepatotoxicity, nausea and vomiting, and drug-related fever |
| 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 |
| 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 |
| Jenis Penelitian | Interventional |
| Intervensi | 1HP (daily isoniazid 300 mg and rifapentine 600 mg for one month/28 days) |
| Jumlah Subyek Penelitian | 250 |
| Recruitment Information | |
| Eligibility Criteria | Inclusion Criteria: Age ≥ 13 years, Weight > 30 kg, HIV-negative, Household contact of an adult with confirmed rifampicin-sensitive pulmonary TB, Candidates must meet WHO criteria for receiving TPExclusion 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 contraception, On prohibited medications |
| Administrative Information | |
| Nomor Persetujuan Etik | 83.A.2/KEPK-RSUPP/08/2023 |
| Nomor Persetujuan Material Transfer Agreement | Not applicable |
| Nomor Persetujuan Pelaksanaan Uji Klinik | PPUK/PPUB number |
| Other Study ID Numbers | |
| Contact Person | Aulia Rizkia |