Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: Nivolumab (PD-1) treatment along with standard ATT treatment in DS and DR TB patients: The anti-PD-1 antibody Nivolumab (BMS-936558, ONO-4538, or MDX1106, trade name Opdivo
Bristol-Myers Squibb, Princeton, NJ, USA) is the first-in-human immunoglobulin G4 (IgG4) PD-1 immune checkpoint inhibitor antibody that disrupts the interaction of the PD-1 receptor with its ligands P
Sponsors
Department of Biotechnology
Eligibility
Inclusion criteria
Inclusion criteria: Patients of 18 to 60 yrs of age; either sex. 2. DR-TB patients. 3. DS-TB patients.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity anti-TB drugs. 2. Presence of secondary immunodeficiency states : Organ transplantation, diabetes mellitus, malignancy, treatment with cytotoxic drugs and corticosteroids 4. Currently receiving cytotoxic therapy, or have received it within the last 3 months 5. Pregnancy and lactation. 6. Patients with known symptomatic cardiac disease, such as arrhythmias or coronary artery disease, marked tachypnoea, chronic cor pulmonale, congestive cardiac failure. 7. Patients with hematological abnormalities (WBC less than or equal to 3000/mm3; platelets less than or equal to 100,000/mm3). 8. Seriously ill and moribund patients with complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with Sputum Culture Negative Time to Sputum culture conversion, Number of patients with reduction of bacillary load, Number of patients with improvement or resolution of clinical signs and symptoms, Number of patients with improvement or resolution of chest RX image associated with active TB, Immunogenic properties compared to placebo assessed by cellular populations in ex vivo stimulated peripheral blood mononuclear cellsTimepoint: Month 1, 2 and 6 for DS patients Month 1,2, 6, 12, and 24 for DR patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to Sputum culture conversion, Number of patients with reduction of bacillary load, Number of patients with improvement or resolution of clinical signs and symptoms, Number of patients with improvement or resolution of chest RX image associated with active TB, Immunogenic properties compared to placebo assessed by cellular populations in ex vivo stimulated peripheral blood mononuclear cellsTimepoint: month 1, 2 and 6 for DS patients Month 1,2, 6, 12, and 24 for DR patients | — |
Countries
India
Contacts
Public ContactDr D K Mitra
All India Institute of Medical Sciences
Outcome results
None listed