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Understanding Side Effects and Medicine Response in People Taking Treatment for Tuberculosis (TB) and HIV Together

Anti-Tuberculosis and Anti-Retroviral Therapy in the TB HIV Syndemic: Pharmacogenetic and Population Pharmacokinetic Predictors of Adverse Drug Reactions - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/111621
Enrollment
560
Registered
2026-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: A150- Tuberculosis of lung Health Condition 2: A154- Tuberculosis of intrathoracic lymph nodes Health Condition 3: A155- Tuberculosis of larynx, trachea and bronchus Health Condition 4: A156- Tuberculous pleurisy Health Condition 5: A157- Primary respiratory tuberculosis Health Condition 6: A158- Other respiratory tuberculosis Health Condition 7: A159- Respiratory tuberculosis unspecified Health Condition 8: A170- Tuberculous meningitis Health Condition 9: A171- Meningeal tub

Interventions

Intervention1: Nil: Nil

Sponsors

Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education (MAHE), Manipal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients who are 18 years and above. 2. Patients with a confirmed tuberculosis diagnosis (Pulmonary or extrapulmonary), confirmed HIV diagnosis with or without comorbidities. 3. Patients planned for first-line anti-tubercular drug (Isoniazid, Rifampicin, Ethambutol, Pyrazinamide) with anti-retroviral therapy (ART) (Dolutegravir-based ART regimen and other ART regimen) and other co-medications. 4. Patients who are willing to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with advanced liver or renal disease (estimated Glomerular Filtration Rate less than 30ml per min). 2. Clinically unstable patients.

Design outcomes

Primary

MeasureTime frame
Association of pharmacogenetic variants with ADR risk. Pharmacokinetic parameters of study drugs (CL/F, Ka). Timepoint: Genotyping will be performed at baseline. Outcomes, including the occurrence of adverse drug reactions (ADRs), will be assessed at baseline, 4 weeks, and 8 weeks after treatment initiation. Patients will also be monitored at week 2 and whenever clinically indicated to facilitate early detection and documentation of ADRs associated with genetic variability in drug response.—

Secondary

MeasureTime frame
Impact of ATT ART drug-drug interactions on drug exposure & toxicity Risk-prediction model integrating pharmacogenomics, DDIs, Pop-PK TB outcomes (sputum conversion, cure, relapse) HIV outcomes (viral load suppression, CD4 change) Timepoint: 3 years—

Countries

India

Contacts

Public ContactAkhil Arun

Manipal College of Pharmaceutical Sciences, MAHE, Manipal

mahadev.rao@manipal.edu8105706060

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026