| CTRI Number |
CTRI/2018/12/016519 [Registered on: 03/12/2018] Trial Registered Prospectively |
| Last Modified On: |
06/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross-sectional study with cohort study of a sub-group of the study population |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence and characteristics of tuberculosis in people living with HIV |
|
Scientific Title of Study
|
A study on the prevalence and characteristics of tuberculosis in people living with HIV in a tertiary care hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragadeesh T |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine,
Kasturba Hospitals,
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9788851601 |
| Fax |
|
| Email |
sapnet94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kavitha Saravu |
| Designation |
Professor and Chief |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine,
Kasturba Hospitals,
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9448107636 |
| Fax |
|
| Email |
kavithasaravu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Pragadeesh T |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Department of General Medicine,
Kasturba Hospitals,
Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9788851601 |
| Fax |
|
| Email |
sapnet94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Medicine,
Kasturba Hospital,
Manipal |
|
|
Primary Sponsor
|
| Name |
Kasturba Hospitals |
| Address |
Kasturba Hospitals, Madhav Nagar, Manipal, 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr T Pragadeesh |
Kasturba Hospital |
Department of General Medicine,
Kasturba Hospital,
Manipal Udupi KARNATAKA |
9788851601
sapnet94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, (2) ICD-10 Condition: A15-A19||Tuberculosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients who are either newly diagnosed with HIV or previously diagnosed people living with HIV, under the care of Kasturba Hospitals |
|
| ExclusionCriteria |
| Details |
All pediatric HIV patients; any patient fulfilling the inclusion criteria, but who do not have CD4 counts tested in the last 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of tuberculosis in PL-HIV |
At the time of seeing the patient (day 0) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Practice of Isoniazid Prophylactic Therapy in PL-HIV |
0, 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="249" Sample Size from India="249"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="10" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Tuberculosis is the most common opportunistic infection and the most common cause of mortality in PL-HIV. This is a study targeting this co-epidemic, with the objective of assessing the prevalence and characteristics of tuberculosis in PL-HIV, stratified by their CD-4 count, presenting to a tertiary care hospital. Informed consent will be obtained from both newly diagnosed and previously diagnosed people living with HIV under the care of the Department of General Medicine, and will be recruited under the study based on the inclusion and exclusion criteria Data will be collected on the socio-demographic, clinical and laboratory characteristics of the patients, using a structured proforma. Past history of tuberculosis will also be recorded. The test records captured to ascertain tuberculosis are a part of the standard of care. No additional tests will be done as a part of the study. The data collected will be analysed and the prevalence and characteristics of tuberculosis will be measured and stratified based on CD4 count status of the patient. As a second objective, the practice of Isoniazid prophylactic therapy in people living with HIV and its outcomes is also being studied. The study participants who are on IPT (started as a part of the standard of care) will be followed up to assess the outcome of the same, for a duration of 6 months. |