| CTRI Number |
CTRI/2017/08/009437 [Registered on: 21/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of Kala-azar, Leprosy verses tuberculosis infectios among HIV Patients |
|
Scientific Title of Study
|
Study of Prevalence of neglected tropical diseases; leprosy and Visceral leishmaniasis verses tuberculosis co infections among HIV patients |
| Trial Acronym |
NTD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjan Kumar Singh |
| Designation |
Physician |
| Affiliation |
ART centre, Sadar Hospital |
| Address |
ART centre, Sadar Hospital Khagaria.
Khagaria BIHAR 851204 India |
| Phone |
|
| Fax |
|
| Email |
dr_ranjankumarsingh@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Ranjan Kumar Singh |
| Designation |
Physician |
| Affiliation |
ART centre, Sadar Hospital |
| Address |
Nodal Officer, ART centre, Sadar Hospital Khagaria.
Khagaria BIHAR 851204 India |
| Phone |
06244223106 |
| Fax |
|
| Email |
dr_ranjankumarsingh@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Ranjan Kumar Singh |
| Designation |
Physician |
| Affiliation |
ART centre, Sadar Hospital |
| Address |
Nodal Officer, ART centre, Sadar Hospital Khagaria.
Khagaria BIHAR 851204 India |
| Phone |
6244223106 |
| Fax |
|
| Email |
dr_ranjankumarsingh@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ART centre |
| Address |
Nodal officer ART centre Sadar Hospital Khagaria-851204 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Ranjan Kumar Singh |
Sadar Hospital |
ART center, 2nd floor, Khagaria BIHAR |
6244223106
dr_ranjankumarsingh@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ART centre Ethics committee, Khagaria |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. all the patients between age 6 to 60 would be included in the study. |
|
| ExclusionCriteria |
| Details |
1. Lost to follow up {LFU}
2. Death during study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of NTD, and Tb. co infectons among HIV patients enrolled from Jan 2016 to June 2017. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CD4 cell count among NTD co infections and Tb. co infections and their comparative statistical analysis |
16 months |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="412" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2016 |
| Date of Study Completion (India) |
28/04/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
www.japi.org/may_2018/24_Correspondence |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Background: HIV positive patients also suffer from neglected tropical diseases (NTDs). There is geographical overlap of neglected tropical diseases and HIV/AIDS, and the frequent occurrence of these disorders call for an integrated approach for their control. A new agenda, on accelerating progress on HIV, tuberculosis, malaria, hepatitis and neglected tropical diseases, has been set for 2016-2030. India accounts for 40% of world’s neglected diseases. For example, there is approximately 200,000–400,000 new cases of visceral leishmaniasis (VL) occurring annually worldwide 2014; over 90% of VL occur in six countries, namely Bangladesh, Brazil, Ethiopia, India, South Sudan, and Sudan. Prevalence of neglected tropical diseases, like Leprosy, and visceral leishmaniasis co infections among HIV patients is to be determined and compared with HIV/tuberculosis co infections. Aims and objectives: 1. Estimation of prevalence of neglected tropical diseases (Leprosy, visceral leishmaniasis) co infections in comparison to prevalence of tuberculosis co infections among HIV patients. 2. Determination of status of CD4 T cell count among patients of HIV with neglected tropical diseases and with tuberculosis. Methods: It is an observational study (retrospective), would be done on the HIV positive patients attending ART centre from January’ 2016 to April’ 2017. All patients were subjected to screening for leprosy. VL, and tuberculosis. Diagnosis for leprosy, VL, and tuberculosis co infections were established by skin slit or skin smear examination, ElISA for kala azar with RK-39, and sputum examination by microscopy and NAAT respectively. Their CD4 cells, estimated during screening examination, would be assessed. Prevalence of neglected tropical co infections and tuberculosis infections would be compared; their CD4 cell count would be compared. |