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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  
None 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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.

  

 
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