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CTRI Number  CTRI/2024/04/065522 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 29/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Benefits and safety of major medicines in HIV patients. 
Scientific Title of Study   Study of the efficacy and safety of Dolutegravir based first line anti-retroviral Therapy in people living with HIV infection. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amol Prakash Dehade 
Designation  Junior resident 
Affiliation  Institute of Medical Sciences, B.H.U. 
Address  Department of Pharmacology, IMS, BHU, Aurobindo Colony, Banaras Hindu University Campus, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8369236151  
Fax    
Email  amole.dehade.ad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ved Prakash 
Designation  Assistant Professor 
Affiliation  Institute of Medical Sciences, B.H.U. 
Address  Department of Pharmacology, IMS, BHU, Aurobindo Colony, Banaras Hindu University Campus, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8601741409  
Fax    
Email  sonivedgmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ved Prakash 
Designation  Assistant Professor 
Affiliation  Institute of Medical Sciences, B.H.U. 
Address  Department of Pharmacology, IMS, BHU, Aurobindo Colony, Banaras Hindu University Campus, Varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  8601741409  
Fax    
Email  sonivedgmc@gmail.com  
 
Source of Monetary or Material Support  
Institute of Medical Sciences, Banaras Hindu University 
 
Primary Sponsor  
Name  Institute of Medical Sciences, Banaras Hindu University 
Address  Aurobindo Colony, Banaras Hindu University Campus, Varanasi 
Type of Sponsor  Government medical college 
 
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 
Dr Amol Prakash Dehade  Sir Sunderlal Hospital, IMS, BHU  room 125, shushruta building, near trauma centre, banaras hindu university
Varanasi
UTTAR PRADESH 		 8369236151

amole.dehade.ad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Institute of Medical Sciences, Banaras Hindu University   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Minimum 1000 patients for retrospective and prospective studies with confirmed and documented HIV1 infection on Dolutegravir, Lamivudine and Tenofovir Alafenamide 
 
ExclusionCriteria 
Details  Patients on 2nd, 3rd, other regimens and patients not giving consent to the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine whether a statistically significant reduction in viral load and a statistically significant increase in CD4 cell count happens when compared with the previous regimen  Both viral load and CD4 count measured at 6 and 12 months after starting the regimen 
 
Secondary Outcome  
Outcome  TimePoints 
To determine statistically significant adverse events once the treatment is started   Follow up at 6 months & 1 year 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   01/05/2024 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sonivedgmc@gmail.com].

  6. For how long will this data be available start date provided 08-08-2024 and end date provided 31-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study will be a single center, open label, retrospective as well as prospective cohort study. Total sample size is 1000. after obtaining the written and informed consent from the patient, Detailed history shall be taken from the subjects to see the signs and symptoms of other opportunistic infections, MTB, Diabetes Mellitus, Hypertension, Lipodystrophy, HBV, HCV infection. Patients shall be followed up regularly at the ART center. Adherence, side effects body weight shall be documented. Viral and CD4 shall be documented at 6 and 12 monthly.  
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