| CTRI Number |
CTRI/2024/08/072710 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
21/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Efficiency of dolutegravir in treatment of HIV infected children |
|
Scientific Title of Study
|
Efficacy of dolutegravir based antiretroviral regimen in HIV positive children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijaya lakshmi Minumanuri |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
110002
India
Central
DELHI
110002
India |
| Phone |
7730865999 |
| Fax |
|
| Email |
vijaya98494@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak Kumar |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
110002
India
Central
DELHI
110002
India |
| Phone |
9211377848 |
| Fax |
|
| Email |
deepakk70@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak kumar |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Paediatrics
Maulana Azad Medical College and associated Lok Nayak Hospital
New Delhi
110002
India
Central
DELHI
110002
India |
| Phone |
9211377848 |
| Fax |
|
| Email |
deepakk70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Paediatrics, Maulana Azad Medical College, Delhi, India, PIN: 110002 |
|
|
Primary Sponsor
|
| Name |
Department of Paediatrics |
| Address |
Maulana Azad Medical College, New Delhi, India, PIN: 110002 |
| Type of Sponsor |
Government 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 Vijaya Lakshmi Minumanuri |
Lok Nayak Hospital |
ART clinic, OPD 6th floor, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi, India, PIN:110002.
New Delhi
DELHI |
7730865999
vijaya98494@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Patients substituted to Dolutegravir based regimen from older treatment regimens.
Newly diagnosed HIV positive children started on DTG regimen. |
|
| ExclusionCriteria |
| Details |
Coinfection with Tuberculosis, Hepatitis B and Hepatitis C.
Patients with chronic liver disease and auto immune diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients having viral suppression after 6 months of treatment with Dolutegravir based regimen. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Proportion of patients having adverse events (if any) following treatment with dolutegravir based regimen and grading of severity of adverse events.
2. Proportion of patients adherent to treatment with Dolutegravir based regimen. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
24/09/2024 |
| 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 - NO
|
|
Brief Summary
|
This study is an observational study aimed at finding the efficacy of Dolutegravir based antiretroviral regimen in HIV positive children aged between 1 month to 15 years. Study will be conducted in Paediatric HIV clinic, Maulana Azad Medical College and associated Lok Nayak Hospital, Delhi. Primary outcome of the study will be the proportion of patients having viral suppression after 6 months of treatment with Dolutegravir based regimen. Secondary outcomes of the study will be: 1. Proportion of patients having adverse events (if any) following treatment with Dolutegravir based regimen and grading of the severity of adverse events. 2. Proportion of patients adherent to treatment with Dolutegravir based regimen. |