| CTRI Number |
CTRI/2022/09/045278 [Registered on: 07/09/2022] Trial Registered Prospectively |
| Last Modified On: |
06/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study of renal adverse effects of Tenofovir in HIV infected children on ART |
|
Scientific Title of Study
|
Study of Renal Adverse Effects of Tenofovir Containing Regimen in HIV Infected Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Kumar |
| Designation |
junior Resident M D Pediatrics |
| Affiliation |
Moti Lal Nehru Medical College |
| Address |
Sarojini Naidu Children Hospital, Church Lane, Tagore Town, Prayagraj, Uttar Pradesh, Moti Lal Nehru Medical College, Prayagraj,
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
8953644978 |
| Fax |
|
| Email |
rk9991818@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Mukesh Vir Singh |
| Designation |
Professor and Head of Department Of Pediatric |
| Affiliation |
Moti Lal Nehru Medical College |
| Address |
Sarojini Naidu Children Hospital, Church Lane, Tagore Town, Prayagraj, Uttar Pradesh, Moti Lal Nehru Medical College, Prayagraj
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
9456630304 |
| Fax |
|
| Email |
mukeshvirsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Kumar |
| Designation |
junior Resident M D Pediatrics |
| Affiliation |
Moti Lal Nehru Medical College |
| Address |
Sarojini Naidu Children Hospital, Church Lane, Tagore Town, Prayagraj, Uttar Pradesh, Moti Lal Nehru Medical College, Prayagraj,
Allahabad
UTTAR PRADESH
211002
India |
| Phone |
8953644978 |
| Fax |
|
| Email |
rk9991818@gmail.com |
|
|
Source of Monetary or Material Support
|
| Moti Lal Nehru Medical College George Town Prayagraj Uttar Pradesh 211002 |
|
|
Primary Sponsor
|
| Name |
Moti Lal Nehru Medical College |
| Address |
Prayagraj Uttar Pradesh |
| 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 Ravindra Kumar |
ART centre |
Pediatric devision, room no 1/40 ART
Allahabad
UTTAR PRADESH |
8953644978
rk9991818@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE MLN MEDICAL COLLEGE and associated HOSPITALS |
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 |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
21.00 Year(s) |
| Gender |
Both |
| Details |
1.All HIV infected children from age 10 years or weight more than 30 kg to 21 years of age receiving Tenofovir containing ART for at least 6 months
2.eGFR more than 60 ml/min/m2
3.Individuals whose base line parameters available before starting ART treatment |
|
| ExclusionCriteria |
| Details |
1.History of Hypertension, Diabetes Mellitus, Congenital Heart disease, Chronic liver failure, Cardio Vascular Disease, Nephrotic syndrome.
2.Hepatitis B and C infection.
3.Transfer of care to other medical care facilities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Changes of eGFR from base line
2.Changes of serum creatinine from base line
3.Changes in creatinine clearance from base line |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes of CD4 count from base line
2.Changes of Serum phosphate during treatment
3.Proteinuria during treatment |
3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2022 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study enrolled HIV infected children aged from 10 to 21 years or weighing more than 30kg, receiving tenofovir containing regimens for at least 6 months at ART Centre, It is a single Centre observational analytical cross sectional study based on renal function parameters by serum and urine analysis. This study will improve the overall management of HIV infected children and help in improving the quality of life in these children. Inclusion criteria- 1. All HIV infected children from age 10 years or weight more than 30 kg to 21 years of age receiving tenofovir containing ART for at least 6 months 2. eGFR more than 60 ml/min/m2 at enrolment 3. Individuals whose base line parameters available before starting treatment Exclusion criteria- 1. History of hypertension, diabetes mellitus, congenital heart disease, chronic liver failure, cardiovascular disease, nephrotic syndrome 2. Hepatitis B and C infection 3. Transfer of care to the other medical care facilities Laboratory parameters- CD4 count, serum creatinine, serum protein, serum phosphate, serum uric acid, serum potassium, RBS, urinary protein, urinary glucose will be measured and eGFR, creatinine clearance will be calculated |