| CTRI Number |
CTRI/2022/07/044327 [Registered on: 26/07/2022] Trial Registered Prospectively |
| Last Modified On: |
25/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the prevalence, clinical spectrum , renal and electrolyte abnormalities in patient with HIV/AIDS seropositive patients |
|
Scientific Title of Study
|
To study the prevalance , clinical spectrum, renal and electrolyte abnormalities in HIV seropositive patients in a tertiary hospital in Manipal |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajdeb Saha |
| Designation |
Registrar |
| Affiliation |
Kasturba Hospital |
| Address |
Department of nephrology ,
Kasturba hospital ,
Madhav nagar , Manipal
Udupi
Department of nephrology ,
Kasturba hospital ,
Madhav nagar , Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9561409398 |
| Fax |
|
| Email |
rajdeb@live.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajdeb Saha |
| Designation |
registrar |
| Affiliation |
Kasturba hospital |
| Address |
Department of nephrology ,
Kasturba hospital ,
Madhav nagar , Manipal
Udupi
Department of nephrology ,
Kasturba hospital ,
Madhav nagar , Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9561409398 |
| Fax |
|
| Email |
rajdeb@live.com |
|
Details of Contact Person
Public Query
|
| Name |
RAVINDRA PRABHU |
| Designation |
professor and head of unit |
| Affiliation |
kasturba hospital |
| Address |
Department of nephrology ,
Kasturba hospital ,
Madhav nagar , Manipal
Udupi
Department of nephrology ,
Kasturba hospital ,
Madhav nagar , Manipal
Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9561409398 |
| Fax |
|
| Email |
ravindra.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
| RAJDEB SAHA (SELF) |
|
|
Primary Sponsor
|
| Name |
Rajdeb Saha |
| Address |
Department of nephrology ,
kasturba hospital, manipal |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| RAJDEB SAHA |
KASTURBA HOSPITAL |
DEPARTMENT OF NEPHROLOGY , KASTURBA HOSPITAL ,
MADHAV NAGAR , MANIPAL
UDUPI
Udupi
KARNATAKA |
9561409398
rajdeb@live.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| kasturba medical college and kasturba hospital institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, (2) ICD-10 Condition: E83||Disorders of mineral metabolism, (3) ICD-10 Condition: B20||Human immunodeficiency virus [HIV]disease, (4) ICD-10 Condition: E87||Other disorders of fluid, electrolyte and acid-base balance, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients diagnosed as HIV seropositive during the study and who have come for follow up after beginning of study . |
|
| ExclusionCriteria |
| Details |
Lost to follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)study spectrum of renal and electrolytes abnormalities in HIV seropositive patients
|
The patient will be assessed at baseline and 6 months and outcome monitored .
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) progression of eGFR
2)compare mortality between normal renal fucntion HIV seropositive patient with hiv seropostive with renal dysfucntion
3)compare CD4 count with renal dysfunction
|
to study the outcomes at the beginning and at the end of 6 months |
|
|
Target Sample Size
|
Total Sample Size="675"
Sample Size from India="675"
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)
|
30/07/2022 |
| 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="1"
Months="0"
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
|
Human immunodeficiency virus (HIV) infection is a global pandemic with 36.9 million people
. Infected worldwide In India alone, 2.1 million people were estimated to be infected in 2017 with an adult prevalence of 0.2%, leading to 69,000 deaths. India has a low HIV prevalence of
0.22 % By the year 2006, it was estimated that there were around 5.6 million cases of HIV in the
country, concentrated mainly in six states of the country, namely Maharashtra, Andhra Pradesh
(AP), Karnataka, Tamil Nadu, Manipur, and Nagaland. A wider availability and improvement of
combination antiretroviral therapy regiments (cART), AIDS-related deaths and opportunistic
infectious diseases have markedly decreased. The human immunodeficiency virus (HIV) is
classically associated with collapsing focal segmental glomerulosclerosis, direct HIV related
nephropathy can also manifest as HIV-immune-complex kidney disease and thrombotic
microangiopathy. In recent years, with the advent of combination antiretroviral therapy and
effective diffusion of these medications, patients are living longer lives without classic
manifestations of the disease. Currently, disorders associated with nephrotoxicity of certain HIV
therapies appear to be more prevalent, as well as a surge in non-infectious comorbidities, such as
diabetes or hypertension, as aetiologies of nephropathy in people living with HIV
(PLWHIV).Renal disease remains one of the major causes of mortality in HIV infected patients,
with a six-fold increase in mortality for those suffering from acute kidney injury (AKI) and chronic kidney disease (CKD). The spectrum of kidney diseases in HIV patients is quite broad,
ranging from proteinuria, electrolyte losses, and acute kidney injury
(AKI) to various
degrees of chronic kidney disease (CKD). Despite large number of HIV-infected cases in Asian
countries and in India, systematic studies of renal involvement in such patients are lacking.With
this perspective, this study will be carried out to elucidate prevalence, the clinical spectrum and
various renal and electrolyte abnormalities in HIV patients from a tertiary care centre (Manipal) |