| CTRI Number |
CTRI/2024/04/065792 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of multiple medicines in elderly HIV positive people and their effects on quality of life and compliance to treatment. |
|
Scientific Title of Study
|
Assessment of polypharmacy among aged people living with HIV and its impact on quality of life and adherence to anti-retroviral therapy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RASHMI MEENA |
| Designation |
Doctor (Post graduate resident) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of medicine, first floor,BL Taneja Block,Maulana Azad Medical College and Lok Nayak Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
8005700599 |
| Fax |
|
| Email |
Rashmimeena71@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Anuradha |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of medicine, first floor,BL Taneja Block,Maulana Azad Medical College and Lok Nayak Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
9643136268 |
| Fax |
|
| Email |
drsanuradha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Anuradha |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of medicine, first floor,BL Taneja Block,Maulana Azad Medical College and Lok Nayak Hospital, New Delhi
Central
DELHI
110002
India |
| Phone |
9643136268 |
| Fax |
|
| Email |
drsanuradha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of medicine,BL Taneja block,maulana azad medical college and lok nayak hospital,New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of medicine, first floor,BL Taneja Block,Maulana Azad Medical College and Lok Nayak Hospital |
| 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 Rashmi meena |
Maulana azad medical college and lok nayak hospital |
Room no 618 ART centre,opd block,lok nayak hospital
Central
DELHI |
8005700599
Rashmimeena71@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad 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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Confirmed HIV infection (as per NACO guidelines).
2.Age 50 years or more (UNAIDS definition of aged PLHIV).
3.Subjects on ART for atleast 1 year. |
|
| ExclusionCriteria |
| Details |
Subjects with any serious medical condition, like neurological disease that prevents the Subjects answering the questionnaires. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of polypharmacy among aged PLHIV. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Potential drug-drug interactions due to polypharmacy.
2.Effect of polypharmacy on the quality of life and anti-retroviral treatment adherence. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
29/04/2024 |
| 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
|
Polypharmacy is a growing concern among older PLHIV, because of adverse drug reactions, drug-drug interactions, reduced adherence to ART. Polypharmacy has been commonly reported in PLHIV and its prevalence varies from 15% to 55% in different studies. Polypharmacy can lead to harmful drug-drug interactions and have a significant impact on adherence to ART. Polypharmacy can lead to poor health outcomes, and worse quality of life in older PLHIV. There are limited systematic studies on the prevalence of polypharmacy among PLHIV from India and this study will assess the prevalence of polypharmacy among aged PLHIV and their impact on quality of life and ART adherence. |