| CTRI Number |
CTRI/2024/11/076844 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Viral drug resistance for HIV medicines |
|
Scientific Title of Study
|
Anti-retroviral susceptibility and resistance pattern among people living with HIV |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshay S |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeswari Medical College and Hospital |
| Address |
Department of Dermatology RRMCH
No 202 MYSORE ROAD KAMBIPURA KENGERI KARNATAKA
Bangalore
KARNATAKA
560074
India |
| Phone |
9480526226 |
| Fax |
|
| Email |
dr.samagani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akshay S |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeswari Medical College and Hospital |
| Address |
Department of Dermatology RRMCH
No 202 MYSORE ROAD KAMBIPURA KENGERI KARNATAKA
KARNATAKA
560074
India |
| Phone |
9480526226 |
| Fax |
|
| Email |
dr.samagani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Akshay S |
| Designation |
Assistant Professor |
| Affiliation |
Rajarajeswari Medical College and Hospital |
| Address |
Department of Dermatology RRMCH
No 202 MYSORE ROAD KAMBIPURA KENGERI KARNATAKA
KARNATAKA
560074
India |
| Phone |
9480526226 |
| Fax |
|
| Email |
dr.samagani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajrajeswari Medical College and Hospital
No 202 Kambipura Kengeri , Bangalore Karnataka India 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Akshay S |
| Address |
No 202 MYSORE ROAD KAMBIPURA KENGERI KARNATAKA 560074 |
| 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 |
| Dr Akshay S |
RajaRajeswari Hospital |
Room no 1198 Department of Dermatology
202 Kambipura Mysore Road Bangalore-560 074
Bangalore
KARNATAKA |
9480526226
dr.samagani@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 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All HIV positive /People living with HIV(PLHIV), aged above 18 years
Treatment naïve patients or on antiretroviral therapy (ART)
|
|
| ExclusionCriteria |
| Details |
• PLHIV with known resistance of any particular group of drugs
PLHIV with viral load is below the lower limits of detection (undetectable)
PLHIV on alternative medicines
PLHIV not willing to participate in the study
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| RESISTANCE PATTERN ANALYSIS |
Baseline, Week 4, Week 8 and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjects retracting consent |
Baseline Week 4 Week 8 & Week 12 |
|
|
Target Sample Size
|
Total Sample Size="107"
Sample Size from India="107"
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)
|
02/12/2024 |
| 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 Yet Recruiting |
| 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
|
HIV/ AIDS is considered to be an important public health issue in the era of resistance. We are conducting a cross-sectional study to determine antiviral drug susceptibility and drug resistance pattern in HIV positive individuals. After obtaining ethical committee clearance, consenting 107 subjects passing inclusion and exclusion criteria will be allocated. A blood sample of 10 ml will we obtained with all biohazard practices and will be analyzed by PCR, Genotyping and other relevant tests. Finally resistance pattern to each group of drugs will be tabulated and reported. This analysis will help in detection and further selection of combination of antiretroviral drugs to be used in future. This study is of public health importance. |