| CTRI Number |
CTRI/2025/07/091910 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on the Safety and Effectiveness of Tenofovir, Lamivudine, and Dolutegravir (TLD) Treatment in Newly Diagnosed HIV Patients |
|
Scientific Title of Study
|
TO STUDY THE EFFICACY AND SAFETY OF THE TENOFOVIR, LAMIVUDINE & DOLUTEGRAVIR (TLD) REGIMEN BY ASSESSING HEMATOLOGICAL AND BIOCHEMICAL PARAMETERS IN NEWLY DIAGNOSED HIV PATIENTS: A PROSPECTIVE OBSERVATIONAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr GAJENDRA G |
| Designation |
POST GRADUATE, DEPARTMENT OF PHARMACOLOGY |
| Affiliation |
Shri Atal Bihari Vajpayee Medical College and Research Institute |
| Address |
1, Lady Curzon Rd, Shivaji Nagar, Bengaluru
Bangalore
KARNATAKA
560001
India |
| Phone |
9611523671 |
| Fax |
|
| Email |
gaju2589@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NAGESH H N |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OF PHARMACOLOGY |
| Affiliation |
Shri Atal Bihari Vajpayee Medical College and Research Institute |
| Address |
1, Lady Curzon Rd, Shivaji Nagar, Bengaluru
Bangalore
KARNATAKA
560001
India |
| Phone |
9972279046 |
| Fax |
|
| Email |
nagu728@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr GAJENDRA G |
| Designation |
POST GRADUATE, DEPARTMENT OF PHARMACOLOGY |
| Affiliation |
Shri Atal Bihari Vajpayee Medical College and Research Institute |
| Address |
1, Lady Curzon Rd, Shivaji Nagar, Bengaluru
Bangalore
KARNATAKA
560001
India |
| Phone |
9611523671 |
| Fax |
|
| Email |
gaju2589@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shri Atal Bihari Vajpayee Medical College and Research Institute |
| Address |
1 Lady Curzon Rd Shivaji Nagar Bengaluru Karnataka 560001 |
| 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 GAJENDRA G |
ART CENTER, Bowring and Lady Curzon Hospital |
1, Lady Curzon Rd, Shivaji Nagar, Bengaluru
Bangalore
KARNATAKA |
9611523671
gaju2589@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE OF SHRI ATAL BIHARI VAJPAYEE MEDICAL COLLEGE & RESEARCH INSTITUTE |
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 |
99.00 Year(s) |
| Gender |
Both |
| Details |
1.Newly diagnosed HIV patients aged more than 18 years initiated on TLD therapy
2.Patients providing informed consent for participation. |
|
| ExclusionCriteria |
| Details |
1. Patients with abnormal Liver function tests, Renal function tests, Lipid profiles and all types of Anaemia (IDA, Megaloblastic anaemia etc.) which may have confounding factors that affect the interpretation of Hematological and Biochemical parameters
2. Pregnant or lactating women.
3. Patients diagnosed with any co-morbid conditions such as diabetes mellitus, hypertension, tuberculosis, hepatitis B or C, chronic kidney disease, or any other condition.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in hematological and biochemical parameters over time in newly diagnosed HIV patients receiving TLD regimen. |
1. At Baseline
2. At 3 months
3. At 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
11/08/2025 |
| 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="6"
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 aims to evaluate the efficacy and safety of the Tenofovir, Lamivudine, and Dolutegravir (TLD) regimen in newly diagnosed HIV patients. It is a prospective observational study conducted at the ART centre of Bowring and Lady Curzon Hospital, Bangalore. The study will assess changes in hematological and biochemical parameters such as hemoglobin, liver enzymes, renal markers, and lipid profile at baseline, 3 months, and 6 months of TLD therapy. A total of 190 participants will be enrolled and monitored for drug adherence and adverse drug reactions. The goal is to generate region-specific data on the safety and treatment outcomes of the TLD regimen in the Indian population. |