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CTRI Number  CTRI/2025/11/096893 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Study on how HIV disease treatment with Tenofovir, Lamivudine, and Dolutegravir which are drugs given for the treatment of HIV affects kidney function, immune cell count , and blood cholesterol levels. 
Scientific Title of Study   Early Clinico Pharmacological Effects of Tenofovir Lamivudine Dolutegravir regimen on Renal Parameters, CD4 Count, and Lipid Profile in Patients with Human Immunodeficiency Virus Infection. 
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 Abhishek Dass 
Designation  Post Graduate Trainee 
Affiliation  Gajra Raja Medical College, Gwalior 
Address  Gajra Raja Medical College, Department of Pharmacology, Gwalior , M.P

Gwalior
MADHYA PRADESH
474009
India 
Phone  9752801397  
Fax    
Email  abhishek05.das@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajkumar Arya 
Designation  Professor and Head of Department 
Affiliation  Gajra Raja Medical College, Gwalior 
Address  Gajra Raja Medical College, Department of Pharmacology, Gwalior , M.P

Gwalior
MADHYA PRADESH
474009
India 
Phone  9300793791  
Fax    
Email  rajaryagrmc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajkumar Arya 
Designation  Professor and Head of Department 
Affiliation  Gajra Raja Medical College, Gwalior 
Address  Gajra Raja Medical College, Department of Pharmacology, Gwalior , M.P

Gwalior
MADHYA PRADESH
474009
India 
Phone  9300793791  
Fax    
Email  rajaryagrmc@gmail.com  
 
Source of Monetary or Material Support  
Gajra Raja Medical College, Veer Savarkar Marg, Gwalior, Madhya Pradesh, 474009 
 
Primary Sponsor  
Name  Dr Abhishek Dass 
Address  Gajra Raja Medical College Gwalior Madhya Pradesh 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhishek Dass  J.A. Group of Hospitals  Gajra Raja Medical college, J.A. Group of Hospitals Block B HIV Clinic, Department of Medicine
Gwalior
MADHYA PRADESH 		 9752801397

abhishek05.das@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, GAJRA RAJA MEDICAL COLLEGE, GWALIOR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patients with confirmed HIV infection.
2. Initiated on TLD regimen (treatment naïve or switched from other ART) for less than 1 month at enrollment.
3. Willing to provide written informed consent.  
 
ExclusionCriteria 
Details  1. Severe renal impairment at baseline.
2. Pregnant or breastfeeding women.
3. Known hypersensitivity to TLD components.
4. Incomplete baseline data for primary outcomes.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess changes in renal parameters serum creatinine estimated glomerular filtration rate [eGFR]), CD4 count, and lipid profile (total cholesterol [TC], low- density lipoprotein [LDL], high-density lipoprotein [HDL], triglycerides) in HIV patients on TLD from baseline to 3rd and 6th month.  baseline which is at 0 months
3rd month
6th month 
 
Secondary Outcome  
Outcome  TimePoints 
To assess changes in renal parameters serum creatinine estimated glomerular filtration rate eGFR, CD4 count & lipid profile total cholesterol , low- density lipoprotein high-density lipoprotein triglycerides in HIV patients on TLD from baseline to 3rd & 6th month.  at 6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/12/2025 
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 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   Evaluating the early clinico pharmacological effects of the TLD regimen is important because it helps identify how quickly and safely patients respond to this first-line antiretroviral therapy. Early monitoring of renal parameters, CD4 count, and lipid profile provides insight into the drug’s tolerability, efficacy, and safety. Since tenofovir can affect kidney function and dolutegravir may influence lipid metabolism, early detection of any adverse changes allows timely intervention to prevent long-term complications. Moreover, tracking CD4 count improvements helps assess immune recovery and overall treatment effectiveness, ensuring optimal patient outcomes and adherence. 
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