| CTRI Number |
CTRI/2018/03/012576 [Registered on: 15/03/2018] Trial Registered Prospectively |
| Last Modified On: |
07/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effects of newly marketed antiretroviral drug, Tab. Dolutegravir 50 mg, when given along with other Antiretroviral drugs in HIV1 positive individuals |
|
Scientific Title of Study
|
Multicenter, non-randomized, non-controlled, open-label Phase IV trial to evaluate the safety, tolerability and effectiveness of Dolutegravir 50 mg tablet of Emcure Pharmaceuticals along with other antiretrovirals among HIV-1 infected subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhijit Vasantrao Kadam |
| Designation |
Scientist B |
| Affiliation |
ICMR-National AIDS Research Institute |
| Address |
ICMR-National AIDS Research Institute, 73 G Block, MIDC, Bhosari
73 G BLOCK, MIDC, BHOSARI, PUNE 411026
Pune
MAHARASHTRA
411026
India |
| Phone |
02027331200 |
| Fax |
27121071 |
| Email |
akadam@nariindia.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit Vasantrao Kadam |
| Designation |
Scientist B |
| Affiliation |
ICMR-National AIDS Research Institute |
| Address |
ICMR-National AIDS Research Institute, 73 G Block, MIDC, Bhosari
73 G Block, MIDC, Bhosari
Pune
MAHARASHTRA
411026
India |
| Phone |
02027331200 |
| Fax |
27121071 |
| Email |
akadam@nariindia.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijit Vasantrao Kadam |
| Designation |
Scientist B |
| Affiliation |
ICMR-National AIDS Research Institute |
| Address |
ICMR-National AIDS Research Institute, 73 G Block, MIDC, Bhosari
73 G Block, MIDC, Bhosari
Pune
MAHARASHTRA
411026
India |
| Phone |
02027331200 |
| Fax |
27121071 |
| Email |
akadam@nariindia.org |
|
|
Source of Monetary or Material Support
|
| Emcure Pharmaceuticals Ltd.
Plot No P2, ITBT Park, MIDC, Phase II,
Hinjwadi, Pune 411057, India
Tel 91-20-39821300 Fax 91-20-39821340
|
|
|
Primary Sponsor
|
| Name |
Emcure Pharmaceuticals Ltd |
| Address |
Plot No. P2, ITBT Park, MIDC, Phase II,
Hinjwadi, Pune 411057
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Kumarasamy |
Chennai Antiviral Research & Treatment Clinical Research site of NIH Voluntary Health Services |
Taramani, Chennai, India 600113
Chennai
TAMIL NADU |
9176912007
kumarsamy@cartcrs.org |
| Dr Sanjay Pujari |
Institute Of Infectious Diseases |
Director, D Wing, Kumar Business Court, Mukund Nagar, Pune - 411037
Pune
MAHARASHTRA |
020-24274950
sanjaypujari@gmail.com |
| Dr Abhimanyu Makane |
Ishwar Institute of Healthcare |
Ishwar heights, Plot.No 7, Gut.No 6/1, Jaisinghpura, Near Punjabi Bhawan, Mumbai-Nashik Highway road, Padegaon, Aurangabad – 431002, Maharashtra, India.
Aurangabad
MAHARASHTRA |
9822314268
abhimanyu.makane@gmail.com |
| Dr Milind Bhrushundi |
Lata Mangeshkar Hospital |
Department of Medicine, YMCA Complex, Maharajbagh Road
Sitabuldi Nagpur 440001
Nagpur
MAHARASHTRA |
9860562640
bmili@yahoo.com |
| Dr Vinay Kulkarni |
Prayas Amrita Clinic |
Coordinator, Prayas Health Group and Chief Clinician at Prayas Amrita Clinic , Karve Road Corner, Sambhaji Bridge, Deccan Gymkhana, Pune, Maharashtra 411004
Pune
MAHARASHTRA |
25420337
vinay@prayaspune.org |
| Dr Narendra Singh |
Shija Hospitals and Research Institute Pvt. Ltd. |
Health City, Langol Imphal West
Imphal West
MANIPUR |
9436026870
narenpot@gmail.com |
| Dr Ishwar Gilada |
Unison Medicare and Research Centre |
Maharukh Mansion, Alibhai Premji Marg, Grant Road (E), Mumbai - 400007
Mumbai
MAHARASHTRA |
91-22-23061616
gilada@usa.net |
| Dr Pradeep Amrose |
YRG Care Medical Centre |
Y. R. Gaitonde Centre for AIDS Research and Education, Chief Medical Officer, old.no 15, new No 34, East street, Kilpauk garden colony, Chennai,Tamil Nadu
INDIA. 600 010
Chennai
TAMIL NADU |
9884093784
pradeep@yrgcare.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shija Hospital Langol,Imphal |
Approved |
| Ishwar Hospital Ethics Committee |
Approved |
| NKP Salve Institute for medical Sciences and Research centre and Lata Mangeshkar Hospital, Digdoh Hill, Hingna Road, Nagpur 440019 |
Approved |
| Prayas, Amrita clinic, Athawale Corner building, Near Panchaleshvar mandir, Karve Road corner, Deccan Gymkhana, Pune 411004 |
Approved |
| Rao Nursing Home Survey no 691 A-1A-1, CTB No 1897-B, Pune Satara Road, Bibwewadi, Pune 411037 |
Approved |
| Unison Medicare And Research Centre Ethics Committee |
Approved |
| VHS Hospital Institutional Ethics Committee |
Approved |
| YRGCARE Medical Centre, VHS Hospital, Rajiv Salai, Taramani, Chennai 600113 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
| Status |
| No Objection Certificate |
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
HIV 1 INFECTION, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Tab. Dolutegravir 50 mg |
Integrase Inhibitor |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
79.00 Year(s) |
| Gender |
Both |
| Details |
HIV 1 infected Subjects
Willing and able to understand and provide signed and dated written informed consent after screening.
18 years or older, and adults with weight more than 40 kgs.
HIV-1 positive Subjects who are either.
ART naïve
Treatment experienced with NRTI’s, NNRTI’s , PI and Raltegravir based regimen with Viral load less than 50 copies/ml
Subjects with ART failure having Viral load more than 50 copies/ml
General medical condition does not interfere with trial procedures
Females are eligible if:
They do not plan to become pregnant during the study and next 18 months after baseline
Negative screening pregnancy test and uses one of the following methods:
Abstinence from penile/vaginal intercourse during the study
Double contraceptive methods of which one must be barrier (condom).
|
|
| ExclusionCriteria |
| Details |
Known hypersensitivity to any of the Anti-retrovirals drugs or components of Dolutegravir based regimen.
Pulmonary tuberculosis and or Extrapulmonary tuberculosis on treatment.
Creatinine clearance less than 30mL per min determined using Cockcroft and Gault formula.
Hepatic impairment of Child Pugh B C.
Treatment with Radiation therapy, cancer chemotherapy or immunomodulator within 28 days of Screening.
Any preexisting psychiatric conditions: depression, bipolar disorders, schizophrenia.
Pregnant and Lactating HIV-1 infected subjects.
Unwilling to give consent for audio recording and unwilling to participate in the study.
Any other Contraindications of the other antiretroviral drugs to be used as backbone therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety
Incidence rate of AE_ADVERSE EVENTS_ by system organ class and severity
Frequency and severity of AE_ Clinical and Lab abnormalities
Intention to treat analysis
Tolerability
Number of subjects who discontinue the study treatment due to AE
Assessed by comparing AE profile among subjects given twice daily vs single dose of dolutegravir and among those with advanced immunosuppression
Analysis of time to discontinuation of antiretroviral regimen due to any AE
|
Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria.
Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
effectiveness as measured trends in change of viral load
|
12 and 24 |
|
|
Target Sample Size
|
Total Sample Size="275"
Sample Size from India="275"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
18/03/2018 |
| 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="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The primary purpose of this phase 4 study is to assess the safety and tolerability of Tab. Dolutegravir 50mg in HIV 1 infected individuals who are either ART naïve or on treatment with viral load less than 50 copies/ml or ART failure with viral load more than 50 copies/ml. This study would be multicentric , non randomized and open label trial with a aim to recruit 275 patients as per DCGI recommendation. We would calculate the incidence rates of adverse events ,lab abnormalities and do causality assessment using WHO UMC scale and NARANJO SCALE. The participants would be evaluated with neuropsychiatric symptom questionnaire during the baseline and during next 4 visits in the six months follow up of the study. |