| CTRI Number |
CTRI/2018/01/011169 [Registered on: 05/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Adverse drug reactions, drug-drug Interactions and medication adherence outcomes among elderly HIV seropositive patients in comparison with young HIV seropositive patients undergoing highly active antiretroviral therapy. |
|
Scientific Title of Study
|
Assessment of adverse drug reactions, drug-drug interactions and medication
adherence outcomes among elderly HIV seropositive patients in comparison with young HIV
seropositive patients undergoing highly active antiretroviral therapy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanju Rajan |
| Designation |
Student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice,
Manipal College of Pharmaceutical Sciences, MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7795122133 |
| Fax |
|
| Email |
sanjurajan9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhakrishnan Rajesh |
| Designation |
Assistant Professor - Selection Grade |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice,
Manipal College of Pharmaceutical Sciences, MAHE
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
91-820-2922403 |
| Fax |
|
| Email |
rajesh.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sanju Rajan |
| Designation |
Student |
| Affiliation |
Manipal College of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice,
Manipal College of Pharmaceutical Sciences, MAHE
Manipal
KARNATAKA
576104
India |
| Phone |
7795122133 |
| Fax |
|
| Email |
sanjurajan9@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba medical college Kasturba Hospital |
| Address |
Kasturba Medical
College,Manipal,Udupi,Karnataka-576104 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sanju Rajan |
Kasturba Hospital |
Kasturba Hospital, Manipal-
576104, Udupi, KARNATAKA
Udupi
KARNATAKA |
7795122133
sanjurajan9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
HIV seropositive patients , |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
HIV seropositive patients (HIV-SPP) patients above 18 years of age undergoing Highly active antiretroviral therapy (HAART)
treatment will be included.
|
|
| ExclusionCriteria |
| Details |
HIV-SPP who were not on HAART, with chronic-renal-disease, chronic-kidney-disease,
rheumatoid-arthritis, cancer, on traditional alternative medicines, pregnant women, who refused
for medication adherence outcome assessment will be excluded. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| ADRs and CS-DDIs to HAART will be assessed and compared between both groups. |
Clinical data collection during the hospital stay
and/or follow up during the study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Medication adherence to HAART will be assessed using AIDS Clinical Trail Group (ACTG) adherence questionnaire. |
Clinical data collection during the hospital stay
and/or follow up during the study period. |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
15/11/2017 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Study just began on 15/11/2017 after receiving the IEC approval and hence have not yet commenced publishing procedures. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Assessment of Adverse drug reactions, drug-drug Interactions and medication adherence outcomes among elderly HIV seropositive patients in comparison with young HIV seropositive patients undergoing highly active antiretroviral therapy
Type of Study: Prospective
Aim: Assess adverse drug reactions (ADRs), clinically significant Drug-Drug Interactions (CS-DDIs and medication adherence (Med-ADH) outcomes among elderly HIV seropositive patients (ELD-HIV-SPP) in comparison with young HIV seropositive patients (YOU-HIV-SPP) undergoing highly active antiretroviral therapy (HAART). Objectives: 1. Assess pattern, risk factors for ADRs to HAART among ELD-HIV-SPP in comparison with YOU-HIV-SPP . 2. Assess factors affecting Med-ADH and their outcomes to HAART among ELD-HIV-SPP in comparison with YOU-HIV-SPP. 3. Assess possible CS-DDIs of HAART among ELD-HIV-SPP in comparison with YOU-HIV-SPP . 4. Identify, incidence, prevalence, pattern of occurrence and management of DDIs and their outcomes to HAART treatment among ELD-HIV-SPP in comparison with YOU-HIV-SPP.
Justification for study: HAART usage has decreased AIDS-related mortality. Life-threatening condition of HIV is now manageable and more people are growing older with HIV. India has third highest burden of HIV/acquired immunodeficiency syndrome (AIDS); National AIDS Control Organization (NACO) offers free HAART for HIV and related opportunistic infections. According to NACO guidelines,adherence should be maintained at a minimum of 95% in order to maintain clinical effectiveness and minimize development of drug-resistance. Failure in HIV treatment is due to drug intolerance or ADRs; unfortunately, 84% of HIV patients discontinue their initial HAART within the first 8 months of therapy due to ADRs. Among healthcare professionals in India, there is a lack of recognition for possible CS-DDIs in HIV patients. DDIs are pharmacokinetic and pharmacodynamic interactions, some are minor in severity, while some are potentially serious leading to treatment failure and toxicity. In HIV-SPP, there is an increase in Opportunistic Infections (OIs), comorbid diseases, non-Acquired Immunodeficiency Syndrome (AIDS) related malignancies, thus wide range of drugs are used along with HAART which causes DDIs. To date, no study has been published from India on the ADRs and Med-ADH outcomes, CS-DDIs among ELD-HIV-SPP in comparison with YOU-HIV-SPP undergoing HAART.
Sample size : 300 Patients
Detailed description of processes: HIV-SPP ≥ 18 years of age undergoing HAART treatment will be enrolled after obtaining Informed consent and divided into 2 groups ELD-HIV-SPP(Cases)>50years age and YOU-HIV-SPP(Controls)<49years age. Patients will be monitored for CS-DDIs to HAART. DDIs are assessed using University of Liverpool drug interaction database (ULPDIDB) and Micromedex database (MDB). CS-DDIs Severity level assessed using Stockley’s drug Interactions.As per ULPDIDB criteria, DDIs will be classified into 3 based on indications: Red Flag Indication (RFI), Orange Flag Indication (OFI), Green Flag Indication (GFI). World Health Organization (WHO) clinical staging of HIV disease in adults, adolescents and children will be used to assess the stage of HIV disease.CS-DDIs is defined as those drug interactions that needed a dosage adjustment or drug combination that is contraindicated due to its greater potential for adverse clinical effects. Patients will be monitored for ADRs to HAART, assessed for possible risk factors and their outcomes to HAART. ADR Causality assessment using WHO probability scale and Naranjo’s scale.Severity assessment of ADRs using Modified Hartwig and Siegel scale. Modified Shumock and Thornton criteria will be used to assess preventability of ADRs. Relevant data will be collected from patient’s case-records and documented in suitably designed ‘Individual-case-record-form’ (ICRF) including: implication of HAART, OIs, number of drug prescribed, demographic details of patients, CD4 T-cell counts. AIDS Clinical Trail Group (ACTG) adherence questionnaire will be used for Med-ADH assessment. Patients will be asked to recall and report number of missed antiretroviral doses in last one month (each missed medication regarded as one dose). Percentage of adherence from self-report will be calculated by using the formula.
Percentage of adherence = [No. of doses the patient should have taken – No .of doses missed / No. of doses the patient should have taken] × 100 |