Determination of the effect of sovodak on viral load reduction in patients with concurrent hepatitis C and HIV
Design
clinical trial without control group with sample size of 26 patients
Settings and conduct
In the present before-after study, patients with hepatitis C and HIV will received Sovodak for 3 months. Neither the patients, nor the researcher were not blind
Participants/Inclusion and exclusion criteria
The patients infected with HIV virus who get anti retroviral treatments and simultaneously infected with hepatitis C virus.
Intervention groups
Intervention group: patients with hepatitis C and HIV will received Sovodak for 3 months
Main outcome variables
Viral load
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180924041107N1
Registration date:2018-11-19, 1397/08/28
Registration timing:registered_while_recruiting
Last update:2018-11-19, 1397/08/28
Update count:0
Registration date
2018-11-19, 1397/08/28
Registrant information
Name
Roya Sedghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3385 4686
Email address
r.sedghi111@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-11, 1397/05/20
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to investigate effectiveness of Sovodak on viral load in patients with concurrent hepatitis C and HIV-1
Public title
effect of Sovodak in patients with hepatitis C and HIV-1
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients infected with HIV virus who get anti retroviral treatments and simultaneously infected with hepatitis C virus.
Exclusion criteria:
patients who previously received treatments for hepatitis C
patients with kidney disease
patients with advanced cirrhosis
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
22
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of medical sciences
Street address
Tabriz University of Medical Sciences; Golgasht Streat.
City
Tabriz
Province
East Azarbaijan
Postal code
3456754326
Approval date
2018-08-27, 1397/06/05
Ethics committee reference number
IR.TBZMED.REC.1397.439
Health conditions studied
1
Description of health condition studied
Hepatitis C and HIV
ICD-10 code
B17.1
ICD-10 code description
Acute hepatitis C
2
Description of health condition studied
Human immunodeficiency virus
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
Viral load
Timepoint
before treatments and 3 months after treatments
Method of measurement
RTPCR
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: SOVODAK treatment for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
provincial health center
Full name of responsible person
Roya Sedghi
Street address
provincial health center; Segatoleslam St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 6828
Email
r.sedghi111@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Tabriz University of medical sciences, Golgasht street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 1688
Email
lgdrc2005@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roya Sedghi
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza hospital, Tabriz University of medical sciences, Daneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 1688
Email
r.sedghi111@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roya Sedghi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Reza hospital, Tabriz University of medical sciences, Daneshgah street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 1688
Email
r.sedghi111@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roya Sedghi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Imam reza hospital, Tabiz University of medical sciences, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 1688
Email
r.sedghi111@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available