In this randomized, double-blind, clinical trial study the aim is to assess the effects of CoQ 10 on patients infected with human immunodeficiency virus. In all patients, CD4 at baseline will be measured by flow cytometry. BUN, Cr, liver enzymes plasma level and CBC is measured and recorded. Then patients will be randomly divided into two groups using block randomization method. One group will receive 200 mg/day CoQ 10 and the other group will receive placebo which is in similar shape, color and size to the CoQ10 drug. All the parameters that had been measured a baseline will be measured again after 3 months and will be compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108027197N1
Registration date:2013-11-13, 1392/08/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-13, 1392/08/22
Registrant information
Name
Farid Yousefi
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1333 5935
Email address
drfayo@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Coenzyme Q10 in comparison with placebo on CD4 in HIV-infected patients
Public title
The Therapeutic Effect of Coenzyme Q10 in HIV-Infected Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :
HIV-infected adults that HIV confirmed with 2 positive result of ELISA and western blot test and they are in treatment with ART
Exclusion criteria:
1- Lymphoma or other malignancies
2- Corticosteroids usage
3- Autoimmune Diseases
4- Advanced Pulmonary Tuberculosis
5- Pregnancy
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients and outcome assessor are blind to treatment groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Postal code
Approval date
2011-05-21, 1390/02/31
Ethics committee reference number
ETH-152
Health conditions studied
1
Description of health condition studied
Human immunodeficiency virus
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus disease
Primary outcomes
1
Description
CD4 level
Timepoint
Base line and 3 months after initiation of treatment
Method of measurement
flow cytometry method
Secondary outcomes
1
Description
ALT
Timepoint
Baseline and 3 months after initiation of treatment
Method of measurement
Device analysis
2
Description
AST
Timepoint
Baseline and 3 months after initiation of treatment
Method of measurement
Device analysis
3
Description
BUN
Timepoint
Baseline and 3 months after initiation of treatment
Method of measurement
Device analysis
4
Description
Cr
Timepoint
Baseline and 3 months after initiation of treatment
Method of measurement
Device analysis
5
Description
CBC
Timepoint
Baseline and 3 months after initiation of treatment
Method of measurement
Device analysis
Intervention groups
1
Description
CoQ10 200 mg/day for 3 months
Category
Treatment - Drugs
2
Description
Placebo 200 mg/day for 3 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Mohammadreza Abbaspour
Street address
Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Roozbeh
Position
Resident
Other areas of specialty/work
Street address
Razi Hospital
City
Ahvaz
Postal code
Phone
+98 61 1333 3050
Fax
Email
fatemehroozbeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Farid Yousefi
Position
Assistant professor
Other areas of specialty/work
Street address
Razi Hospital
City
Ahvaz
Postal code
Phone
+98 61 1333 3050
Fax
Email
drfayo@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Fatemeh Roozbeh
Position
Resident
Other areas of specialty/work
Street address
Razi Hospital
City
Ahvaz
Postal code
Phone
+98 61 1333 3050
Fax
Email
fatemehroozbeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)