HIV /AIDS is a worldwide infection. Treatment of patients is an important challenge for physicians. IMOD has been registered in Islamic Republic of Iran for treatment of HIV/AIDS patients. It is an immunomudolatory drug and can significantly increase the CD4 lymphocyte number in these patients. This study will be conducted as a phase II clinical trial without control group in Syria. Patients will be recruited in Damascus AIDS center. The inclusion criterion is: patients having CD4 lymphocyte count less than 400. Patients will receive IMOD for 3 months with standard antiviral medications. Main exclusion criteria: Evidence of malignancy, Presence of life threatening conditions such as hepatic or renal failure or congestive heart failure, Presence of life threatening infections or other serious and dangerous infections, Presence of liver function disorders in laboratory tests including elevation of liver enzymes or Bilirubin level more than 3 times of the upper limit of the normal range, Treatment with corticosteroids, immune suppressants, radiotherapy or chemotherapy. 15 HIV positive patients having the eligibility criteria will be recruited. Written informed consent will be obtained. All subjects will receive intravenous IMOD equivalent of 100 mg active ingredient daily for 3 month. CD4 lymphocyte count, viral load and quality of life in patients will be assessed before and after receiving the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904084272N1
Registration date:2010-08-26, 1389/06/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-08-26, 1389/06/04
Registrant information
Name
Dr Faten Al akkad
Name of organization / entity
Ministry of Health, Syria
Country
Syrian Arab Republic
Phone
00963112758133
Email address
dqc.dir@moh.gov.sy
Recruitment status
Recruitment complete
Funding source
Pars Roos Biotechnology Company, Tehran, Iran
Expected recruitment start date
2010-07-11, 1389/04/20
Expected recruitment end date
2010-12-11, 1389/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of IMOD in HIV/AIDS patients
Public title
Phase II single arm clinical trial to evaluate safety and efficacy of IMOD in HIV/AIDS patients in Syria
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
• Diagnosis of HIV infection (two positive ELISA confirmed by one positive Western Blot test)
• Receiving HAART
• Age more than 18-75
Exclusion criteria
• Evidence of malignancy (diagnosed or presenting a sign or symptom of major cancer such as hemoptysis, chronic cough, rectal bleeding, etc) except for Kaposi’s sarcoma
• Presence of life threatening conditions such as hepatic or renal failure or congestive heart failure
• Presence of life threatening infections or other serious and dangerous infections
• Presence of liver function disorders in laboratory tests including elevation of liver enzymes or Bilirubin level more than 3 times of the upper limit of the normal range
• Drug and alcohol abuse (more than 21 units alcohol for males and 14 units for females)
• Treatment with corticosteroids, immune suppressants, radiotherapy or chemotherapy
• Any known drug hypersensitivity
• Inability or refusal to sign the informed consent
• Receiving any investigational drug within 30 days prior to screening
• Pregnancy or intention of becoming pregnant during the study period
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
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
Syria Ministry of Health Ethics committee
Street address
Ministry of Health, Damascus, Syria
City
Damascus
Postal code
Approval date
empty
Ethics committee reference number
6504
Health conditions studied
1
Description of health condition studied
HIV/ AIDS
ICD-10 code
B24
ICD-10 code description
Unspecified human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
CD4 Lymphocyte count
Timepoint
At the beginning, First, second, third and fourth month of study.
Method of measurement
Flocytometry
Secondary outcomes
1
Description
Viral load
Timepoint
At the beginning and end of the study.
Method of measurement
Real Time Polymerase Chain Reaction test
2
Description
Quality of life
Timepoint
At the beginning and end of the study.
Method of measurement
Questionaire
Intervention groups
1
Description
Intrvenous injection of IMOD one vial daily for three months. Each vial contains 4ml IMOD. It will be diluted in 100ml of dextrose 5% solution before injection and will be administered within one hour
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Damascus AIDS center
Full name of responsible person
Dr. Rana Alayazra
Street address
Damascus AIDS center, Al zablataaneh
City
Damascus
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pars Roos Biotechnology Co.
Full name of responsible person
Dr. Koorosh Kamali
Street address
No 568, 13 th Alley, Hormozan St., Shahrak-e- gharb
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pars Roos Biotechnology Co.
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
Clinical trial Department
Full name of responsible person
Dr. Faten Alakkad
Position
Head of Department
Other areas of specialty/work
Street address
Clinical trial department, Al Mujtahid hospital, Al Midan, Damascus, Syria
City
Damascus
Province
Damascus
Postal code
Phone
00963112758133
Fax
Email
faten.alakkad@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Clinical trial department
Full name of responsible person
Dr. Faten Alakkad
Position
Head of department
Other areas of specialty/work
Street address
Clinical trial department, Al Mujtahid hospital, Al Midan, Damascus, Syria
City
Damascus
Province
Damascus
Postal code
Phone
00963112758133
Fax
Email
faten.alakkad@hotmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Clinical trial Department
Full name of responsible person
Dr. Faten Alakkad
Position
Head of department
Other areas of specialty/work
Street address
Clinical trial department, Al Mujtahid hospital, Al Midan, Damascus, Syria
City
Damascus
Province
Damascus
Postal code
Phone
00963112758133
Fax
Email
faten.alakkad@hotmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)