AIDS (Acquired Immune Deficiency Syndrome) is a disease of the human immune system caused by HIV infectio. This condition progressively reduces the effectiveness of the immune system and leaves individuals susceptible to opportunistic infections and tumors
Current treatments are as follow: Combination of antiretroviral drugs and prophylaxis for opportunistic infections.
Use of potent combination of antiretroviral drugs for HIV therapy (highly active antiretroviral therapy [HAART]) aims to reduce the plasma HIV RNA level and restore the CD4 count
Antiretrovirals can have serious adverse effects
FARAMIR is a product which has Antiviral effect without any . Toxicological studies on laboratory animals revealed no adverse effects on reproduction in experimental doses neither allergic nor immunologic effects. Therefore, we conducted this study to evaluate SAFETY AND EFFICASY OF “FARAMIR” IN HIV POSITIVE PATIENTS.
The study is designed as an exploratory clinical trial, a total of 12 patients infected with HIV who are antiretroviral naïve will be screened and enrolled. HIV infection is documented by licensed ELISA confirmed by Western blot. These patients are divided into two groups. The first group consists of six patients with CD4+ count of ≥200 and <350. The CD4+ count value in the second group is ≥350 and <500
The study will be done in one center in Iran. All patients will be treated by FARAMIR 1g/day (3 tablets per day) every day for 3 months. inclusion criteria:
1- 18-65 year old Asymptomatic HIV positive patients.
2- VIRAL LOAD>1000
3-PLT>50000
4-Hb>8
5-alt, ast<3
6-cr<1.5
exclusion criteria:
1- HBV or HCV infection
2- pregnancy
3- breast feeding
4-HSV infection
5-drug abuse or alcohol consumption
6-any investigational therapy within 6 months prior to study
primary outcome measure: viral load, CD4 count
secondary outcome: Appearance of any drug side effects
7-Chronic treatment with immunosuppressant drugs (topical steroids are permitted
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112124076N6
Registration date:2012-12-18, 1391/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-18, 1391/09/28
Registrant information
Name
Minoo Mohraz
Name of organization / entity
Iranian Research Center for HIV/AIDS, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 7984
Email address
minoomohraz@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-02-04, 1390/11/15
Expected recruitment end date
2013-02-03, 1391/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of Faramir in HIV positive patients.
Public title
Safety and efficacy of Faramir in HIV positive patients.
Purpose
Treatment
Inclusion/Exclusion criteria
These patients are divided into two groups. The first group consists of six patients with CD4+ count of ≥200 and <350. The CD4+ count value in the second group is ≥350 and <500.
Inclusions Criteria 1- HIV-1-infected adults aged 18-65 years old 2- Asymptomatic HIV positive patients 3- Patients naïve to any antiretroviral or immunomodulatory therapy 4- Plasma HIV-1 RNA of ≥1000 copies/mL 5- For the first group, CD4+ T-cell count ≥200 and <350 and for the second group, CD4+ T-cell count ≥350 and <500. 6- Adequate hematologic function (absolute neutrophil count ≥1000/μL, platelets ≥50×103/μL, hemoglobin ≥8.0 g/dL) 7- Adequate hepatic function (transaminases ≤3 × upper limit of normal.
consent Exclusions Criteria 1- Patients with any medical conditions or required medications that may compromise their safety or interfere with drug absorption. 2- Patients with hepatitis B and C antigen. 3- Required use of prohibited medications (CD4+ <200 is the indication of HAART according to the Iranian therapeutic guideline). 4- Creatinine clearance estimated by the Cockcroft-Gault equation of <50 mL/min. 5- Pregnancy or breast-feeding. 6- Concurrent HSV infection. 7- Active drug abuse or alcohol consumption. 8- Any application history of immunomodulator and HIV or tropical diseases vaccines. 9- Use of any investigational therapy within 6 months prior to study. 10- Use of human growth hormone within 30 days prior to study entry.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
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
Tehran University of Medical Sciences
Street address
Ghods St , Keshavrz BLV
City
Tehran
Postal code
1417653761
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
33333333
Health conditions studied
1
Description of health condition studied
Human immunodeficiency virus [HIV] disease
ICD-10 code
B24
ICD-10 code description
Unspecified human immunodeficiency virus [HIV] disease
Primary outcomes
1
Description
T lymphocyte CD4 count
Timepoint
baseline and weeks: 2, 4, 8, 12, 24, 30 and 36 from the begining of the study
Method of measurement
Lab test
2
Description
Viral Load
Timepoint
baseline and weeks: 2, 4, 8, 12, 24, 30 and 36 from the begining of the study
Method of measurement
Lab test/ RTPCR
Secondary outcomes
1
Description
Appearance of any drug side effects
Timepoint
Performed at each visit
Method of measurement
Regular clinical and laboratory assessments and filling out their relevant questionnaires
Intervention groups
1
Description
HIV positive patients confirm by Western Blot test who need antiviral treatment will recruit in our study.
Drug efficacy and side effect will observe by physical exam (Medical Doctor) and lab test.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Research Center for HIV/AIDS, Triangular clinic for sexual and behavioral disease.
Full name of responsible person
Dr.Seyed aham Seyed Alinaghi
Street address
Imam Hospital, Keshavarz BLVd , Valiasr Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pars Roos Co
Full name of responsible person
Dr.Madani
Street address
No 54, First Ghlestan, Pasdaran st.
City
Tehran
Grant name
Grant code / Reference number
90-03-159-16802
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pars Roos 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
Iranian Research center for HIV/AIDS
Full name of responsible person
Seyed Ahmad Seyed Alinaghi
Position
MD
Other areas of specialty/work
Street address
Imam khomeini hospital,Keshavarz BLVd
City
Tehran
Postal code
1419733141
Phone
+98 21 6694 7984
Fax
+98 21 6694 7984
Email
s_a_alinaghi@yahoo.com
Web page address
www.ircha.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Research center for HIV/AIDS TUMS
Full name of responsible person
Dr.Minoo Mohraz
Position
Professor
Other areas of specialty/work
Street address
Imam khomeini Hospital Tehran
City
Tehran
Postal code
1419733141
Phone
+98 21 6694 7984
Fax
+98 21 6694 7984
Email
minoomohraz@ams.ac.ir
Web page address
www.ircha.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iranian Research center for HIV AIDS (IRCHA TUMS)
Full name of responsible person
Seyed Ahmad Seyed Alinaghi
Position
Medical Doctor
Other areas of specialty/work
Street address
Imam Khomeini Hospital
City
Tehran
Postal code
1419733141
Phone
+98 21 6694 7984
Fax
+98 21 6694 7984
Email
a_s_alinaghi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)