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The Effect of Adjuvant IMOD therapy on the Immunological Status of HIV-positive Patients: A Random Controlled Clinical Trial

Protocol summary

Summary
Objectives : Determining the effects of adding the Iranian medicine IMOD to HAART regimen on the immunological condition of HIV+ patients Design: In this random controlled clinical trial, after explaining the study to the patients and obtaining written consent from them, 60 HIV+ patients for whom HAART was indicated were divided into the two identical groups: the control, who received only HAART, and the intervention group, who received infusion of IMOD in addition to HAART. Randomization was carried out through using simple random sampling. Setting and conduct : The HAART regimen used in this study for patients in both groups included NNRTI + 2NRTI. IMOD was in 120 mg vials in 4 cc, which was diluted in 50-100 cc of 5% dextrose and injected intravenously in half an hour. Patients received one ampoule (vial) of IMOD daily for a maximum period of 90 days. Observation, examination, equipment, and laboratory information were the information collecting tools in this research. Participants including : HIV+ patients (with two positive ELIISA tests and one positive Southern blot analysis) for whom HAART was indicated Interventions: Intravenous administration of IMOD Main outcome measures : Before and after the treatment, BUN, Cr, total lymphocyte count (TLC), CD4, CBC, and liver function tests (LFTs) were conducted and the results were collected as base information and, during and after the treatment, clinical statuses of the patients, treatment progress, and laboratory information were recorded in the files.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015070423046N1
Registration date: 2015-09-10, 1394/06/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-10, 1394/06/19
Registrant information
Name
Mehdi Gholamzadeh Baeis
Name of organization / entity
Qom Branch Of Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 61 3391 8586
Email address
dr.m.gholamzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Qom Branch Of Islamic Azad University
Expected recruitment start date
2013-08-05, 1392/05/14
Expected recruitment end date
2014-02-09, 1392/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Adjuvant IMOD therapy on the Immunological Status of HIV-positive Patients: A Random Controlled Clinical Trial
Public title
The effect of adding IMOD Iranian drug in HIV-positive patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: HIV-positive patients (with two positive ELISA tests and a positive Western blot test) with Indications for treatment with HAART regimen Exclusion criteria: The patient withdrew from the study of cooperation
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization were Simple randomly.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qom Univercity of Medical Science
Street address
Qom Univercity of medical science , Saheli Street , Qom
City
Qom
Postal code
Approval date
2015-06-18, 1394/03/28
Ethics committee reference number
IR.MUQ.REC.1394.30

Health conditions studied

1

Description of health condition studied
AIDS
ICD-10 code
B20-B24
ICD-10 code description
Human immunodeficiency virus [HIV] disease

Primary outcomes

1

Description
CD4 (cluster of differentiation 4)
Timepoint
Before and after the interventions(After 90 days)
Method of measurement
Flow cytometry

2

Description
TLC ( Total lymphocyte count )
Timepoint
Before and after the interventions(After 90 days)
Method of measurement
CBC Diff

Secondary outcomes

1

Description
BUN , Cr
Timepoint
Before and after the interventions(After 90 days)
Method of measurement
Routine laboratory scale measurements

2

Description
liver function tests (LFT)
Timepoint
Before and after the interventions(After 90 days)
Method of measurement
Routine laboratory scale measurements

Intervention groups

1

Description
Intervention group: patients underwent IMOD infusion in addition to HAART therapy. IMOD vials contain 120 mg in 4 cc. It was diluted in 50 to 100 ml of 5% dextrose and administrated within half an hour through intravenous infusion (IV). The maximum duration of IMOD infusion was 90 days (daily injections. *The HAART regimen used in both groups.
Category
Treatment - Drugs

2

Description
Control group: The HAART regimen that includes 1 NNRTI + 2 NRTI. *nucleoside reverse transcriptase inhibitors (NRTIs) **non-nucleoside reverse transcriptase inhibitors (NNRTIs)
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Counseling Center For Behavioral Diseases in Qom
Full name of responsible person
Ghasem Amiri
Street address
22th Street, Bu Ali Street, Istgah Avenue, Qom
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Of Qom Branch Of Islamic Azad University - Counseling Center for Behavi
Full name of responsible person
Dr.Ghasem Amiri
Street address
Qom , Kamkar Arabnya Hospital
City
Qom
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 Qom Branch Of Islamic Azad University - Counseling Center for Behavi
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
Qom Branch Of Islamic Azad University
Full name of responsible person
Mehdi Gholamzadeh Baees
Position
Student Of M.D
Other areas of specialty/work
Street address
School of Medicine, Islamic Azad University, 15 Khordad street, Qom
City
Qom
Postal code
Phone
+98 25 3778 0001
Fax
Email
Dr.M.Gholamzadeh@Gmail.com; Mehdi_Mephisto@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Dr.Ghasem Amiri
Position
Infectious Disease Specialist
Other areas of specialty/work
Street address
Kamkar Arabniya Hospital
City
Qom
Postal code
Phone
+98 25 3771 3511
Fax
Email
dr.ghasem.amiri@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom branch Of Islamic Azad university
Full name of responsible person
Mehdi Gholamzdeh Baees
Position
Student Of M.D
Other areas of specialty/work
Street address
City
Qom
Postal code
Phone
+98 61 3391 8586
Fax
+98 61 3391 8586
Email
Dr.M.Gholamzadeh@Gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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