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The Effect of Adjuvant IMOD therapy on the Immunological Status of HIV-positive Patients: A Double-Blind Randomized Controlled Trial
Last registered on June 25, 2015

Pre-Trial

Trial Information
General Information
Title
The Effect of Adjuvant IMOD therapy on the Immunological Status of HIV-positive Patients: A Double-Blind Randomized Controlled Trial
RCT ID
AEARCTR-0000745
Initial registration date
June 25, 2015
Last updated
June 25, 2015 4:19 PM EDT
Location(s)
Primary Investigator
Affiliation
Student Of Medical Doctor Of Qom Branch Of Islamic Azad Univercity
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2013-12-05
End date
2014-07-23
Secondary IDs
Abstract
Introduction: HIV infection is a major threat to global health. So far, it has claimed the lives of 25 million people in the world. Recently, Iranian scientists have produced a drug called IMOD to strengthen the immune system. The present study examines the effect of addition of IMOD to the HAART regimen on the immunological status of HIV-positive patients referred to the Counseling Center for Behavioral Diseases in Qom in 2013.
Methods: In a parallel Double-Blind Randomized Controlled Trial 60 HIV-positive patients with indications for treatment with HAART regimen were enrolled. The participants were randomly assigned, following simple randomization procedures (1 : 1), to receive IMOD or placebo along with the common treatments Participants and those assessing the outcomes were blinded to group assignment. Patient assigned to placebo received the same solution as IMOD but without IMOD Active ingredients control group those received HAART therapy and the intervention group (the patients underwent IMOD infusion in addition to HAART therapy). The IMOD used in this study was a vial containing 120 mg in 4 ml. Random sampling was performed. CBC, LFT,BUN, Cr, TLC, CD4 were measured before and after treatment. The collected data were analyzed using SPSS 16.
Results: The mean age of patients in the intervention and control groups was 35.5 ± 5.97 and 34 ± 6.72 years, respectively. The CD4 changes in women received IMOD was significant (P <0.05). A significant correlation was found between CD4 changes and age in the intervention group (P <0.05). A significant correlation was found between the mean CD4 counts before and after treatment in the intervention group (P = 0.041). A significant difference was also found between the CD4 counts before and after treatment in the intervention group (P = 0.003). There was no significant difference between the mean TLC before and after treatment in the intervention group (P = 0.938).
Conclusion: According to the results, IMOD can be included in the drug regimen of HIV-positive patients or those with AIDS to enhance the immunological status.
Keywords: IMOD, HAART, HIV +, AIDS, CD4
External Link(s)
Registration Citation
Citation
Gholamzadeh Baees, Mehdi. 2015. "The Effect of Adjuvant IMOD therapy on the Immunological Status of HIV-positive Patients: A Double-Blind Randomized Controlled Trial." AEA RCT Registry. June 25. https://doi.org/10.1257/rct.745-1.0.
Former Citation
Gholamzadeh Baees, Mehdi. 2015. "The Effect of Adjuvant IMOD therapy on the Immunological Status of HIV-positive Patients: A Double-Blind Randomized Controlled Trial." AEA RCT Registry. June 25. https://www.socialscienceregistry.org/trials/745/history/4559.
Experimental Details
Interventions
Intervention(s)
In a parallel Double-Blind Randomized Controlled Trial 60 HIV-positive patients with indications for treatment with HAART regimen were enrolled. The participants were randomly assigned, following simple randomization procedures (1 : 1), to receive IMOD or placebo along with the common treatments Participants and those assessing the outcomes were blinded to group assignment. Patient assigned to placebo received the same solution as IMOD but without IMOD Active ingredients control group those received HAART therapy and the intervention group (the patients underwent IMOD infusion in addition to HAART therapy). The IMOD used in this study was a vial containing 120 mg in 4 ml. Random sampling was performed. CBC, LFT,BUN, Cr, TLC, CD4 were measured before and after treatment. The collected data were analyzed using SPSS 16.
Intervention Start Date
2014-02-11
Intervention End Date
2014-05-15
Primary Outcomes
Primary Outcomes (end points)
The mean age of patients in the intervention and control groups was 35.5 ± 5.97 and 34 ± 6.72 years, respectively. The CD4 changes in women received IMOD was significant (P <0.05). A significant correlation was found between CD4 changes and age in the intervention group (P <0.05). A significant correlation was found between the mean CD4 counts before and after treatment in the intervention group (P = 0.041). A significant difference was also found between the CD4 counts before and after treatment in the intervention group (P = 0.003). There was no significant difference between the mean TLC before and after treatment in the intervention group (P = 0.938).
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
In a parallel Double-Blind Randomized Controlled Trial 60 HIV-positive patients with indications for treatment with HAART regimen were enrolled. The participants were randomly assigned, following simple randomization procedures (1 : 1), to receive IMOD or placebo along with the common treatments Participants and those assessing the outcomes were blinded to group assignment. Patient assigned to placebo received the same solution as IMOD but without IMOD Active ingredients control group those received HAART therapy and the intervention group (the patients underwent IMOD infusion in addition to HAART therapy).
Experimental Design Details
Randomization Method
Block randomization, Generalized by Excel
Randomization Unit
No clustered or more than one level randomization
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
60
Sample size: planned number of observations
60
Sample size (or number of clusters) by treatment arms
30 patient in intervention group and 30 patient in control group
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Medical Ethic Committee of Qom University of medical science in Iran
IRB Approval Date
2015-06-18
IRB Approval Number
IR.MUQ.REC.1394.30
Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers