There are limited numbers of studies which have been done on role of herpes simplex virus type-2 (HSV-2) infection on human immunodeficiency virus (HIV)-1 progression among HIV infected patients. This study will be a Randomized double blind placebo-controlled trial study and will be done in two phases.
First phase: 90 HIV positive patients with positive serology for HSV-2 and 90 HIV positive patients without this marker as a control group will be recruited in this study. The participants in both groups will be followed up and compared in respect of HIV progression toward AIDS. This follow up will consist of CD4 count and HIV-1 viral load checking in first recruitment (baseline) and then after 1 year. These two groups will be compared regarding HIV progression toward AIDS. Inclusion criteria include: HIV positive patients with CD4 count of 400-900 cells/mm3 and not being under antiviral therapy.
Second phase: Through this phase, clinical trial with two parallel RCT will be done. In this purpose, HIV-1/HSV-2 co-infected patients will be divided in two groups and will be treated randomly by Acyclovir versus placebo. Two groups will be checked and compared based on CD4 count and HIV-1 viral load after one year.
General information
Acronym
Evaluating the association of HSV2 in HIV infection
IRCT registration information
IRCT registration number:IRCT201311094076N12
Registration date:2014-01-12, 1392/10/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-12, 1392/10/22
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
Resaerch Deputy tehran university of medical sciences
Expected recruitment start date
2013-11-22, 1392/09/01
Expected recruitment end date
2014-07-21, 1393/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the association of HSV2 infection in HIV progression in HIV positive patients.
Public title
Evaluating the association of HSV2 infection in HIV progression in HIV positive patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: HIV positive patients referred to Iranian Research Center for HIV/AIDS-Imam Khomeini Hospital with CD4 count of 400-900 cells/mm3 and not being under antiviral therapy.
Exclusion criteria: CD4 count above 400-900 cells/mm3; co infected with either HBV or HCV; having genital wart.
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iranian Research Center for HIV/AIDS
Street address
Imam Hospital. Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2013-11-22, 1392/09/01
Ethics committee reference number
92-02-55-23696
Health conditions studied
1
Description of health condition studied
HIV AIDS
ICD-10 code
B24
ICD-10 code description
Human immunodeficiency virus [HIV]
Primary outcomes
1
Description
CD4 Count
Timepoint
1 year after intervention and starting for treatment
Method of measurement
Blood Test
2
Description
Viral Load
Timepoint
1 year after intervention and starting for treatment
Method of measurement
Blood Test
Secondary outcomes
1
Description
HIV progression
Timepoint
1 year after starting the project
Method of measurement
lab tests and physical exams
Intervention groups
1
Description
Intervention Group:
Through this phase, clinical trial with two parallel RCT will be done. In this purpose, HIV-1/HSV-2 co-infected patients will be divided in two groups, 45 participants in each group and will be treated randomly by Acyclovir .
Two groups will be checked and compared based on CD4 count and HIV-1 viral load after one year.
Category
Treatment - Drugs
2
Description
Control Group:
45 HIV HSV2 positive participants will be recruit in this phase as control group ,
there is no drug treatment or intervention for this group.
After 1 year from the study baseline we will get a blood test for evaluate CD4 count and viral load for comparing with intervention group.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Research Center for HIV/AIDS
Full name of responsible person
Minoo Mohraz
Street address
Iranian Research Center for HIV/AIDS, Imam Hospital.keshavarz Blvd Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Resaerch Deputy tehran university of medical sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Ghods Avn , Keshavarz Blvd Tehran Iran, Islamic Republic Of
City
Tehran
Grant name
غیر مستقل، گرنت سالیانه مرکز تحقیقات
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Resaerch Deputy tehran 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
Iranian research Center for HIV AIDS (IRCHA)
Full name of responsible person
Minoo Mohraz MD
Position
Head of IRCHA
Other areas of specialty/work
Street address
Iranian research Center for HIV AIDS (IRCHA),Imam Hospital, Keshavarz BLVd , Valiasr Sq Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
Phone
+98 21 6658 1583
Fax
Email
ircha@tums.ac.ir ircha.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian research Center for HIV AIDS (IRCHA)
Full name of responsible person
Minoo Mohraz MD
Position
Head of IRCHA
Other areas of specialty/work
Street address
Iranian research Center for HIV AIDS (IRCHA),Imam Hospital, Keshavarz BLVd , Valiasr Sq Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
Phone
+98 21 6658 1583
Fax
Email
ircha@tums.ac.ir ircha.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian research Center for HIV AIDS (IRCHA)
Full name of responsible person
Mona Mohammadi Firouzeh
Position
MS/Researcher
Other areas of specialty/work
Street address
Iranian research Center for HIV AIDS (IRCHA),Imam Hospital, Keshavarz BLVd , Valiasr Sq Tehran Iran, Islamic Republic Of
City
Tehran
Postal code
Phone
+98 21 6658 1583
Fax
Email
ircha@tums.ac.ir ircha.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)