Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158509
Status:
COMPLETED
Last Update Posted:
2006-06-07
First Post:
2005-09-09
Brief Title:
Randomised Controlled Trial Assessing the Impact of Genital Herpes Suppressive Therapy on HIV Shedding
Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Organization:
French National Agency for Research on AIDS and Viral Hepatitis
Study Overview
Official Title:
Efficacy of an HSV2 Genital Herpes Suppressive Treatment on HIV and HSV2 Genital Shedding Among Co-Infected Patients Receiving or Not Antiretroviral Drugs
Status:
COMPLETED
Status Verified Date:
2006-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Genital herpes is a long-life sexually transmitted diseases which infects a large proportion of women in Africa Its clinical symptoms are painful sores on the genitals which heals after a few days HIV infection can worsen genital herpes In turn it is possible that genital herpes increases the quantity of HIV secreted at the genital level in women infected by the 2 viruses This study is dedicated to verify this hypothesis
Detailed Description:
Infection with Herpes Virus Simplex type 2 HSV-2 is likely to represent the main cofactor involved in HIV transmission either through clinical episodes or asymptomatic genital shedding However the definite proof of this concept has never been made through randomised controlled trials Furthermore the natural history of HSV-2 infection is poorly documented in sub-Saharan Africa as well as the efficacy of the antiviral drug on virus transmission The latter can be measured by HSV-2 genital shedding as a proxy
The objectives of this research programme are to assess the impact of a suppressive treatment for genital herpes on HIV genital shedding among co-infected patients receiving HAART or not needing antiretroviral ARV drugs
In order to achieve these objectives we propose to perform 2 randomised double blind controlled trials nested within the ongoing cohort of sex workers in Bobo-Dioulasso
While the increase of HIV transmission by HSV-2 infection stands as our main working hypothesis among HIV positive persons the specific rationale for individuals taking ARV is the following Does the potential cofactor effect of genital herpes on HIV remain present when the immunity is built up by ARV In other words is HSV-2 infection a public health issue in this group of people The role of ARV on HIV transmission will also be assessed
These 2 trials will be performed using exactly the same methodology and the same study treatment We will use a parallel design with a baseline phase to take into account the important inter-individual variability of genital shedding Each participant will be its own control The baseline phase and treatment phases will each consist of 6 visits performed at a 2 weeks interval The participants will receive either placebo or Valacyclovir 1gday during the treatment phase 3 months
The outcomes will be measured using both a qualitative and a quantitative measure of HIV shedding The analysis will be conducted using an intention to treat and a per protocol approach
At the end of our project the working hypothesis will be much documented in women taking ARV or not Furthermore our results will constitute a reference for an upcoming therapeutic vaccine trial
This work results from the collaboration of the Centre Muraz the UMR 36 AIDS and associated diseases Montpellier and the London School of Hygiene Tropical Medicine
The objectives of this research programme are to assess the impact of a suppressive treatment for genital herpes on HIV genital shedding among co-infected patients receiving HAART or not needing antiretroviral ARV drugs
In order to achieve these objectives we propose to perform 2 randomised double blind controlled trials nested within the ongoing cohort of sex workers in Bobo-Dioulasso
While the increase of HIV transmission by HSV-2 infection stands as our main working hypothesis among HIV positive persons the specific rationale for individuals taking ARV is the following Does the potential cofactor effect of genital herpes on HIV remain present when the immunity is built up by ARV In other words is HSV-2 infection a public health issue in this group of people The role of ARV on HIV transmission will also be assessed
These 2 trials will be performed using exactly the same methodology and the same study treatment We will use a parallel design with a baseline phase to take into account the important inter-individual variability of genital shedding Each participant will be its own control The baseline phase and treatment phases will each consist of 6 visits performed at a 2 weeks interval The participants will receive either placebo or Valacyclovir 1gday during the treatment phase 3 months
The outcomes will be measured using both a qualitative and a quantitative measure of HIV shedding The analysis will be conducted using an intention to treat and a per protocol approach
At the end of our project the working hypothesis will be much documented in women taking ARV or not Furthermore our results will constitute a reference for an upcoming therapeutic vaccine trial
This work results from the collaboration of the Centre Muraz the UMR 36 AIDS and associated diseases Montpellier and the London School of Hygiene Tropical Medicine
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None