Randomised Controlled Trial Assessing the Impact of Genital Herpes Suppressive Therapy on HIV Shedding
Information source: French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Genitalis; HIV Infection
Intervention: Valacyclovir (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: French National Agency for Research on AIDS and Viral Hepatitis Official(s) and/or principal investigator(s): Nicolas Nagot, Principal Investigator, Affiliation: London School of Hygiene and Tropical Medicine Philippe Mayaud, Study Chair, Affiliation: London School of Hygiene and Tropical Medicine Philippe Van de Perre, Study Chair, Affiliation: Montpellier University, France
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Primary outcome: To assess the impact of HSV-2 suppressive therapy on HIV shedding among co-infected women taking highly active antiretroviral therapy (HAART) or not needing HAART
Secondary outcome: To assess the impact of HSV-2 suppressive therapy on HSV-2 shedding among co-infected women taking HAART or not needing HAART
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 1g/day
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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Infection with HIV-1 and HSV-2
- If required to take antiretrovirals according to WHO recommendations, should be on
HAART for at least 4 months
- Written informed consent
Exclusion Criteria:
- Pregnancy or willing to be pregnant during the next 6 months
- Breastfeeding
- Renal failure
- Expected non-compliance with follow-up or study treatment
Locations and Contacts
Service d'Hygiene du Centre Muraz, Bobo-Dioulasso, Burkina Faso
Additional Information
Starting date: August 2004
Last updated: June 6, 2006
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