A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV.
Full description
Sexually transmitted diseases and genital ulcer disease (GUD) contribute significantly to the spread of HIV, as their presence is associated with higher rates of HIV acquisition in susceptible individuals. Herpes simplex virus-2 (HSV-2) is a major cause of GUD in developed and developing countries.
The primary objective of this research study is to assess if daily valacyclovir therapy for suppression of HSV-2 reactivation is associated with a decrease in mucosal HIV shedding in individuals co-infected with both HSV-2 and HIV.
This study is a randomized, double-blind, placebo-controlled, crossover trial. Sixty men who have sex with men (MSM) will be randomized to first receive either valacyclovir, 1 gram once a day, or matching placebo for 8 weeks. After a 2-week washout period during which all participants receive placebo, subjects then switch to the other treatment for the next 8 weeks.
At screening, informed consent is obtained and individuals will have blood drawn to test antibody status to HIV and HSV and well as to monitor CD4 count and plasma HIV RNA determination. At enrollment, oral, genital, and rectal specimens are obtained and additional blood is drawn. Participants are given a two-week supply of study medication and are instructed on the technique of collecting daily home samples and completing a diary. Following enrollment, they are asked to collect daily home oral and genital samples, as well as semen samples twice a week, for the full 18 weeks of the study. Participants return to the clinic three times per week for follow-up, for collection of oral and rectal specimens, and additional study medication. Rectal Biopsy is performed at weeks 8 and 18 for those individuals that signed the additional rectal biopsy consent form.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- HIV seropositive and HSV-2 seropositive
- MSM (men having sex with men)
- 18 years old or older
Exclusion criteria
- Known history of adverse reaction to acyclovir or valacyclovir
- Planned open label use of acyclovir, valacyclovir or famciclovir
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal