A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons
Information source: University of Washington
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Simplex; HIV Infections
Intervention: valacyclovir (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University of Washington Official(s) and/or principal investigator(s):
Anna Wald, MD, MPH, Principal Investigator, Affiliation: University of Washington
Summary
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.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo Controlled Crossover Trial Using Valacyclovir to Suppress HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons
Study design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: To assess reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation.
Secondary outcome: To quantify increase in rectal and pharyngeal HIV-1 shedding associated with HSV-1 and HSV-2 reactivation. To determine reduction in systemic HIV RNA during valacyclovir therapy. To evaluate reduction in inflammatory cells and HIV replication.
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Virology Research Clinic, Seattle, Washington 98122, United States
Additional Information
Starting date: March 2003
Ending date: June 2006
Last updated: December 29, 2007
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