A Study of Valacyclovir to Suppress HSV and HIV Shedding in Coinfected Persons

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00161434
• Other study ID #: 02-6505-A
• Secondary ID: P01AI030731
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2005
• Last updated: December 29, 2007
• Start date: March 2003
• Est. completion date: June 2006

Study information

• Verified date: December 2007
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Simplex
• HIV Infections

Intervention

Drug:
• valacyclovir
1 gram daily for 8 weeks
• placebo
matching placebo for 8 weeks

Locations

Country	Name	City	State
United States	Virology Research Clinic	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	GlaxoSmithKline, National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation.		18 weeks	No
Secondary	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.		18 weeks	No