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

NCT ID: NCT00161434

Last Updated: 2008-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2006-06-30

Brief 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.

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.

Conditions

Herpes Simplex; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

valacyclovir

Intervention Type: DRUG

1 gram daily for 8 weeks

2

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

matching placebo for 8 weeks

Interventions

valacyclovir

1 gram daily for 8 weeks

Intervention Type: DRUG

placebo

matching placebo for 8 weeks

Intervention Type: DRUG

Other Intervention Names

Valtrex

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

University of Washington

Principal Investigators

Anna Wald, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Virology Research Clinic

Seattle, Washington, United States

Countries

United States

Other Identifiers

P01AI030731

Identifier Type: NIH

Identifier Source: secondary_id

View Link

02-6505-A

Identifier Type: -

Identifier Source: org_study_id