Skip to main content
OpenTrials
Completed

NCT Number: NCT00161434

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Herpes Simplex Blood-Borne Infections Communicable Diseases DNA Virus Infections Genital Diseases HIV Infections Herpesviridae Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Virology Research Clinic

Seattle, Washington, 98122, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Valacyclovir

Drug

1 gram daily for 8 weeks

Other names: Valtrex

Placebo

Drug

matching placebo for 8 weeks

Primary outcomes

  1. To assess reduction in mucosal HIV shedding associated with daily valacyclovir for suppression of HSV-2 reactivation.

    Time frame: 18 weeks

Secondary outcomes

  1. 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.

    Time frame: 18 weeks

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • GlaxoSmithKline
  • National Institutes of Health (NIH)

Registry information

Official study title

A Randomized, Double-Blind, Placebo Controlled Crossover Trial Using Valacyclovir to Suppress HSV and HIV Shedding in HIV-1, HSV-2 Coinfected Persons

Important dates

Study start
2003
Primary completion
2006
Study completion
2006
First posted
Sep 12, 2005
Registry last updated
Jan 10, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.