Can Valacyclovir Attenuate Inflammation in Antiretroviral-Treated HIV-Infected Individuals With Herpes Simplex Virus Type 2?

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the levels of immune and inflammatory markers among HIV-1, HSV-2 co-infected adults achieving plasma HIV RNA suppression to <50 copies/mL, between those randomized to valacyclovir and placebo, over a twelve-week intervention period.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborators: Canadian Institutes of Health Research (CIHR); University of Toronto
• Treatments: Acyclovir; Valacyclovir

Criteria

Inclusion Criteria:

• adult (aged 18 years or older)

• documented HIV-1 infection (determined by EIA and Western blot)

• documented HSV-2 seropositivity (determined by ELISA during screening)

• no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study

• sustained plasma HIV RNA<50 copies/mL on HAART for at least 12 months

• no active opportunistic infection for at least 12 months

Exclusion Criteria:

• hepatitis C co-infection

• hepatitis B co-infection

• pregnancy or actively planning to become pregnant

• receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications (e.g. interferon, azathioprine, methotrexate, TNF-alpha antagonists, etc.)

• Estimated creatinine clearance <30 mL/min

• Other medical condition likely to cause death within 24 months

• Enrolled in any other interventional clinical trial