Official Title: “A Randomized,Double-Blind , Placebo-Controlled Crossover Trial of Antivirals for Suppression of HSV and HIV Shedding in HIV-1, HSV-2 Co-Infected Persons”

Over 80% of HIV-1 infected persons are also seropositive for HSV-2. Increasingly, clinical and epidemiologic evidence show the role of HSV in increasing HIV infectiousness. The evidence suggests that HSV is an important co-factor in HIV transmission.

The trial's purpose is to assess the reduction in HIV systemic and mucosal replication associated with valacyclovir for suppression of HSV-2 reactivation.

This randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected women assessed the effects of daily valacyclovir on HIV-1 levels in blood and body fluids.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: December 2005

Conducted in Lima Peru, 20 HIV-1 and HSV-2 seropositive women with CD4 counts greater than 200 and on no antiretroviral therapy were randomly assigned to receive valacyclovir 500 mg bid or placebo for the first 8 weeks of the study. After these 8 weeks, a 2-week washout period followed, which was then followed by the alternative regimen for 8 weeks.

Intervention(s) in this Clinical Trial

• Drug: Valacyclovir
  • 500mg oral twice daily
• Drug: Matching Placebo
  • 500 mg oral twice daily

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: I

Primary Measures

• Plasma HIV-1 levels and HIV-1 mucosal shedding
  • Time Frame: 18 weeks
    Safety Issue?: No

Secondary Measures

• Mucosal HSV-2 shedding
  • Time Frame: 18 weeks
    Safety Issue?: No
• Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation;
  • Time Frame: 18 weeks
    Safety Issue?: No

Inclusion Criteria:

• Greater than 18 years old woman,
• Documented HIV-1 seropositive,
• CD4 count greater than 200,
• Not on HIV antiretroviral therapy,
• HSV-2 seropositive as determined by Focus EIA (IN >3.5)
• Not intending to move out of the area for the duration of study participation.
• Willing and able to:provide independent written informed consent;undergo clinical evaluations;take study drug as directed;adhere to follow-up schedule.
• Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea and syphilis) are treated within two weeks of study enrollment and random assignment.

Exclusion Criteria:

Women who meet any of the following criteria are not eligible for this study:

• Known history of adverse reaction to valacyclovir, acyclovir or famciclovir;
• Planned open label use of acyclovir, valacyclovir, or famciclovir
• Known medical history of seizures
• Known renal failure, serum creatinine >2.0mg/dl
• Hematocrit < 30 %

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Washington

Overall Clinical Trial Officials and Contacts

Connie Celum, MD, MPH Principal Investigator University of Washington  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00465205

Study ID Number: 02-3200-A-05-2

ClinicalTrials.gov Identifier: NCT00465205

Health Authority: United States: Institutional Review Board