VALIDATE: Effect of Valacyclovir in people with HIV and HSV-2 coinfectio

Phase 1

• Conditions: Coinfection of Human Immunodeficiency Virus and Herpes Simplex Virus type 2; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-002268-26-GB
• Lead Sponsor: niversity Health Network, Toronto General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-11-28
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 480

Inclusion Criteria

-adult (aged 18 years or older or as per Local/Provincial Guidelines)
-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
-antiretroviral naïve (no more than 14 days of total prior ARV exposure)
-CD4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive occasions, with at least one measurement within 4 weeks of initiating trial (baseline visit)
-does not meet recommendations for initiating ARV therapy according to current guidelines

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

-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 a therapeutic HIV vaccine or immunotherapy trial
-Enrolled in another trial investigating the impact of another intervention on HIV disease progression
-HIV elite controller (EC), phenotypically defined here as documented duration of HIV infection of =5 years, a persistent CD4 cell count =500 cells/mm3, and a persistent plasma HIV viral load of <1000 copies/mL in the absence of antiretroviral therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified