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

NCT01176409 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-05-12

No results posted yet for this study

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.

Conditions

  • Human Immunodeficiency Virus
  • Herpes Simplex

Interventions

DRUG

Valacyclovir

Valacyclovir will be used at two different dosages (1g po BID and 500mg po BID) to be used for 12 weeks. Supplied as 500mg caplets.

DRUG

Placebo

Placebo, supplied as caplets identical in appearance, odour and taste to valacyclovir 500mg caplets.

Sponsors & Collaborators

  • University of Toronto

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Darrell HS Tan, MD FRCPC · University Health Network, University of Toronto

  • Sharon L Walmsley, MD FRCPC MSc · University Health Network, University of Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-08-31
Completion
2013-08-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01176409 on ClinicalTrials.gov