NCT01176409

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2010

Completed
26 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

2.9 years

First QC Date

August 4, 2010

Last Update Submit

May 10, 2016

Conditions

Human Immunodeficiency VirusHerpes Simplex

Outcome Measures

Primary Outcomes (1)

  • Percentage activated CD8+ T-cells

    Percentage of CD8+ T-cells co-expressing CD38 and HLA-DR

    12 weeks

Secondary Outcomes (6)

  • Inflammatory markers

    12 weeks

  • CD4 cell count

    12 weeks

  • Virologic blips

    12 weeks

  • Drug-related adverse events

    18 weeks

  • HSV reactivations

    12 weeks

  • +1 more secondary outcomes

Study Arms (3)

High dose valacyclovir

EXPERIMENTAL

Valacyclovir 1g po BID

Drug: Valacyclovir

Low dose valacyclovir

ACTIVE COMPARATOR

Valacyclovir 500mg po BID

Drug: Valacyclovir

Placebo

PLACEBO COMPARATOR

Inert placebo

Drug: Placebo

Interventions

ValacyclovirDRUG

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.

Also known as: Apo-Valacycyclovir, Valtrex
High dose valacyclovirLow dose valacyclovir
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2N2, Canada

Location

Related Publications (1)

  • Yi TJ, Walmsley S, Szadkowski L, Raboud J, Rajwans N, Shannon B, Kumar S, Kain KC, Kaul R, Tan DH. A randomized controlled pilot trial of valacyclovir for attenuating inflammation and immune activation in HIV/herpes simplex virus 2-coinfected adults on suppressive antiretroviral therapy. Clin Infect Dis. 2013 Nov;57(9):1331-8. doi: 10.1093/cid/cit539. Epub 2013 Aug 14.

    PMID: 23946220RESULT

Related Links

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHerpes Simplex

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHerpesviridae InfectionsDNA Virus InfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Darrell HS Tan, MD FRCPC

    University Health Network, University of Toronto

    PRINCIPAL INVESTIGATOR

  • Sharon L Walmsley, MD FRCPC MSc

    University Health Network, University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2010

First Posted

August 6, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

CA(1)