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Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals?

NCT00860977 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 202

Last updated 2018-03-06

No results posted yet for this study

Summary

This study is a multicentre, randomized, placebo-controlled, fully blinded, clinical trial of twice daily oral valacyclovir 500mg versus placebo with the goal of delaying the need for initiating HAART among HIV infected individuals who neither use nor require HAART, and who have not used chronic suppressive anti-HSV therapy for at least the 6 months prior to study initiation.

Conditions

  • HIV Infection
  • Herpes Simplex Type II
  • HIV Infections

Interventions

DRUG

valacyclovir

oral valacyclovir 500mg twice daily

DRUG

Placebo

Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily

Sponsors & Collaborators

  • CIHR Canadian HIV Trials Network

    collaborator NETWORK

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Argentina
  • Brazil
  • Canada
  • United Kingdom

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 NCT00860977 on ClinicalTrials.gov