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HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons

Primary Purpose

HIV Infections, Herpes Simplex, Sexually Transmitted Diseases

Status
Completed
Phase
Phase 3
Locations
Peru
Study Type
Interventional
Intervention
Valacyclovir
Matching Placebo
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV infection, HIV Shedding, HSV suppression, Co-infected, Women, Reactivation, Valacyclovir, Treatment Naive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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 %

Sites / Locations

  • Asociacion Civil Impacta Salud y Educacion

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

I

Arm Description

Outcomes

Primary Outcome Measures

Plasma HIV-1 levels and HIV-1 mucosal shedding

Secondary Outcome Measures

Mucosal HSV-2 shedding
Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation;

Full Information

First Posted
April 23, 2007
Last Updated
August 21, 2013
Sponsor
University of Washington
Collaborators
GlaxoSmithKline, Asociación Civil Impacta Salud y Educación, Peru
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1. Study Identification

Unique Protocol Identification Number
NCT00465205
Brief Title
HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Washington
Collaborators
GlaxoSmithKline, Asociación Civil Impacta Salud y Educación, Peru

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Herpes Simplex, Sexually Transmitted Diseases
Keywords
HIV infection, HIV Shedding, HSV suppression, Co-infected, Women, Reactivation, Valacyclovir, Treatment Naive

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Valacyclovir
Other Intervention Name(s)
Valtrex
Intervention Description
500mg oral twice daily
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Other Intervention Name(s)
Placebo for Valacyclovir
Intervention Description
500 mg oral twice daily
Primary Outcome Measure Information:
Title
Plasma HIV-1 levels and HIV-1 mucosal shedding
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Mucosal HSV-2 shedding
Time Frame
18 weeks
Title
Determine the temporal pattern of HIV shedding with respect to HSV-1 and HSV-2 reactivation;
Time Frame
18 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 %
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Celum, MD, MPH
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociacion Civil Impacta Salud y Educacion
City
Lima
Country
Peru

12. IPD Sharing Statement

Citations:
PubMed Identifier
18928378
Citation
Baeten JM, Strick LB, Lucchetti A, Whittington WL, Sanchez J, Coombs RW, Magaret A, Wald A, Corey L, Celum C. Herpes simplex virus (HSV)-suppressive therapy decreases plasma and genital HIV-1 levels in HSV-2/HIV-1 coinfected women: a randomized, placebo-controlled, cross-over trial. J Infect Dis. 2008 Dec 15;198(12):1804-8. doi: 10.1086/593214.
Results Reference
derived

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HSV-2 Suppression to Reduce HIV-1 Levels in HIV-1 Co-infected Persons

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