NCT00465205

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Jan 2005

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

Study Start

First participant enrolled

January 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

Enrollment Period

11 months

First QC Date

April 23, 2007

Last Update Submit

August 21, 2013

Conditions

HIV InfectionsHerpes SimplexSexually Transmitted Diseases

Keywords

HIV infectionHIV SheddingHSV suppressionCo-infectedWomenReactivationValacyclovirTreatment Naive

Outcome Measures

Primary Outcomes (1)

  • Plasma HIV-1 levels and HIV-1 mucosal shedding

    18 weeks

Secondary Outcomes (2)

  • Mucosal HSV-2 shedding

    18 weeks

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

    18 weeks

Study Arms (1)

I

EXPERIMENTAL
Drug: ValacyclovirDrug: Matching Placebo

Interventions

ValacyclovirDRUG

500mg oral twice daily

Also known as: Valtrex
I
Matching PlaceboDRUG

500 mg oral twice daily

Also known as: Placebo for Valacyclovir
I

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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 %

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociacion Civil Impacta Salud y Educacion

Lima, Peru

Location

Related Publications (1)

  • 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.

    PMID: 18928378DERIVED

MeSH Terms

Conditions

HIV InfectionsHerpes SimplexSexually Transmitted Diseases

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHerpesviridae InfectionsDNA Virus InfectionsSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Connie Celum, MD, MPH

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 24, 2007

Study Start

January 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2007

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations

PE(1)