NCT00378976

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 that HSV is an important cofactor in HIV transmission. The trial's purpose is to assess the reduction in HIV shedding associated with valacyclovir for suppression of HSV-2 reactivation. This proof-of-concept, randomized, double-blind, placebo controlled crossover trial of 20 HIV/HSV-2 co-infected men, assessed the effects of daily valacyclovir on HIV-1 levels in the plasma and rectal mucosa secretions.

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

Timeline
Completed

Started Aug 2003

Shorter than P25 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

Study Start

First participant enrolled

August 1, 2003

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
Last Updated

August 22, 2013

Status Verified

August 1, 2013

First QC Date

September 19, 2006

Last Update Submit

August 21, 2013

Conditions

HIV InfectionHerpes SimplexSexually Transmitted Diseases

Keywords

HIV infectionHIV sheddingHSV suppressionCo-infectedMSMReactivationValacyclovir

Outcome Measures

Primary Outcomes (1)

  • Reduction in anogenital HIV-1 shedding with suppression of HSV-2 reactivation.

    18 weeks

Secondary Outcomes (3)

  • Evaluate HSV-2 suppression with decreased plasma HIV RNA levels

    18 weeks

  • Assess the effect of daily valacyclovir on pharyngeal shedding in HSV-1 seropositive individuals

    18 weeks

  • Determine the temporal pattern of HIV shedding in the rectum, pharynx and semen with respect to mucosal HSV-1 and HSV-2 reactivation; Determine HSV-2 suppression and HIV replication within rectal mucosa.

    18 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: valacyclovir

2

PLACEBO COMPARATOR
Drug: matching placebo

Interventions

valacyclovirDRUG

500 mg twice-daily oral

1
matching placeboDRUG

twice daily as per experimental drug

2

Eligibility Criteria

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

You may qualify if:

  • Greater than 18 years old,
  • 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:

  • MSM 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 (2)

  • Zuckerman RA, Lucchetti A, Whittington WL, Sanchez J, Coombs RW, Magaret A, Wald A, Corey L, Celum C. HSV suppression reduces seminal HIV-1 levels in HIV-1/HSV-2 co-infected men who have sex with men. AIDS. 2009 Feb 20;23(4):479-83. doi: 10.1097/QAD.0b013e328326ca62.

    PMID: 19169140DERIVED

  • Zuckerman RA, Lucchetti A, Whittington WL, Sanchez J, Coombs RW, Zuniga R, Magaret AS, Wald A, Corey L, Celum C. Herpes simplex virus (HSV) suppression with valacyclovir reduces rectal and blood plasma HIV-1 levels in HIV-1/HSV-2-seropositive men: a randomized, double-blind, placebo-controlled crossover trial. J Infect Dis. 2007 Nov 15;196(10):1500-8. doi: 10.1086/522523. Epub 2007 Oct 31.

    PMID: 18008230DERIVED

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

September 19, 2006

First Posted

September 21, 2006

Study Start

August 1, 2003

Study Completion

July 1, 2004

Last Updated

August 22, 2013

Record last verified: 2013-08

Locations

PE(1)