NCT00158483

Brief Summary

Herpes virus type 2 (HSV-2) infection - as a cofactor of human immunodeficiency virus (HIV) transmission - can be targeted by anti-herpetic specific drugs, either as a continuous prophylactic treatment during its asymptomatic shedding phase, or as an episodic treatment during clinically-apparent genital ulcerations. The main objective of this trial will be to demonstrate that acyclovir treatment given during clinical episodes (primary infection or recurrences) can reduce genital shedding of HIV, thereby contributing to a reduction of HIV infectiousness of dually infected individuals (HIV+/HSV+).

Trial Health

90
On Track

Trial Health Score

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

Enrollment
449

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2003

Geographic Reach
2 countries

3 active sites

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

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

December 30, 2008

Status Verified

December 1, 2008

First QC Date

September 8, 2005

Last Update Submit

December 29, 2008

Conditions

UlcerHerpes Genitalis

Keywords

Genital herpesCofactors of sexual transmissionSyndromic treatmentGenital viral loadUlcer

Outcome Measures

Primary Outcomes (2)

  • Difference of HIV-1 RNA and DNA shedding assessed by performing cervicovaginal lavage (CVL) HIV viral load, among groups

  • Difference of HSV-2 DNA shedding among groups

Interventions

Acyclovir (ACV)DRUG

Eligibility Criteria

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

You may qualify if:

  • Clinically confirmed ulcer
  • Resident of city or planning to stay for 1 month
  • Be a women

You may not qualify if:

  • Pregnant women
  • Menstruating women
  • Positive protein urine test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Centre MST/SIDA

Bangui, Central African Republic

Location

WAPTCAS

Accra, Ghana

Location

Kumasi Hospital, Service d'infectiologie

Kumasi, Ghana

Location

Related Publications (3)

  • Legoff J, Bouhlal H, Gresenguet G, Weiss H, Khonde N, Hocini H, Desire N, Si-Mohamed A, de Dieu Longo J, Chemin C, Frost E, Pepin J, Malkin JE, Mayaud P, Belec L. Real-time PCR quantification of genital shedding of herpes simplex virus (HSV) and human immunodeficiency virus (HIV) in women coinfected with HSV and HIV. J Clin Microbiol. 2006 Feb;44(2):423-32. doi: 10.1128/JCM.44.2.423-432.2006.

    PMID: 16455895BACKGROUND

  • LeGoff J, Mayaud P, Gresenguet G, Weiss HA, Nzambi K, Frost E, Pepin J, Belec L; ANRS 12-12 Study Group. Performance of HerpeSelect and Kalon assays in detection of antibodies to herpes simplex virus type 2. J Clin Microbiol. 2008 Jun;46(6):1914-8. doi: 10.1128/JCM.02332-07. Epub 2008 Apr 2.

    PMID: 18385443BACKGROUND

  • Mayaud P, Legoff J, Weiss HA, Gresenguet G, Nzambi K, Bouhlal H, Frost E, Pepin J, Malkin JE, Hayes RJ, Mabey DC, Belec L; ANRS 1212 Study Group. Impact of acyclovir on genital and plasma HIV-1 RNA, genital herpes simplex virus type 2 DNA, and ulcer healing among HIV-1-infected African women with herpes ulcers: a randomized placebo-controlled trial. J Infect Dis. 2009 Jul 15;200(2):216-26. doi: 10.1086/599991.

    PMID: 19530940DERIVED

MeSH Terms

Conditions

UlcerHerpes Genitalis

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsHerpes SimplexHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Laurent Belec

    HEGP, Paris

    STUDY CHAIR

  • Gérard Grésenguet

    Faculté de Médecine Université de Bangui

    PRINCIPAL INVESTIGATOR

  • Philippe Mayaud

    London School of Hygiene and Tropical Medecine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

May 1, 2003

Study Completion

October 1, 2005

Last Updated

December 30, 2008

Record last verified: 2008-12

Locations

CE(1)GH(2)