NCT00158509

Brief Summary

Genital herpes is a long-life sexually transmitted diseases which infects a large proportion of women in Africa. Its clinical symptoms are painful sores on the genitals, which heals after a few days. HIV infection can worsen genital herpes. In turn, it is possible that genital herpes increases the quantity of HIV secreted at the genital level in women infected by the 2 viruses. This study is dedicated to verify this hypothesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
215

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2004

Shorter than P25 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

June 7, 2006

Status Verified

June 1, 2006

First QC Date

September 9, 2005

Last Update Submit

June 6, 2006

Conditions

Herpes GenitalisHIV Infection

Keywords

ValacyclovirHIV-1HSV-2genital sheddingherpes genitalisHIV infection

Outcome Measures

Primary Outcomes (1)

  • To assess the impact of HSV-2 suppressive therapy on HIV shedding among co-infected women taking highly active antiretroviral therapy (HAART) or not needing HAART

Secondary Outcomes (1)

  • To assess the impact of HSV-2 suppressive therapy on HSV-2 shedding among co-infected women taking HAART or not needing HAART

Interventions

ValacyclovirDRUG

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Infection with HIV-1 and HSV-2
  • If required to take antiretrovirals according to WHO recommendations, should be on HAART for at least 4 months
  • Written informed consent

You may not qualify if:

  • Pregnancy or willing to be pregnant during the next 6 months
  • Breastfeeding
  • Renal failure
  • Expected non-compliance with follow-up or study treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Hygiene du Centre Muraz

Bobo-Dioulasso, Burkina Faso

Location

Related Publications (4)

  • Nagot N, Foulongne V, Becquart P, Mayaud P, Konate I, Ouedraogo A, Defer MC, Weiss H, Van de Perre P, Segondy M. Longitudinal assessment of HIV-1 and HSV-2 shedding in the genital tract of West African women. J Acquir Immune Defic Syndr. 2005 Aug 15;39(5):632-4.

    PMID: 16044019RESULT

  • Mayaud P, Nagot N, Konate I, Ouedraogo A, Weiss HA, Foulongne V, Defer MC, Sawadogo A, Segondy M, Van de Perre P; ANRS 1285 Study Group. Effect of HIV-1 and antiretroviral therapy on herpes simplex virus type 2: a prospective study in African women. Sex Transm Infect. 2008 Oct;84(5):332-7. doi: 10.1136/sti.2008.030692. Epub 2008 Jul 2.

    PMID: 18596069DERIVED

  • Nagot N, Ouedraogo A, Konate I, Weiss HA, Foulongne V, Defer MC, Sanon A, Becquart P, Segondy M, Sawadogo A, Van de Perre P, Mayaud P; ANRS 1285 Study Group. Roles of clinical and subclinical reactivated herpes simplex virus type 2 infection and human immunodeficiency virus type 1 (HIV-1)-induced immunosuppression on genital and plasma HIV-1 levels. J Infect Dis. 2008 Jul 15;198(2):241-9. doi: 10.1086/589621.

    PMID: 18593294DERIVED

  • Nagot N, Ouedraogo A, Foulongne V, Konate I, Weiss HA, Vergne L, Defer MC, Djagbare D, Sanon A, Andonaba JB, Becquart P, Segondy M, Vallo R, Sawadogo A, Van de Perre P, Mayaud P; ANRS 1285 Study Group. Reduction of HIV-1 RNA levels with therapy to suppress herpes simplex virus. N Engl J Med. 2007 Feb 22;356(8):790-9. doi: 10.1056/NEJMoa062607.

    PMID: 17314338DERIVED

MeSH Terms

Conditions

Herpes GenitalisHIV Infections

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Sexually 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 DiseasesBlood-Borne InfectionsLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Nicolas Nagot

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Philippe Mayaud

    London School of Hygiene and Tropical Medicine

    STUDY CHAIR

  • Philippe Van de Perre

    Montpellier University, France

    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 9, 2005

First Posted

September 12, 2005

Study Start

August 1, 2004

Study Completion

July 1, 2005

Last Updated

June 7, 2006

Record last verified: 2006-06

Locations

BU(1)