Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix

HIV Infections Clinical Trial

Official title:

Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946556
• Other study ID #: HET-85518
• Status: Completed
• Phase: N/A
• First received: July 23, 2009
• Last updated: March 21, 2012
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: March 2012
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Herpes simplex virus type 2 (HSV2), the most common cause of genital herpes, increases a woman's risk of HIV acquisition from 3-6 fold, perhaps because HSV2-infected women have increased numbers of HIV "target cells" (CD4 T cells and dendritic cells) in the cervical mucosa. However, recent clinical trials showed no impact of HSV2 suppression on HIV acquisition rates. The reasons for this negative result are unclear. The investigators propose to examine the effect of valacyclovir (a widely used herpes medication) treatment on cervical immunology and HIV target cells in the cervix. The study will take the form of a randomized, double-blind, placebo-controlled crossover trial. Primary endpoints will be (1) the number of CD4 T cells on a cervical cytobrush and (2) the number of immature dendritic cells per cervical cytobrush.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female

• HSV2 infected

Exclusion Criteria:

• HIV infected

• Pregnant

• Taking HSV2 therapy

• Current/recent (past 3 months) genital infection

Related Conditions & MeSH terms

• Communicable Diseases
• Herpes Simplex
• Herpes Simplex Type Two Infection
• HIV Infections
• Infection

Intervention

Drug:
• Valacyclovir
1g po od for 2 months
• Placebo
Placebo po od for 2 months

Locations

Country	Name	City	State
Canada	Women's Health In Women's Hands	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Rebbapragada A, Wachihi C, Pettengell C, Sunderji S, Huibner S, Jaoko W, Ball B, Fowke K, Mazzulli T, Plummer FA, Kaul R. Negative mucosal synergy between Herpes simplex type 2 and HIV in the female genital tract. AIDS. 2007 Mar 12;21(5):589-98. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CD4+ T cells on a cervical cytobrush.		Monthly intervals for 5 months
Secondary	Number of immature dendritic cells on a cervical cytobrush		Monthly intervals for 5 months
Secondary	Proinflammatory cytokine/chemokine levels in cervicovaginal secretions		Monthly intervals for 5 months