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

Sponsor

University of Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00946556

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Herpes Simplex Type Two Infection HIV Infections	Drug: Valacyclovir Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.	Drug: Valacyclovir 1g po od for 2 months Drug: Placebo Placebo po od for 2 months
Experimental: Valacyclovir Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.	Drug: Valacyclovir 1g po od for 2 months Drug: Placebo Placebo po od for 2 months

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.

Drug: Valacyclovir

1g po od for 2 months

Drug: Placebo

Placebo po od for 2 months

Experimental: Valacyclovir

Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.

Drug: Valacyclovir

1g po od for 2 months

Drug: Placebo

Placebo po od for 2 months

Outcome Measures

Primary Outcome Measures

Number of CD4+ T cells on a cervical cytobrush. [Monthly intervals for 5 months]

Secondary Outcome Measures

Number of immature dendritic cells on a cervical cytobrush [Monthly intervals for 5 months]
Proinflammatory cytokine/chemokine levels in cervicovaginal secretions [Monthly intervals for 5 months]