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

University of Toronto

Status: Completed

Conditions: Herpes Simplex Type Two Infection; HIV Infections

Treatments: Drug: Valacyclovir; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00946556

HET-85518

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female
• HSV2 infected

Exclusion criteria

• HIV infected
• Pregnant
• Taking HSV2 therapy
• Current/recent (past 3 months) genital infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Valacyclovir

Drug: Placebo

Valacyclovir

Experimental group

Description:

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

Treatment:

Drug: Valacyclovir

Drug: Placebo