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

NCT ID: NCT00946556

Last Updated: 2012-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-05-31

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.

Conditions

Herpes Simplex Type Two Infection; HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Valacyclovir

Intervention Type: DRUG

1g po od for 2 months

Placebo

Intervention Type: DRUG

Placebo po od for 2 months

Valacyclovir

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

Group Type: EXPERIMENTAL

Valacyclovir

Intervention Type: DRUG

1g po od for 2 months

Placebo

Intervention Type: DRUG

Placebo po od for 2 months

Interventions

Valacyclovir

1g po od for 2 months

Intervention Type: DRUG

Placebo

Placebo po od for 2 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Female
• HSV2 infected

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Rupert Kaul

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rupert Kaul, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

Women's Health In Women's Hands

Toronto, Ontario, Canada

Countries

Canada

References

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. doi: 10.1097/QAD.0b013e328012b896.

Reference Type: BACKGROUND

PMID: 17314521 (View on PubMed)

Yi TJ, Shannon B, Chieza L, Su D, Saunders M, Tharao W, Huibner S, Remis R, Raboud J, Kaul R. Valacyclovir therapy does not reverse herpes-associated alterations in cervical immunology: a randomized, placebo-controlled crossover trial. J Infect Dis. 2014 Sep 1;210(5):708-12. doi: 10.1093/infdis/jiu163. Epub 2014 Mar 23.

Reference Type: DERIVED

PMID: 24664172 (View on PubMed)

Other Identifiers

HET-85518

Identifier Type: -

Identifier Source: org_study_id