Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix
Information source: University of Toronto
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Simplex Type Two Infection; HIV Infections
Intervention: Valacyclovir (Drug); Placebo (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: University of Toronto Official(s) and/or principal investigator(s):
Rupert Kaul, MD/PhD, Principal Investigator, Affiliation: University of Toronto
Overall contact:
Lisungu Chieza, Phone: 416-263-4912, Email: lisungu@whiwh.com
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.
Clinical Details
Official title: Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix.
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment
Primary outcome: Number of CD4+ T cells on a cervical cytobrush.
Secondary outcome: Number of immature dendritic cells on a cervical cytobrushProinflammatory cytokine/chemokine levels in cervicovaginal secretions
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Female
- HSV2 infected
Exclusion Criteria:
- HIV infected
- Pregnant
- Taking HSV2 therapy
- Current/recent (past 3 months) genital infection
Locations and Contacts
Lisungu Chieza, Phone: 416-263-4912, Email: lisungu@whiwh.com
Women's Health In Women's Hands, Toronto, Ontario, Canada
Additional Information
Related publications: 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.
Starting date: September 2009
Ending date: March 2011
Last updated: August 14, 2009
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