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| Sponsor: | University of Toronto |
|---|---|
| Information provided by: | University of Toronto |
| ClinicalTrials.gov Identifier: | NCT00946556 |
Purpose
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 | Intervention |
|---|---|
|
Herpes Simplex Type Two Infection HIV Infections |
Drug: Valacyclovir Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment |
| Official Title: | Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix. |
| Estimated Enrollment: | 30 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo: Placebo Comparator
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
|
Drug: Valacyclovir
1g po od
Drug: Placebo
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Valacyclovir: Experimental
Participants will be assigned 2 months of placebo or active drug, with an intervening one month washout period.
|
Drug: Valacyclovir
1g po od
Drug: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lisungu Chieza | 416-263-4912 | lisungu@whiwh.com |
| Contact: Rupert Kaul | 416-978-8607 | rupert.kaul@utoronto.ca |
| Canada, Ontario | |
| Women's Health In Women's Hands | |
| Toronto, Ontario, Canada | |
| Principal Investigator: | Rupert Kaul, MD/PhD | University of Toronto |
More Information
| Responsible Party: | University of Toronto ( Rupert Kaul ) |
| Study ID Numbers: | HET-85518 |
| Study First Received: | July 23, 2009 |
| Last Updated: | August 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00946556 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
herpes simplex virus type 2 HIV genital immunology |
CD4+ T cell valacyclovir HIV seronegativity |
|
Herpes Simplex Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Skin Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Herpesviridae Infections Valacyclovir Skin Diseases, Viral Virus Diseases Skin Diseases, Infectious HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Retroviridae Infections |
