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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: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Examining the Ability of HSV2 Therapy to Reduce HIV Target Cell Numbers in the Cervix. |
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | September 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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 | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Lisungu Chieza 416-263-4912 lisungu@whiwh.com | |
| Contact: Wangari Tharao 146-263-4870 wangari@whiwh.com | |
| Principal Investigator: Wangari Tharao | |
| Principal Investigator: | Rupert Kaul, MD/PhD | University of Toronto |
More Information
| Responsible Party: | Rupert Kaul, University of Toronto |
| ClinicalTrials.gov Identifier: | NCT00946556 History of Changes |
| Other Study ID Numbers: | HET-85518 |
| Study First Received: | July 23, 2009 |
| Last Updated: | April 14, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
|
herpes simplex virus type 2 HIV genital immunology |
CD4+ T cell valacyclovir HIV seronegativity |
|
HIV Infections Acquired Immunodeficiency Syndrome Herpes Simplex Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Herpesviridae Infections DNA Virus Infections Skin Diseases, Viral Skin Diseases, Infectious Skin Diseases Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
