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

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

This study is currently recruiting participants.

Verified by University of Toronto, April 2010

First Received: July 23, 2009   Last Updated: April 14, 2010   History of Changes

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

Control: Placebo Control

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.


Resource links provided by NLM:


MedlinePlus related topics: AIDS Herpes Simplex

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources


Further study details as provided by University of Toronto:


Primary Outcome Measures:

Number of CD4+ T cells on a cervical cytobrush. [ Time Frame: Monthly intervals for 5 months ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

Number of immature dendritic cells on a cervical cytobrush [ Time Frame: Monthly intervals for 5 months ] [ Designated as safety issue: No ]

Proinflammatory cytokine/chemokine levels in cervicovaginal secretions [ Time Frame: Monthly intervals for 5 months ] [ Designated as safety issue: No ]


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: 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 for 2 months

Drug: Placebo

Placebo po od for 2 months

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 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

Criteria

Inclusion Criteria:

Female

HSV2 infected

Exclusion Criteria:

HIV infected

Pregnant

Taking HSV2 therapy

Current/recent (past 3 months) genital infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946556


Contacts

Contact: Lisungu Chieza

416-263-4912

lisungu@whiwh.com

Contact: Rupert Kaul

416-978-8607

rupert.kaul@utoronto.ca


Locations

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

Sponsors and Collaborators

University of Toronto

Investigators

Principal Investigator:

Rupert Kaul, MD/PhD

University of Toronto

More Information


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.


Responsible Party:

University of Toronto ( Rupert Kaul )

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


Keywords provided by University of Toronto:

herpes simplex virus type 2

HIV

genital immunology

CD4+ T cell

valacyclovir

HIV seronegativity


Additional relevant MeSH terms:

Herpes Simplex

Anti-Infective Agents

RNA Virus Infections

Sexually Transmitted Diseases, Viral

Slow Virus Diseases

Skin Diseases

Immune System Diseases

Acquired Immunodeficiency Syndrome

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


ClinicalTrials.gov processed this record on June 15, 2010 Examining the Ability of Herpes Simplex Virus Type 2 (HSV2) Therapy to Reduce HIV Target Cell Numbers in the Cervix

This study is currently recruiting participants.

Verified by University of Toronto, April 2010

First Received: July 23, 2009   Last Updated: April 14, 2010   History of Changes

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

Control: Placebo Control

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.


Resource links provided by NLM:


MedlinePlus related topics: AIDS Herpes Simplex

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources


Further study details as provided by University of Toronto:


Primary Outcome Measures:

Number of CD4+ T cells on a cervical cytobrush. [ Time Frame: Monthly intervals for 5 months ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

Number of immature dendritic cells on a cervical cytobrush [ Time Frame: Monthly intervals for 5 months ] [ Designated as safety issue: No ]

Proinflammatory cytokine/chemokine levels in cervicovaginal secretions [ Time Frame: Monthly intervals for 5 months ] [ Designated as safety issue: No ]


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: 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 for 2 months

Drug: Placebo

Placebo po od for 2 months

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 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

Criteria

Inclusion Criteria:

Female

HSV2 infected

Exclusion Criteria:

HIV infected

Pregnant

Taking HSV2 therapy

Current/recent (past 3 months) genital infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00946556


Contacts

Contact: Lisungu Chieza

416-263-4912

lisungu@whiwh.com

Contact: Rupert Kaul

416-978-8607

rupert.kaul@utoronto.ca


Locations

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

Sponsors and Collaborators

University of Toronto

Investigators

Principal Investigator:

Rupert Kaul, MD/PhD

University of Toronto

More Information


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.


Responsible Party:

University of Toronto ( Rupert Kaul )

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


Keywords provided by University of Toronto:

herpes simplex virus type 2

HIV

genital immunology

CD4+ T cell

valacyclovir

HIV seronegativity


Additional relevant MeSH terms:

Herpes Simplex

Anti-Infective Agents

RNA Virus Infections

Sexually Transmitted Diseases, Viral

Slow Virus Diseases

Skin Diseases

Immune System Diseases

Acquired Immunodeficiency Syndrome

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


ClinicalTrials.gov processed this record on June 15, 2010