Clinical Trials For Genital Herpes Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals With Herpes Simplex Virus Type 2? (VALIDATE)

Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals With Herpes Simplex Virus Type 2? (VALIDATE)

This study is currently recruiting participants.

Verified by University Health Network, Toronto, March 2010

First Received: March 11, 2009   Last Updated: March 5, 2010   History of Changes

Sponsor:

University Health Network, Toronto

Information provided by:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00860977

Purpose

The purpose of this study is to determine whether medication to suppress herpes simplex virus type 2 (HSV-2) infection can slow the rate of HIV disease progression and delay the need for initiating HAART in HIV, HSV-2 co-infected individuals.


Condition

Intervention

Phase

HIV Infection

Herpesvirus 2, Human

HIV Infections

Drug: valacyclovir

Drug: Placebo

Phase III


Study Type:

Interventional

Study Design:

Allocation: Randomized

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

Official Title:

VALacyclovir In Delaying Antiretroviral Treatment Entry


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 Health Network, Toronto:


Primary Outcome Measures:

Time from baseline until reaching the primary endpoint, a composite of either a CD4 cell count ≤350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART for any reason, whichever occurs first. [ Time Frame: 5 years ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

Annual rate of change in CD4 count, calculated as the slope of patients’ CD4 count change / time [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Annual rate of change in the CD4 cell count percentage, calculated as the slope of the patient’s CD4 count percentage change over time [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Log10 plasma HIV viral load [ Time Frame: 12, 24 and 36 months of follow-up ] [ Designated as safety issue: No ]

Treatment-emergent adverse events and laboratory abnormalities [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Frequency of episodes of HSV reactivations at any anatomic site [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Proportion of microbiologically confirmed flares of HSV during the trial that are caused by laboratory-confirmed acyclovir-resistant HSV [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]


Estimated Enrollment:

480

Study Start Date:

March 2010

Estimated Study Completion Date:

February 2015

Estimated Primary Completion Date:

February 2015 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

Placebo: Placebo Comparator

Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily

Drug: Placebo

Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily

Valacyclovir: Experimental

oral valacyclovir 500mg twice daily

Drug: valacyclovir

oral valacyclovir 500mg twice daily


Detailed Description:

Highly active antiretroviral therapy (HAART) has drastically reduced the morbidity and mortality associated with HIV infection, and transformed HIV from an invariably fatal disease into a manageable, chronic condition. However, the inconvenience, high cost, potential side effects, and significant risk of developing drug-resistant HIV associated with taking daily, lifelong HAART make the potential delay of HAART initiation an extremely desirable goal for HIV-infected individuals.

Suppression of herpes simplex virus (HSV)-2 co-infection may provide a novel therapeutic strategy for achieving this goal. HSV-2 is among the most common co-infections seen in persons infected with HIV, with rates of up to 52-95%. This co-infection is associated with increased blood levels of HIV, a major predictor of HIV disease progression, even when the person has no herpes symptoms. Medications such as valacyclovir that suppress herpes can also decrease blood levels of HIV, but the potential long-term clinical benefits of this drug have not been adequately studied. It is thus hypothesized that valacyclovir could slow HIV disease progression and prolong the period of time before a co-infected person needs to initiate HAART. This research has been designed to answer this important question through a randomized, placebo-controlled, multi-centre clinical trial.

Eligibility


Ages Eligible for Study:

16 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

adult (aged 18 years or older or as per Local/Provincial Guidelines)

documented HIV-1 infection

documented HSV-2 seropositivity

no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study

antiretroviral naïve (no more than 14 days of total prior ARV exposure)

CD4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive occasions, with at least one measurement within 4 weeks of initiating trial

does not meet recommendations for initiating ARV therapy according to current guidelines

Exclusion Criteria:

pregnancy or actively planning to become pregnant

receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications

estimated creatinine clearance <30 mL/min

medical condition likely to cause death within 24 months

enrolled in a therapeutic vaccine or immunotherapy trial

enrolled in another trial investigating the impact of another intervention on HIV disease progression

HIV elite controller / long-term non-progressor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860977


Contacts

Contact: Sharon L Walmsley, MD FRCPC MSc

416-340-4800 ext 3871

sharon.walmsley@uhn.on.ca

Contact: Darrell HS Tan, MD FRCPC

416-340-4800 ext 2240

darrell.tan@gmail.com


Locations

Argentina

Fundación Huesped

Not yet recruiting

Buenos Aires, Argentina, C1202ABB

Contact: Pedro Cahn, MD     5411 49817777

Principal Investigator: Pedro Cahn, MD

Brazil

Instituto de Pesquisa Clínica Evandro Chagas

Not yet recruiting

Rio de Janeiro, Brazil

Principal Investigator: Beatriz Grinsztejn, MD PhD

Canada, Alberta

University of Alberta

Not yet recruiting

Edmonton, Alberta, Canada, T6G 2C8

Contact: Barbara Romanowski, MD     780-436-4900

Principal Investigator: Barbara Romanowski, MD

Canada, British Columbia

Downtown ID Clinic

Not yet recruiting

Vancouver, British Columbia, Canada, V6Z 2C7

Contact: Brian Conway, MD     604 642 6429

Principal Investigator: Brian Conway, MD

Cool Aid Community Health Centre

Not yet recruiting

VIctoria, British Columbia, Canada, V8W 1M8

Contact: Chris Fraser, MD     250-385-1466

Principal Investigator: Chris Fraser, MD

Canada, Nova Scotia

CDHA, QEII Health Sciences Centre

Not yet recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contact: David Haase, MD     902-473-7786

Principal Investigator: David Haase, MD

Canada, Ontario

McMaster University Health Sciences Centre

Not yet recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contact: Fiona Smaill, MD     905-521-2100 ext. 76332

Principal Investigator: Fiona Smaill, MD

The Ottawa Hospital, General Campus Divsions of Infectious Diseases

Not yet recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contact: Bill Cameron, MD     613-737-8902

Principal Investigator: Bill Cameron, MD

University of Ottawa Health Services

Not yet recruiting

Ottawa, Ontario, Canada, K1N 6N5

Contact: Don Kilby, MD     613-654-3950

Principal Investigator: Don Kilby, MD

Maple Leaf Medical Clinic

Not yet recruiting

Toronto, Ontario, Canada, M5B 1L6

Contact: Jason Brunetta     416-465-0856

Principal Investigator: Jason Brunetta, MD

St. Clair Medical Associates

Not yet recruiting

Toronto, Ontario, Canada, M4K 1N1

Contact: Ken Logue, MD     416- 966-0178

Principal Investigator: Ken Logue, MD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contact: Sharon L Walmsley, MD FRCPC     416-340-4800 ext 3871     sharon.walmsley@uhn.on.ca

Contact: Darrell HS Tan, MD FRCPC     416-340-4800 ext 2240

Sub-Investigator: Darrell HS Tan, MD FRCPC

Principal Investigator: Sharon L Walmsley, MD

Sunnybrook Health Science Centre

Not yet recruiting

Toronto, Ontario, Canada, M2N 3M5

Contact: Anita Rachlis, MD     416-480-4689

Principal Investigator: Anita Rachlis, MD

St. Michael’s Hospital

Not yet recruiting

Toronto, Ontario, Canada, M5B 1W8

Contact: Darrell Tan, MD     416-864-5568

Principal Investigator: Darrell Tan, MD

Windsor Regional Hospital

Not yet recruiting

Windsor, Ontario, Canada, N8W 1E3

Contact: Jeffery Cohen, MD     519-254-6115

Principal Investigator: Jeffery Cohen, MD

Canada, Quebec

Montreal Chest Institute

Not yet recruiting

Montreal, Quebec, Canada, H2X 2P4

Contact: Marina Klein, MD     514-843-2090

Principal Investigator: Marina Klein, MD

McGill University Health Centre

Not yet recruiting

Montreal, Quebec, Canada, H3G 1A4

Contact: Chris Tsoukas, MD     514-934-1934

Principal Investigator: Chris Tsoukas, MD

Clinique Médicale l’Actuel

Not yet recruiting

Montréal, Quebec, Canada, H2L 4P9

Contact: Benoit Trottier, MD     514-524-3250

Principal Investigator: Benoit Trottier, MD

Clinique Médicale du Quartier Latin

Not yet recruiting

Montréal, Quebec, Canada, H2L 5B1

Contact: Jean-Guy Baril, MD     514-285-2226

Principal Investigator: Jean-Guy Baril, MD

Centre Hospitalier de l’Université de Montréal

Not yet recruiting

Montréal, Quebec, Canada, H2L 4M1

Contact: Claude Fortin, MD     514 890 8000 Ext 24723

Principal Investigator: Claude Fortin, MD

Université de Sherbrooke

Not yet recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contact: Alain Piché, MD     (819) 346-1110, poste 15834

Principal Investigator: Alain Piché, MD

Canada, Saskatchewan

Royal University Hospital

Not yet recruiting

Saskatoon, Saskatchewan, Canada, S7N OW8

Contact: Kurt Williams, MD     (306) 966-7947

Principal Investigator: Kurt Williams, MD

Canada

Centre Hospitalier Universitaire de Quebec-Pavillon CHUL

Not yet recruiting

Quebec, Canada, G1V 4G2

Contact: Sylvie Trottier, MD     418-654-2705

Principal Investigator: Sylvie Trottier, MD

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Sharon L Walmsley, MD FRCPC MSc

University Health Network, Toronto

Principal Investigator:

Darrell HS Tan, MD FRCPC

University Health Network, Toronto

More Information


Additional Information:

CIHR Canadian HIV Trials Network homepage


No publications provided


Responsible Party:

CIHR Canadian HIV Trials Network ( Dr Sharon Walmsley, Dr Darrell Tan )

ClinicalTrials.gov Identifier:

NCT00860977 History of Changes

Other Study ID Numbers:

CTN-240, ISRCTN66756285

Study First Received:

March 11, 2009

Last Updated:

March 5, 2010

Health Authority:

Canada: Health Canada


Keywords provided by University Health Network, Toronto:

HIV

Herpes simplex virus type 2

Genital herpes

Treatment Naive


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

Acyclovir

HIV Infections

Therapeutic Uses

Sexually Transmitted Diseases

Lentivirus Infections

DNA Virus Infections

Retroviridae Infections


ClinicalTrials.gov processed this record on June 15, 2010 Can Valacyclovir Delay the Need for Initiation of Human Immunodeficiency Virus (HIV) Treatment in HIV-infected Individuals With Herpes Simplex Virus Type 2? (VALIDATE)

This study is currently recruiting participants.

Verified by University Health Network, Toronto, March 2010

First Received: March 11, 2009   Last Updated: March 5, 2010   History of Changes

Sponsor:

University Health Network, Toronto

Information provided by:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00860977

Purpose

The purpose of this study is to determine whether medication to suppress herpes simplex virus type 2 (HSV-2) infection can slow the rate of HIV disease progression and delay the need for initiating HAART in HIV, HSV-2 co-infected individuals.


Condition

Intervention

Phase

HIV Infection

Herpesvirus 2, Human

HIV Infections

Drug: valacyclovir

Drug: Placebo

Phase III


Study Type:

Interventional

Study Design:

Allocation: Randomized

Endpoint Classification: Efficacy Study

Intervention Model: Parallel Assignment

Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

Official Title:

VALacyclovir In Delaying Antiretroviral Treatment Entry


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 Health Network, Toronto:


Primary Outcome Measures:

Time from baseline until reaching the primary endpoint, a composite of either a CD4 cell count ≤350 cells/mm3 measured on two consecutive occasions at least 1 month apart, or initiation of HAART for any reason, whichever occurs first. [ Time Frame: 5 years ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

Annual rate of change in CD4 count, calculated as the slope of patients’ CD4 count change / time [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Annual rate of change in the CD4 cell count percentage, calculated as the slope of the patient’s CD4 count percentage change over time [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Log10 plasma HIV viral load [ Time Frame: 12, 24 and 36 months of follow-up ] [ Designated as safety issue: No ]

Treatment-emergent adverse events and laboratory abnormalities [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Frequency of episodes of HSV reactivations at any anatomic site [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Proportion of microbiologically confirmed flares of HSV during the trial that are caused by laboratory-confirmed acyclovir-resistant HSV [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]


Estimated Enrollment:

480

Study Start Date:

March 2010

Estimated Study Completion Date:

February 2015

Estimated Primary Completion Date:

February 2015 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

Placebo: Placebo Comparator

Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily

Drug: Placebo

Odourless placebo tablet identical to valacyclovir in appearance and taste, to be taken twice daily

Valacyclovir: Experimental

oral valacyclovir 500mg twice daily

Drug: valacyclovir

oral valacyclovir 500mg twice daily


Detailed Description:

Highly active antiretroviral therapy (HAART) has drastically reduced the morbidity and mortality associated with HIV infection, and transformed HIV from an invariably fatal disease into a manageable, chronic condition. However, the inconvenience, high cost, potential side effects, and significant risk of developing drug-resistant HIV associated with taking daily, lifelong HAART make the potential delay of HAART initiation an extremely desirable goal for HIV-infected individuals.

Suppression of herpes simplex virus (HSV)-2 co-infection may provide a novel therapeutic strategy for achieving this goal. HSV-2 is among the most common co-infections seen in persons infected with HIV, with rates of up to 52-95%. This co-infection is associated with increased blood levels of HIV, a major predictor of HIV disease progression, even when the person has no herpes symptoms. Medications such as valacyclovir that suppress herpes can also decrease blood levels of HIV, but the potential long-term clinical benefits of this drug have not been adequately studied. It is thus hypothesized that valacyclovir could slow HIV disease progression and prolong the period of time before a co-infected person needs to initiate HAART. This research has been designed to answer this important question through a randomized, placebo-controlled, multi-centre clinical trial.

Eligibility


Ages Eligible for Study:

16 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

adult (aged 18 years or older or as per Local/Provincial Guidelines)

documented HIV-1 infection

documented HSV-2 seropositivity

no use of chronic anti-HSV therapy for the past 6 months, and not anticipated to require chronic anti-HSV therapy during the study

antiretroviral naïve (no more than 14 days of total prior ARV exposure)

CD4 count within the 400-900 cells/mm3 range (inclusive) on two consecutive occasions, with at least one measurement within 4 weeks of initiating trial

does not meet recommendations for initiating ARV therapy according to current guidelines

Exclusion Criteria:

pregnancy or actively planning to become pregnant

receiving chemotherapy, chronic steroid therapy or other immunomodulatory medications

estimated creatinine clearance <30 mL/min

medical condition likely to cause death within 24 months

enrolled in a therapeutic vaccine or immunotherapy trial

enrolled in another trial investigating the impact of another intervention on HIV disease progression

HIV elite controller / long-term non-progressor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860977


Contacts

Contact: Sharon L Walmsley, MD FRCPC MSc

416-340-4800 ext 3871

sharon.walmsley@uhn.on.ca

Contact: Darrell HS Tan, MD FRCPC

416-340-4800 ext 2240

darrell.tan@gmail.com


Locations

Argentina

Fundación Huesped

Not yet recruiting

Buenos Aires, Argentina, C1202ABB

Contact: Pedro Cahn, MD     5411 49817777

Principal Investigator: Pedro Cahn, MD

Brazil

Instituto de Pesquisa Clínica Evandro Chagas

Not yet recruiting

Rio de Janeiro, Brazil

Principal Investigator: Beatriz Grinsztejn, MD PhD

Canada, Alberta

University of Alberta

Not yet recruiting

Edmonton, Alberta, Canada, T6G 2C8

Contact: Barbara Romanowski, MD     780-436-4900

Principal Investigator: Barbara Romanowski, MD

Canada, British Columbia

Downtown ID Clinic

Not yet recruiting

Vancouver, British Columbia, Canada, V6Z 2C7

Contact: Brian Conway, MD     604 642 6429

Principal Investigator: Brian Conway, MD

Cool Aid Community Health Centre

Not yet recruiting

VIctoria, British Columbia, Canada, V8W 1M8

Contact: Chris Fraser, MD     250-385-1466

Principal Investigator: Chris Fraser, MD

Canada, Nova Scotia

CDHA, QEII Health Sciences Centre

Not yet recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contact: David Haase, MD     902-473-7786

Principal Investigator: David Haase, MD

Canada, Ontario

McMaster University Health Sciences Centre

Not yet recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contact: Fiona Smaill, MD     905-521-2100 ext. 76332

Principal Investigator: Fiona Smaill, MD

The Ottawa Hospital, General Campus Divsions of Infectious Diseases

Not yet recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contact: Bill Cameron, MD     613-737-8902

Principal Investigator: Bill Cameron, MD

University of Ottawa Health Services

Not yet recruiting

Ottawa, Ontario, Canada, K1N 6N5

Contact: Don Kilby, MD     613-654-3950

Principal Investigator: Don Kilby, MD

Maple Leaf Medical Clinic

Not yet recruiting

Toronto, Ontario, Canada, M5B 1L6

Contact: Jason Brunetta     416-465-0856

Principal Investigator: Jason Brunetta, MD

St. Clair Medical Associates

Not yet recruiting

Toronto, Ontario, Canada, M4K 1N1

Contact: Ken Logue, MD     416- 966-0178

Principal Investigator: Ken Logue, MD

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2N2

Contact: Sharon L Walmsley, MD FRCPC     416-340-4800 ext 3871     sharon.walmsley@uhn.on.ca

Contact: Darrell HS Tan, MD FRCPC     416-340-4800 ext 2240

Sub-Investigator: Darrell HS Tan, MD FRCPC

Principal Investigator: Sharon L Walmsley, MD

Sunnybrook Health Science Centre

Not yet recruiting

Toronto, Ontario, Canada, M2N 3M5

Contact: Anita Rachlis, MD     416-480-4689

Principal Investigator: Anita Rachlis, MD

St. Michael’s Hospital

Not yet recruiting

Toronto, Ontario, Canada, M5B 1W8

Contact: Darrell Tan, MD     416-864-5568

Principal Investigator: Darrell Tan, MD

Windsor Regional Hospital

Not yet recruiting

Windsor, Ontario, Canada, N8W 1E3

Contact: Jeffery Cohen, MD     519-254-6115

Principal Investigator: Jeffery Cohen, MD

Canada, Quebec

Montreal Chest Institute

Not yet recruiting

Montreal, Quebec, Canada, H2X 2P4

Contact: Marina Klein, MD     514-843-2090

Principal Investigator: Marina Klein, MD

McGill University Health Centre

Not yet recruiting

Montreal, Quebec, Canada, H3G 1A4

Contact: Chris Tsoukas, MD     514-934-1934

Principal Investigator: Chris Tsoukas, MD

Clinique Médicale l’Actuel

Not yet recruiting

Montréal, Quebec, Canada, H2L 4P9

Contact: Benoit Trottier, MD     514-524-3250

Principal Investigator: Benoit Trottier, MD

Clinique Médicale du Quartier Latin

Not yet recruiting

Montréal, Quebec, Canada, H2L 5B1

Contact: Jean-Guy Baril, MD     514-285-2226

Principal Investigator: Jean-Guy Baril, MD

Centre Hospitalier de l’Université de Montréal

Not yet recruiting

Montréal, Quebec, Canada, H2L 4M1

Contact: Claude Fortin, MD     514 890 8000 Ext 24723

Principal Investigator: Claude Fortin, MD

Université de Sherbrooke

Not yet recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contact: Alain Piché, MD     (819) 346-1110, poste 15834

Principal Investigator: Alain Piché, MD

Canada, Saskatchewan

Royal University Hospital

Not yet recruiting

Saskatoon, Saskatchewan, Canada, S7N OW8

Contact: Kurt Williams, MD     (306) 966-7947

Principal Investigator: Kurt Williams, MD

Canada

Centre Hospitalier Universitaire de Quebec-Pavillon CHUL

Not yet recruiting

Quebec, Canada, G1V 4G2

Contact: Sylvie Trottier, MD     418-654-2705

Principal Investigator: Sylvie Trottier, MD

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Sharon L Walmsley, MD FRCPC MSc

University Health Network, Toronto

Principal Investigator:

Darrell HS Tan, MD FRCPC

University Health Network, Toronto

More Information


Additional Information:

CIHR Canadian HIV Trials Network homepage


No publications provided


Responsible Party:

CIHR Canadian HIV Trials Network ( Dr Sharon Walmsley, Dr Darrell Tan )

ClinicalTrials.gov Identifier:

NCT00860977 History of Changes

Other Study ID Numbers:

CTN-240, ISRCTN66756285

Study First Received:

March 11, 2009

Last Updated:

March 5, 2010

Health Authority:

Canada: Health Canada


Keywords provided by University Health Network, Toronto:

HIV

Herpes simplex virus type 2

Genital herpes

Treatment Naive


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

Acyclovir

HIV Infections

Therapeutic Uses

Sexually Transmitted Diseases

Lentivirus Infections

DNA Virus Infections

Retroviridae Infections


ClinicalTrials.gov processed this record on June 15, 2010