Clinical Trials For Genital Herpes Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV

Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV

This study is currently recruiting participants.

Verified by University of Washington, March 2010

First Received: September 7, 2007   Last Updated: March 16, 2010   History of Changes

Sponsor:

University of Washington

Collaborator:

GlaxoSmithKline

Information provided by:

University of Washington

ClinicalTrials.gov Identifier:

NCT00527618

Purpose

To compare the effect of daily valacyclovir 1 gram orally twice daily versus acyclovir 400 mg orally twice daily on the frequency of genital HSV reactivation and on plasma and genital HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The investigators hypothesize that both treatments will reduce genital HSV and systemic and genital HIV-1.


Condition

Intervention

Phase

Genital Herpes

HIV Infections

Drug: valacyclovir

Drug: acyclovir

Phase IV


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Active Control

Endpoint Classification: Efficacy Study

Intervention Model: Crossover Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title:

A Randomized, Open-label, Crossover Trial of the Effect of Dosing of Daily HSV-2 Suppressive Therapy on HSV Reactivation and Plasma and Genital HIV-1 Levels Among HIV-1/ HSV-2 Co-infected Persons


Resource links provided by NLM:


MedlinePlus related topics: AIDS Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources


Further study details as provided by University of Washington:


Primary Outcome Measures:

The primary endpoints are the presence and quantity of genital HSV and the level of HIV-1 RNA in plasma and genital secretions of participants while on 400 mg twice daily of acyclovir versus while on 1000 mg twice daily of valacyclovir. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

To evaluate the effect of valacyclovir 1 gram orally twice daily on prevention of days with genital herpes lesions compared with acyclovir 400 mg orally twice daily. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

To evaluate the safety of valacyclovir 1 gram orally twice daily in HIV-1 seropositive persons. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]


Estimated Enrollment:

38

Study Start Date:

December 2007

Estimated Study Completion Date:

December 2011

Estimated Primary Completion Date:

December 2011 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

1: Experimental

valacyclovir 1 gram orally twice daily

Drug: valacyclovir

1 gram orally twice daily

2: Active Comparator

acyclovir 400 mg orally twice daily

Drug: acyclovir

400 mg orally twice daily


Detailed Description:

We propose to conduct a randomized, open-label, cross-over study of 38 individuals who are HIV-1 seropositive and HSV-2 seropositive. Both men and women will be recruited for the study. Participants must not be on antiretroviral therapy and must not be planning to initiate antiretroviral therapy during the anticipated study period. Participants will be randomized 1:1 to receive acyclovir 400 mg twice daily or valacyclovir 1000 mg twice daily. After 12 weeks on the initial treatment, each participant will be crossed over to the alternative treatment arm for 12 weeks. The treatment periods will be separated by a 2-week washout period. During the first four weeks of each treatment period (i.e., Weeks 1-4 and Weeks 15-18), participants will provide self-collected genital swabs daily for HSV detection. Each week during the entire study period, participants will provide plasma and genital samples for HIV-1 detection.

Open-label acyclovir and valacyclovir will be used for this trial, as the primary outcome measures (genital HSV and plasma and genital HIV-1) are unlikely to be influenced by knowledge of treatment assignment. However, laboratory staff performing plasma and genital HIV-1 measurements will not be aware of treatment assignment.

Eligibility


Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age 18 years or older

Documented HIV-1 seropositive

Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period

Detectable HIV-1 plasma viral load

HSV-2 seropositive as determined by western blot

Not intending to move out of the area for the duration of study participation

Willing and able to provide independent written informed consent

Willing and able to undergo clinical evaluations

Willing and able to take study drug as directed

Willing and able to adhere to follow-up schedule

Exclusion Criteria:

Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir

Planned open label use of acyclovir, valacyclovir, or famciclovir

History of evidence of CMV disease

Known medical history of seizures

Known renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl

AST or ALT greater than 3 times upper limit of normal

Hematocrit less than 30 %

Neutropenia, defined as absolute neutrophil count less than 1000

Thrombocytopenia, defined as platelet count less than 75,000

History of thrombotic microangiopathy

For women, pregnancy as confirmed by a urine pregnancy test

Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527618


Contacts

Contact: Jared Baeten, MD, PhD

206-720-4340

jbaeten@u.washington.edu


Locations

United States, Washington

University of Washington Virology Research Clinic

Recruiting

Seattle, Washington, United States, 98122

Contact     206-720-4340     vrc@u.washington.edu

Sponsors and Collaborators

University of Washington

GlaxoSmithKline

Investigators

Principal Investigator:

Jared Baeten, MD, PhD

University of Washington

Study Director:

Anna Wald, MD, MPH

University of Washington

More Information


No publications provided


Responsible Party:

University of Washington ( Jared Baeten )

ClinicalTrials.gov Identifier:

NCT00527618 History of Changes

Other Study ID Numbers:

31203-D, GSK VAL111009 – VAL140

Study First Received:

September 7, 2007

Last Updated:

March 16, 2010

Health Authority:

United States: Institutional Review Board


Keywords provided by University of Washington:

Herpes Simplex Virus 2

Human Immunodeficiency Virus

Treatment Naive


Additional relevant MeSH terms:

Anti-Infective Agents

Sexually Transmitted Diseases, Viral

Slow Virus Diseases

Genital Diseases, Female

Valacyclovir

Therapeutic Uses

Retroviridae Infections

Herpes Simplex

RNA Virus Infections

Immune System Diseases

Skin Diseases

Herpes Genitalis

Acquired Immunodeficiency Syndrome

Genital Diseases, Male

Antiviral Agents

Pharmacologic Actions

Immunologic Deficiency Syndromes

Herpesviridae Infections

Virus Diseases

Skin Diseases, Viral

Skin Diseases, Infectious

Acyclovir

HIV Infections

Sexually Transmitted Diseases

Lentivirus Infections

DNA Virus Infections


ClinicalTrials.gov processed this record on June 15, 2010Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV

This study is currently recruiting participants.

Verified by University of Washington, March 2010

First Received: September 7, 2007   Last Updated: March 16, 2010   History of Changes

Sponsor:

University of Washington

Collaborator:

GlaxoSmithKline

Information provided by:

University of Washington

ClinicalTrials.gov Identifier:

NCT00527618

Purpose

To compare the effect of daily valacyclovir 1 gram orally twice daily versus acyclovir 400 mg orally twice daily on the frequency of genital HSV reactivation and on plasma and genital HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The investigators hypothesize that both treatments will reduce genital HSV and systemic and genital HIV-1.


Condition

Intervention

Phase

Genital Herpes

HIV Infections

Drug: valacyclovir

Drug: acyclovir

Phase IV


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Active Control

Endpoint Classification: Efficacy Study

Intervention Model: Crossover Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title:

A Randomized, Open-label, Crossover Trial of the Effect of Dosing of Daily HSV-2 Suppressive Therapy on HSV Reactivation and Plasma and Genital HIV-1 Levels Among HIV-1/ HSV-2 Co-infected Persons


Resource links provided by NLM:


MedlinePlus related topics: AIDS Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources


Further study details as provided by University of Washington:


Primary Outcome Measures:

The primary endpoints are the presence and quantity of genital HSV and the level of HIV-1 RNA in plasma and genital secretions of participants while on 400 mg twice daily of acyclovir versus while on 1000 mg twice daily of valacyclovir. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

To evaluate the effect of valacyclovir 1 gram orally twice daily on prevention of days with genital herpes lesions compared with acyclovir 400 mg orally twice daily. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

To evaluate the safety of valacyclovir 1 gram orally twice daily in HIV-1 seropositive persons. [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]


Estimated Enrollment:

38

Study Start Date:

December 2007

Estimated Study Completion Date:

December 2011

Estimated Primary Completion Date:

December 2011 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions

1: Experimental

valacyclovir 1 gram orally twice daily

Drug: valacyclovir

1 gram orally twice daily

2: Active Comparator

acyclovir 400 mg orally twice daily

Drug: acyclovir

400 mg orally twice daily


Detailed Description:

We propose to conduct a randomized, open-label, cross-over study of 38 individuals who are HIV-1 seropositive and HSV-2 seropositive. Both men and women will be recruited for the study. Participants must not be on antiretroviral therapy and must not be planning to initiate antiretroviral therapy during the anticipated study period. Participants will be randomized 1:1 to receive acyclovir 400 mg twice daily or valacyclovir 1000 mg twice daily. After 12 weeks on the initial treatment, each participant will be crossed over to the alternative treatment arm for 12 weeks. The treatment periods will be separated by a 2-week washout period. During the first four weeks of each treatment period (i.e., Weeks 1-4 and Weeks 15-18), participants will provide self-collected genital swabs daily for HSV detection. Each week during the entire study period, participants will provide plasma and genital samples for HIV-1 detection.

Open-label acyclovir and valacyclovir will be used for this trial, as the primary outcome measures (genital HSV and plasma and genital HIV-1) are unlikely to be influenced by knowledge of treatment assignment. However, laboratory staff performing plasma and genital HIV-1 measurements will not be aware of treatment assignment.

Eligibility


Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age 18 years or older

Documented HIV-1 seropositive

Not on HIV-1 antiretroviral therapy nor planning to initiate antiretroviral therapy during the study period

Detectable HIV-1 plasma viral load

HSV-2 seropositive as determined by western blot

Not intending to move out of the area for the duration of study participation

Willing and able to provide independent written informed consent

Willing and able to undergo clinical evaluations

Willing and able to take study drug as directed

Willing and able to adhere to follow-up schedule

Exclusion Criteria:

Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir

Planned open label use of acyclovir, valacyclovir, or famciclovir

History of evidence of CMV disease

Known medical history of seizures

Known renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl

AST or ALT greater than 3 times upper limit of normal

Hematocrit less than 30 %

Neutropenia, defined as absolute neutrophil count less than 1000

Thrombocytopenia, defined as platelet count less than 75,000

History of thrombotic microangiopathy

For women, pregnancy as confirmed by a urine pregnancy test

Any other condition which, in the opinion of the principal investigator, may compromise the ability to follow study procedures and complete the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527618


Contacts

Contact: Jared Baeten, MD, PhD

206-720-4340

jbaeten@u.washington.edu


Locations

United States, Washington

University of Washington Virology Research Clinic

Recruiting

Seattle, Washington, United States, 98122

Contact     206-720-4340     vrc@u.washington.edu

Sponsors and Collaborators

University of Washington

GlaxoSmithKline

Investigators

Principal Investigator:

Jared Baeten, MD, PhD

University of Washington

Study Director:

Anna Wald, MD, MPH

University of Washington

More Information


No publications provided


Responsible Party:

University of Washington ( Jared Baeten )

ClinicalTrials.gov Identifier:

NCT00527618 History of Changes

Other Study ID Numbers:

31203-D, GSK VAL111009 – VAL140

Study First Received:

September 7, 2007

Last Updated:

March 16, 2010

Health Authority:

United States: Institutional Review Board


Keywords provided by University of Washington:

Herpes Simplex Virus 2

Human Immunodeficiency Virus

Treatment Naive


Additional relevant MeSH terms:

Anti-Infective Agents

Sexually Transmitted Diseases, Viral

Slow Virus Diseases

Genital Diseases, Female

Valacyclovir

Therapeutic Uses

Retroviridae Infections

Herpes Simplex

RNA Virus Infections

Immune System Diseases

Skin Diseases

Herpes Genitalis

Acquired Immunodeficiency Syndrome

Genital Diseases, Male

Antiviral Agents

Pharmacologic Actions

Immunologic Deficiency Syndromes

Herpesviridae Infections

Virus Diseases

Skin Diseases, Viral

Skin Diseases, Infectious

Acyclovir

HIV Infections

Sexually Transmitted Diseases

Lentivirus Infections

DNA Virus Infections


ClinicalTrials.gov processed this record on June 15, 2010