Clinical Trials For Genital Herpes A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation

A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation

This study is currently recruiting participants.

Verified by University of Washington, March 2010

First Received: July 23, 2008   Last Updated: March 17, 2010   History of Changes

Sponsor:

University of Washington

Collaborator:

National Institutes of Health (NIH)

Information provided by:

University of Washington

ClinicalTrials.gov Identifier:

NCT00723229

Purpose

We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial. We hypothesize that short bursts of HSV-2 reactivation will not be suppressed by acyclovir.


Condition

Intervention

Phase

Genital Herpes

Drug: acyclovir

Phase IV


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Uncontrolled

Endpoint Classification: Efficacy Study

Intervention Model: Crossover Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title:

A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of Acyclovir on Rapidly Cleared Herpes Simplex Virus Type 2 Genital Reactivation Episodes in Herpes Simplex Virus-2 Seropositive Adults


Resource links provided by NLM:


MedlinePlus related topics: Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources


Further study details as provided by University of Washington:


Primary Outcome Measures:

Frequency of HSV-2 total shedding from the genital tract as measured by PCR, calculated using a per-day shedding rate in participants treated with suppressive acyclovir as compared to no medication in HIV sero-negative AND HIV seropositive individuals. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

Frequency of subclinical shedding from the genital tract as measured by PCR, calculated using a per-day shedding rate in participants treated with with suppressive acyclovir as compared to no medication. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Frequency of lesional shedding from the genital tract as measured by PCR, calculated using a per day shedding rate in participants treated with with suppressive acyclovir as compared to no medication. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Number of herpes recurrences, defined clinically as >=1 successive day on which genital lesions are present, in participants treated with with suppressive acyclovir as compared to no medication. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:

50

Study Start Date:

August 2008

Estimated Study Completion Date:

September 2011

Estimated Primary Completion Date:

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

Arms

Assigned Interventions

1: Active Comparator

Drug: acyclovir

Acyclovir 400 mg PO BID for 28 days

2: No Intervention



Detailed Description:

We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial.

We propose to perform this study in two study populations. Cohort 1 will be comprised of 25 HSV-2 seropositive, HIV seronegative adults, and Cohort 2 will be comprised of 25 HSV-2 seropositive, HIV seropositive adults with a CD4 count>250 cells/mm3. As suppression of HSV-2 using acyclovir is currently being studied in large, multi-center, international clinical trials as an HIV prevention strategy, these results will have broad implications for public health around the world.

Eligibility


Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

COHORT 1: HIV seronegative

Older than 18 years;

HSV-2 seropositive by Western Blot;

not receiving any drugs with known anti-HSV-2 activity for study duration;

women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;

women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;

in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient’s medical history;

planning to remain resident in the area of the study center for the duration of the study participation;

HIV seronegative

COHORT 2: HIV seropositive

Older than18 years;

HSV-2 seropositive by Western Blot;

not receiving any drugs with known anti-HSV-2 activity for study duration;

women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;

women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;

in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient’s medical history;

planning to remain resident in the area of the study center for the duration of the study participation;

HIV seropositive

CD4 count over 250 cell/mm3

Not taking antiretroviral therapy

Exclusion Criteria:

For both cohorts:

hypersensitivity to acyclovir or valacyclovir;

pregnant women;

Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory drugs.

For cohort 2:

CD4 count<250 cell/mm3

Taking antiretroviral therapy at the time of study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723229


Contacts

Contact: Christine Johnston, MD, MPH

206-720-4340

cjohnsto@u.washington.edu


Locations

United States, Washington

University of Washington Virology Research Clinic

Recruiting

Seattle, Washington, United States, 98122

Contact: Christine Johnston, MD, MPH     206-720-4340     cjohnsto@u.washington.edu

Principal Investigator: Christine Johnston, MD, MPH

Sponsors and Collaborators

University of Washington

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Christine Johnston, MD, MPH

University of Washington

More Information


No publications provided


Responsible Party:

University of Washington ( Christine Johnston, MD, MPH )

ClinicalTrials.gov Identifier:

NCT00723229 History of Changes

Other Study ID Numbers:

34187-B

Study First Received:

July 23, 2008

Last Updated:

March 17, 2010

Health Authority:

United States: Institutional Review Board


Additional relevant MeSH terms:

Herpes Simplex

Anti-Infective Agents

Sexually Transmitted Diseases, Viral

Skin Diseases

Herpes Genitalis

Genital Diseases, Male

Antiviral Agents

Pharmacologic Actions

Herpesviridae Infections

Virus Diseases

Genital Diseases, Female

Skin Diseases, Viral

Skin Diseases, Infectious

Acyclovir

Therapeutic Uses

Sexually Transmitted Diseases

DNA Virus Infections


ClinicalTrials.gov processed this record on June 15, 2010

A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation

This study is currently recruiting participants.

Verified by University of Washington, March 2010

First Received: July 23, 2008   Last Updated: March 17, 2010   History of Changes

Sponsor:

University of Washington

Collaborator:

National Institutes of Health (NIH)

Information provided by:

University of Washington

ClinicalTrials.gov Identifier:

NCT00723229

Purpose

We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial. We hypothesize that short bursts of HSV-2 reactivation will not be suppressed by acyclovir.


Condition

Intervention

Phase

Genital Herpes

Drug: acyclovir

Phase IV


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Uncontrolled

Endpoint Classification: Efficacy Study

Intervention Model: Crossover Assignment

Masking: Open Label

Primary Purpose: Treatment

Official Title:

A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of Acyclovir on Rapidly Cleared Herpes Simplex Virus Type 2 Genital Reactivation Episodes in Herpes Simplex Virus-2 Seropositive Adults


Resource links provided by NLM:


MedlinePlus related topics: Herpes Simplex

Drug Information available for: Acyclovir Acyclovir sodium

U.S. FDA Resources


Further study details as provided by University of Washington:


Primary Outcome Measures:

Frequency of HSV-2 total shedding from the genital tract as measured by PCR, calculated using a per-day shedding rate in participants treated with suppressive acyclovir as compared to no medication in HIV sero-negative AND HIV seropositive individuals. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]


Secondary Outcome Measures:

Frequency of subclinical shedding from the genital tract as measured by PCR, calculated using a per-day shedding rate in participants treated with with suppressive acyclovir as compared to no medication. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Frequency of lesional shedding from the genital tract as measured by PCR, calculated using a per day shedding rate in participants treated with with suppressive acyclovir as compared to no medication. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Number of herpes recurrences, defined clinically as >=1 successive day on which genital lesions are present, in participants treated with with suppressive acyclovir as compared to no medication. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]


Estimated Enrollment:

50

Study Start Date:

August 2008

Estimated Study Completion Date:

September 2011

Estimated Primary Completion Date:

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

Arms

Assigned Interventions

1: Active Comparator

Drug: acyclovir

Acyclovir 400 mg PO BID for 28 days

2: No Intervention



Detailed Description:

We propose to study the episode rate, duration, and quantity of HSV-2 genital shedding in patients taking standard, FDA approved, CDC recommended doses of acyclovir (400 mg PO BID) for HSV-2 suppression compared to taking no medication to better define the effect of acyclovir on short bursts of rapidly cleared HSV-2 shedding. This study will be a randomized, open label, cross-over trial.

We propose to perform this study in two study populations. Cohort 1 will be comprised of 25 HSV-2 seropositive, HIV seronegative adults, and Cohort 2 will be comprised of 25 HSV-2 seropositive, HIV seropositive adults with a CD4 count>250 cells/mm3. As suppression of HSV-2 using acyclovir is currently being studied in large, multi-center, international clinical trials as an HIV prevention strategy, these results will have broad implications for public health around the world.

Eligibility


Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

COHORT 1: HIV seronegative

Older than 18 years;

HSV-2 seropositive by Western Blot;

not receiving any drugs with known anti-HSV-2 activity for study duration;

women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;

women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;

in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient’s medical history;

planning to remain resident in the area of the study center for the duration of the study participation;

HIV seronegative

COHORT 2: HIV seropositive

Older than18 years;

HSV-2 seropositive by Western Blot;

not receiving any drugs with known anti-HSV-2 activity for study duration;

women of child bearing potential who are sexually active with men must be using a medically accepted method of contraception as judged by the investigator;

women of child-bearing potential must have a negative pregnancy test (urine) at screening visit;

in general good health, without other serious medical conditions and specifically with normal renal and hepatic function, as determined by the patient’s medical history;

planning to remain resident in the area of the study center for the duration of the study participation;

HIV seropositive

CD4 count over 250 cell/mm3

Not taking antiretroviral therapy

Exclusion Criteria:

For both cohorts:

hypersensitivity to acyclovir or valacyclovir;

pregnant women;

Taking immunosuppressive therapies, such as chronic oral steroids or immune modulatory drugs.

For cohort 2:

CD4 count<250 cell/mm3

Taking antiretroviral therapy at the time of study entry

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723229


Contacts

Contact: Christine Johnston, MD, MPH

206-720-4340

cjohnsto@u.washington.edu


Locations

United States, Washington

University of Washington Virology Research Clinic

Recruiting

Seattle, Washington, United States, 98122

Contact: Christine Johnston, MD, MPH     206-720-4340     cjohnsto@u.washington.edu

Principal Investigator: Christine Johnston, MD, MPH

Sponsors and Collaborators

University of Washington

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Christine Johnston, MD, MPH

University of Washington

More Information


No publications provided


Responsible Party:

University of Washington ( Christine Johnston, MD, MPH )

ClinicalTrials.gov Identifier:

NCT00723229 History of Changes

Other Study ID Numbers:

34187-B

Study First Received:

July 23, 2008

Last Updated:

March 17, 2010

Health Authority:

United States: Institutional Review Board


Additional relevant MeSH terms:

Herpes Simplex

Anti-Infective Agents

Sexually Transmitted Diseases, Viral

Skin Diseases

Herpes Genitalis

Genital Diseases, Male

Antiviral Agents

Pharmacologic Actions

Herpesviridae Infections

Virus Diseases

Genital Diseases, Female

Skin Diseases, Viral

Skin Diseases, Infectious

Acyclovir

Therapeutic Uses

Sexually Transmitted Diseases

DNA Virus Infections


ClinicalTrials.gov processed this record on June 15, 2010