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

NCT00723229 | Completed Phase 4 Results

• 2 other identifiers: 34187-BU19AI031448
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Genital Herpes

Outcome Measures

Primary Outcomes (1)

• 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 Seronegative and HIV Seropositive Individuals.

  9 weeks

Secondary Outcomes (3)

• Quantity of HSV Detected, Median

  9 weeks

• Number of Genital HSV Shedding Episodes

  9 weeks

• Duration of Genital HSV Shedding Episodes

  9 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: acyclovir

2

NO INTERVENTION

Interventions

acyclovir DRUG

Acyclovir 400 mg PO BID for 28 days

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Washington Virology Research Clinic

Seattle, Washington, 98122, United States

Location

Related Publications (1)

• Johnston C, Saracino M, Kuntz S, Magaret A, Selke S, Huang ML, Schiffer JT, Koelle DM, Corey L, Wald A. Standard-dose and high-dose daily antiviral therapy for short episodes of genital HSV-2 reactivation: three randomised, open-label, cross-over trials. Lancet. 2012 Feb 18;379(9816):641-7. doi: 10.1016/S0140-6736(11)61750-9. Epub 2012 Jan 4.

  PMID: 22225814 DERIVED

MeSH Terms

Conditions

Herpes Genitalis

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was performed at a single site and enrolled a mostly white population. Whether these results are generalizable to other populations is not known.

Results Point of Contact

• Title: Dr. Christine Johnston
• Organization: University of Washington

cjohnsto@u.washington.edu

206-520-4340

Study Officials

• Christine Johnston, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2008
• First Posted: July 28, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2011
• Last Updated: March 9, 2017
• Results First Posted: March 9, 2017

Record last verified: 2017-03

Locations

US (1)