Effect of Valacyclovir in the Reduction of HSV-2 Recurrence and Shedding - Full Text View

Purpose

The purpose of the study is to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.

Condition	Intervention
HIV HIV Infections	Drug: Valacyclovir Drug: Placebo


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment
Official Title:	Seroprevalence of HSV-2 in HIV Infected Subjects and the Effect of Daiy Valacyclovir in the Reduction of HSV-2 Recurrences and Viral Shedding

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Valacyclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by Nicholas Van Wagoner, MD, University of Alabama at Birmingham:

Primary Outcome Measures:

Herpes Simplex Virus Type 2 Recurrence [ Time Frame: 24 Weeks ]
Number of recurrences of genital herpes
CD4 Count [ Time Frame: 24 weeks ]
CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml
Number of Participants With an HIV Viral Load of <500 Copies/ml [ Time Frame: 24 weeks ]
Number of participants with an HIV Viral Load of <500 copies/ml at 24 weeks
Rate of Asymptomatic HSV-2 Genital Shedding [ Time Frame: 24 weeks ]
Proportion of days on which HSV shedding was observed. This part of the study was performed in a subset of participants (N = 34). Participant collected daily genital specimens for 8 weeks starting at week 16 and continuing through week 24 of the study.


Enrollment:	103
Study Start Date:	January 2009
Study Completion Date:	April 2014
Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Valacyclovir This is the arm taking Valacyclovir	Drug: Valacyclovir 500 mg tablets. Dosage two tablets (1000 mg)once daily for 24 weeks Other Name: There are no other names
Placebo Comparator: Placebo This is the arm taking the placebo	Drug: Placebo Dosage: Two tablets once a day for 24 weeks Other Name: There are no other names

Detailed Description:

Most people with herpes infections do not know they have the infection. HSV infections most often occur in areas in and around the mouth and genital tract. HSV Type 1 (HSV-1) usually causes "cold sores" or fever blisters and HSV Type 2 (HSV-2) usually causes lesions in the genital or rectal areas. However, HSV-1 can sometimes cause genital herpes and HSV-2 can cause oral lesions (acquired from oral-genital sex). Herpes Simplex is transmitted by contact with someone who is shedding virus in either the mouth or genital tract, usually by kissing or sexual intercourse. While contact with an active sore can cause transmission, so can contact with saliva or genital secretions that are infected, even when the person does not have an obvious sore. This is called asymptomatic shedding of HSV. Once acquired, the virus has the ability to remain inactive in the nervous system in the area of the mouth or genital region.

Persons with both HIV and HSV-2 often have shedding of both viruses. We know that persons with HSV-2 tend to have increased amounts of HIV in their blood as well. Recently, research studies have found that taking medicine daily to prevent asymptomatic HSV-2 shedding can reduce the amount of HIV found in the blood and in genital secretions. This study seeks to determine how common herpes is among persons with HIV who do not know they have it and if valacyclovir (FDA approved drug) reduces outbreaks of herpes, the amount of HIV in the blood, and the amount of HSV in bodily secretions.

Eligibility


Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

19 years or older
HSV-2 (Herpes simplex virus type 2) seropositive as determined by HerpeSelect-2 ELISA
Documented HIV-1 seropositive
Currently receiving HAART for 3 months or longer
CD4 (cluster of differentiation 4) count 350 or greater
Women of child bearing potential must agree to use acceptable contraceptive measures during the entire conduct of the study. Acceptable contraceptive methods include one or more of the following: oral hormonal contraceptives, injectable hormonal contraceptives, transdermal hormonal contraceptives, IUD (intrauterine device), diaphragm or cervical cap.
Willing and able to provide written informed consent, undergo clinical evaluations, and take study drug as directed

Exclusion Criteria:

History of symptomatic genital herpes, lesions or symptoms consistent with genital herpes, or recurrent undiagnosed symptoms consistent with genital herpes.
Known history of adverse reaction to acyclovir, valacyclovir, or famciclovir.
Planned open label use of acyclovir, valacyclovir, ganciclovir, valganciclovir, famciclovir, cidofovir, or foscarnet for oral herpes or other herpes viral infections.
Medical history of seizures
Renal insufficiency, defined as serum creatinine greater than 1.5 mg/dl
AST (aspartate aminotransferase) or ALT (alanine aminotransferase) over 5 times uper limit of normal
History of thrombotic microangiopathy
For women, pregnancy as confirmed by a urine or serum pregnancy test.
Any other condition which, in the opinion of the principal investigator, may compromise the subject's ability to follow study procedures and complete the study.
Participants with active bacterial STDs (sexually transmitted diseases) may be treated and be eligible for enrollment 14 days after STD therapy is discontinued and symptoms have resolved.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00803543

Locations


United States, Alabama
Community Care Building
Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

GlaxoSmithKline

Investigators


Principal Investigator:	Nicholas Van Wagoner, MD	University of Alabama at Birmingham

More Information


Responsible Party:	Nicholas Van Wagoner, MD, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00803543 History of Changes
Other Study ID Numbers:	F080718009
Study First Received:	December 3, 2008
Results First Received:	July 11, 2015
Last Updated:	June 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Nicholas Van Wagoner, MD, University of Alabama at Birmingham:


HSV-2 Herpes Simplex HSV Type 2	HIV HIV/HSV treatment experienced

Additional relevant MeSH terms:


HIV Infections Recurrence Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Immunologic Deficiency Syndromes Immune System Diseases Disease Attributes Pathologic Processes Valacyclovir Acyclovir Antiviral Agents Anti-Infective Agents

ClinicalTrials.gov processed this record on August 18, 2017