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

Not Applicable

Completed

Conditions: HIV
HIV Infections

Interventions: Drug: Valacyclovir
Drug: Placebo

Registration Number: NCT00803543

Lead Sponsor: University of Alabama at Birmingham

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 103

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valacyclovir	Valacyclovir	This is the arm taking Valacyclovir
Placebo	Placebo	This is the arm taking the placebo

Primary Outcome Measures

Name	Time	Method
Number of Participants With an HIV Viral Load of <500 Copies/ml	24 weeks	Number of participants with an HIV Viral Load of \<500 copies/ml at 24 weeks
Rate of Asymptomatic HSV-2 Genital Shedding	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.
CD4 Count	24 weeks	CD4 count as measured after 24 weeks of placebo versus valacyclovir. Reports as cells/ml
Herpes Simplex Virus Type 2 Recurrence	24 Weeks	Number of recurrences of genital herpes