Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Cross-Over Study to Evaluate the Suppressive Effect of High-Dose Valacyclovir Versus Once Daily Valacyclovir on Herpes Simplex Virus Type 2 Genital Shedding in Herpes Simplex Virus-2 Seropositive Adults
Brief Summary: On 13 August 2008, this trial was submitted to ClinicalTrials.gov as modification to NCT00362297. On 28 April 2011, the two records were split for administrative purposes and each trial was given its own unique study record. Please refer to the "History of Changes" on posting NCT00362297 for a detailed summary of the modifications.

The purpose of the research study is to evaluate the effectiveness of high-dose valacyclovir compared to once daily valacyclovir for reduction of asymptomatic HSV-2 genital shedding in persons with genital herpes.

The study will enroll men and women who are 18 years or older, test positive to HSV-2 (by blood test) and have had a first outbreak of HSV-2 within the past 6 months or have had at least 4 genital herpes outbreaks in the past year. Participants must be HIV negative and willing to stop taking suppressive therapy for HSV for the one week wash out period. (Females only: You must not be pregnant or breast-feeding). Both men and women will be asked to use an effective form of birth control.

Involvement in the study will last 11-weeks and you will be asked to visit the clinic every 2-weeks. At each visit, you will be given medication to take daily (either once daily valacyclovir or high dose valacyclovir; you will receive both medications at some point during this study). We will ask you to give a blood sample for liver, kidney and blood count testing at each visit. There will be a total of 8 study visits and each visit will last approximately 30 minutes. We will ask that you complete a daily symptom diary and collected daily home swabs 4-times a day, everyday during the study. Each daily home swab will take less than 3 minutes to perform.


Options:
A: Arm Label: Famciclovir; Type: EXPERIMENTAL; Interventions: Drug: Famciclovir, Drug: Placebo matching valacyclovir | Arm Label: Valacyclovir; Type: ACTIVE_COMPARATOR; Interventions: Drug: Valacyclovir, Drug: Placebo matching famciclovir | Intervention Type: DRUG; Name: Famciclovir; Assigned to Arm(s): Famciclovir | Intervention Type: DRUG; Name: Valacyclovir; Assigned to Arm(s): Valacyclovir | Intervention Type: DRUG; Name: Placebo matching famciclovir; Assigned to Arm(s): Valacyclovir | Intervention Type: DRUG; Name: Placebo matching valacyclovir; Assigned to Arm(s): Famciclovir
B: Arm Label: valacyclovir; Type: ACTIVE_COMPARATOR; Interventions: Drug: Valacyclovir | Arm Label: high dose valacyclovir; Type: EXPERIMENTAL; Interventions: Drug: valacyclovir | Intervention Type: DRUG; Name: valacyclovir; Assigned to Arm(s): high dose valacyclovir | Intervention Type: DRUG; Name: Valacyclovir; Assigned to Arm(s): valacyclovir
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Acyclovir | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Acyclovir placebo | Intervention Type: DRUG; Name: Acyclovir; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Acyclovir placebo; Assigned to Arm(s): 2
D: Intervention Type: DRUG; Name: Famciclovir; Assigned to Arm(s): N/A

Answer: B