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Genital Herpes clinical trials

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NCT ID: NCT01390805 Completed - Genital Herpes Clinical Trials

Special Drug Use Investigation for VALTREX (Valaciclovir) (Suppression Prophylaxis)

Start date: November 2006
Phase: N/A
Study type: Observational

The purpose of this study is to collect and assess information on proper use of valaciclovir regarding safety and efficacy of long-term use in suppressive therapy for subjects with recurrent genital herpes.

NCT ID: NCT01346475 Completed - Genital Herpes Clinical Trials

Randomized Trial to Evaluate Suppressive Effect of High-Dose Valacyclovir Versus Once-Daily Valacyclovir on Persons With HSV-2

Start date: November 2008
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT01281007 Completed - GENITAL HERPES Clinical Trials

Efficacy of Oral Famciclovir 125mg Comparing to Aciclovir 200 mg Treatment in Patients With Active Recurrent Genital Herpes

Start date: July 2012
Phase: Phase 3
Study type: Interventional

Recurrent genital herpes is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are effective oral prescription antiviral medicines available to reduce the discomfort of symptoms, such as famciclovir and aciclovir. This is a phase III, multicenter, randomized, parallel-group study to compare the efficacy and safety of treatment with famciclovir (125 mg) versus aciclovir (200 mg) in patients with active recurrent genital herpes.

NCT ID: NCT01132729 Completed - Herpes Zoster Clinical Trials

Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fasting Conditions

Start date: September 2006
Phase: N/A
Study type: Interventional

The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fasting conditions.

NCT ID: NCT01132716 Completed - Herpes Zoster Clinical Trials

Bioequivalency Study of Valacyclovir Hydrochloride 1000 mg Under Fed Conditions

Start date: September 2006
Phase: N/A
Study type: Interventional

The objective of this study was to prove the bioequivalence of Valacyclovir Hydrochlorothiazide Caplet under fed conditions.

NCT ID: NCT01112956 Completed - Genital Herpes Clinical Trials

Serologic Assays for the Diagnosis of Herpes Simplex Virus Type 2

Start date: July 2009
Phase: N/A
Study type: Observational

The purposes of this study are: - To determine the accuracy of commercially available serologic assays in diagnosing patients with herpes simplex virus type 2 (HSV-2); - To assess the sensitivity and specificity of the commerical assays using HSV-2 western blot as the "gold standard" in a diverse patient population; - To develop testing strategies and recommendations for screening asymptomatic populations for HSV-2.

NCT ID: NCT00808405 Completed - Genital Herpes Clinical Trials

GUD Clinical and Virologic Response to Acyclovir in HIV Negative African Women

PK/GUD
Start date: January 2009
Phase: N/A
Study type: Interventional

To examine the time to healing of genital lesion and duration of herpes simplex virus (HSV) shedding from genetic ulcer disease (GUD) among 90 HIV-negative African women who have a history of GUD and are HSV-2 seropositive and HIV-1 seronegative randomized in a 2:1 ratio to receive episodic acyclovir 400mg orally three times daily or matching placebo three times daily for 5 days and who are followed for a total of 13 days.

NCT ID: NCT00723229 Completed - Genital Herpes Clinical Trials

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

Start date: August 2008
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT00527618 Completed - HIV Infection Clinical Trials

Trial to Study the Effect of Dose of Herpes Simplex Virus-2 (HSV-2) Suppressive Therapy on HSV and HIV

Start date: December 2007
Phase: Phase 4
Study type: Interventional

To compare the effect of high-dose valacyclovir (1 gram orally twice daily) versus standard-dose acyclovir (400 mg orally twice daily) on the frequency of genital HSV reactivation and on plasma HIV-1 levels among HSV-2/HIV-1 co-infected individuals. The investigators hypothesize that high-dose valacyclovir will result in greater reduction in plasma HIV-1 and genital HSV reactivation.

NCT ID: NCT00495716 Terminated - Genital Herpes Clinical Trials

Effect of HSV-2 Suppressive Therapy on Sexual Behavior

Start date: January 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine what effect suppressive therapy has on sexual behavior and quality of life among persons with genital herpes (HSV) who have multiple sex partners. Study terminated; investigator relocated and study funding ended. Results were never analyzed because data were not collected.