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Genital Herpes clinical trials

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NCT ID: NCT00495573 Completed - Genital Herpes Clinical Trials

HSV-2 Shedding Resolution After Acyclovir Treatment

Start date: June 2007
Phase: N/A
Study type: Observational

The purpose of the study is to evaluate the pattern of viral shedding after beginning treatment with acyclovir for a clinical recurrence of genital herpes and to compare it with the pattern of viral shedding during an untreated clinical recurrence of genital herpes.

NCT ID: NCT00477334 Completed - Genital Herpes Clinical Trials

Patient-initiated Episodic Treatment of Recurrent Genital Herpes in Black Patients

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

This study will evaluate the safety and efficacy of single-day famciclovir episodic treatment in Black patients with recurrent genital herpes

NCT ID: NCT00362297 Completed - Genital Herpes Clinical Trials

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

Start date: September 2006
Phase: Phase 4
Study type: Interventional

The purpose of the research study is to evaluate the effectiveness of high-dose acyclovir compared to valacyclovir for reduction of asymptomatic 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 15-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 valacyclovir or acyclovir; you will receive both medications at some point during this study). There will be a total of 9 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: NCT00306787 Completed - Genital Herpes Clinical Trials

Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir in Adults With Recurrent Genital Herpes

Start date: March 2006
Phase: Phase 3
Study type: Interventional

This study will assess the safety and efficacy of one-day famciclovir (1000 mg twice a day (b.i.d)) in reducing the duration of genital herpes lesions and the associated symptoms compared to three-day treatment with valacyclovir (500 mg capsule b.i.d).

NCT ID: NCT00262106 Completed - HIV Infections Clinical Trials

Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection

Start date: October 2005
Phase: Phase 3
Study type: Interventional

The objective of the study is to determine the efficacy and safety of 0.5% and 2% PRO 2000/5 gels compared to placebo in preventing vaginally acquired HIV infection.

NCT ID: NCT00231049 Completed - Genital Herpes Clinical Trials

Trial Evaluating Safety, Tolerability and Immune Response of AG-707

Start date: March 2006
Phase: Phase 1
Study type: Interventional

This is a randomized, multi-center, sequential, dose-escalating study of three dose cohorts of AG-707. Individuals who meet all of the inclusion and exclusion criteria for eligibility will be randomized to receive either AG-707 (at the 80 µg dose), AG-707 with QS-21 (at the 80 µg dose), placebo, or QS-21. Each patient will be monitored for safety as specified in the protocol.

NCT ID: NCT00129818 Completed - Genital Herpes Clinical Trials

A Study to Evaluate the Effect of Famciclovir in Reducing Herpes Virus Shedding

Start date: July 2004
Phase: Phase 4
Study type: Interventional

The study is designed to assess the efficacy and safety of famciclovir 250 mg twice a day (bid) suppressive treatment in men and women with herpes virus type 2 (HSV-2) infection, with and without a reported history of genital herpes and with or without herpes virus type 1 (HSV-1) seropositivity.

NCT ID: NCT00124878 Active, not recruiting - HIV Infections Clinical Trials

Trial of Male Circumcision: HIV, Sexually Transmitted Disease (STD) and Behavioral Effects in Men, Women and the Community

Start date: August 2003
Phase: Phase 3
Study type: Interventional

This randomized controlled trial conducted in Rakai District, Uganda, has enrolled 997 HIV positive men and 500 men who declined to learn HIV results (regardless of HIV status). The hypotheses are that male circumcision will be acceptable to and safe in both groups and will reduce the rates of STD acquisition in both groups and of HIV acquisition in HIV-negative men. Enrollment was ended on Dec 12, 2006, following an interim Data Monitoring and Safety Board (DSMB) review of a closed report. At that time the DSMB determined that futility with respect to the female HIV outcome. There was an non-significantly higher rate of HIV acquisition in women partners of HIV+ men in couples who had resumed sex prior to certified post-surgical wound healing. The data indicated significant reductions (~50%) in GUD symptoms among circumcised HIV+ men. The DSMB recommended: 1) that men and women should continue to be followed in complete two year follow up on all, 2) that circumcision for remaining HIV+ intervention arm men and for control arm men who had completed their 2 year follow should continue, contingent on a) revision of the study protocol to add additional post-surgical visits to assess wound healing, b) protocol revision to further strengthen education for both male and female partners on the need to postpone sex until certified wound healing, and c) approval of the revised protocol by the IRBs in both the US and Uganda. 3) An additional follow up visit for women be instituted at 18 months after enrollment. Protocol revision and IRB approvals have been finalized in June, 2007. The study has also enrolled and is following 3,700 women sexual partners of men enrolled in this study and in a complementary National Institutes of Health (NIH) funded study (U1 AI51171 which is separately registered). The hypotheses are that male circumcision will be acceptable to and safe in women partners, and will reduce the women's acquisition of HIV and STDs such as herpes simplex virus-2 (HSV-2) and human papillomavirus (HPV).