A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected...
Herpes GenitalisThis clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count <100 cells/mm3.
Study of 2LHERP® in Genital Herpes Infections
Herpes SimplexGenitalHerpes simplex virus (HSV) infection is very common, as most people will experience herpetic infection during their lifetime. The most common manifestation of HSV infection is sores which may appear at any age. No specific antiviral therapy is available to totally cure herpetic infections and today, there is no treatment that allows the definitive eradication of the virus. The 2LHERP® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of herpetic infections. Since 2LHERP® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the disappearance of herpetic recurrences. The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LHERP® on the treatment of herpetic infections in adults.
A Study to Investigate the Efficacy, Safety and Tolerability of PEG in Patients With Genital Herpes...
Genital HerpesThe aim of this study is therefore to investigate the efficacy of the PEG-formulation to reduce the frequency and duration of genital herpes recurrences, to assess its safety and tolerability and to investigate its effect on shedding.
Evaluating New Formulation of Therapeutic HSV-2 Vaccine
Genital Herpes Simplex Type 2This study evaluates the reduction in viral shedding after vaccination with a new formulation of GEN-003 in subjects with genital HSV-2 infection. Two-thirds of the participants will receive GEN-003, one-third will receive placebo.
Dose Ranging Safety and Efficacy of Therapeutic HSV-2 Vaccine
Genital Herpes Simplex Type 2This is a randomized, double-blind, factorial study to compare the reduction in viral shedding among 6 different combinations of GEN-003, a therapeutic HSV-2 vaccine and Matrix-M2 adjuvant. Secondary objectives of the study include: Evaluation of the safety and tolerability of GEN-003 in combination with Matrix-M2 compared to placebo. Comparison of the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among the 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: Time to first clinical and/or virologic recurrence, Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine, Lesion rate (percent of days with genital lesions present) during the post-vaccination swabbing periods. Evaluation of cellular and humoral responses to GEN-003 antigens. Additional objectives include: Assessment of the correlation between immune responses and change in viral shedding or impact on clinical disease as defined above. Determination of the recurrence rate in a subset of subjects not receiving suppressive antivirals throughout the study. Eligible subjects will enter a baseline period to collect anogenital swabs for 28 consecutive days prior to randomization. Each subject will receive up to 3 doses at 21 day intervals. Subjects will be followed for safety and immunologic response for 12 months following their last dose.
Biological Efficacy Study of HerpV Vaccine With QS-21 to Treat Participants With Recurrent Genital...
Herpes Simplex Type 2The purpose of this study is to evaluate the effect of recombinant human heat shock protein 70-polyvalent peptide complex (HerpV) vaccine administration on recurring episodes of genital herpes by evaluating viral shedding before and after treatment.
A Randomized Trial to Evaluated the Suppressive Effect of Acyclovir on Rapidly Cleared HSV-2 Reactivation...
Genital HerpesWe 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.
Efficacy and Safety of Famciclovir 1-day Treatment Compared to 3-day Treatment With Valacyclovir...
Genital HerpesThis 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).
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
Genital Herpes Simplex Type 2This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2. Objectives: To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6 different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by: Time to first clinical and/or virologic recurrence after Dose 3 (Day 43) Proportion of subjects who are recurrence free at 6 and 12 months after the last dose of vaccine Lesion rate (percent of days with genital lesions present) during the post-vaccination follow-up period Antiviral use. To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.
Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
Genital Herpes Simplex Type 2The purpose of this study is to test the safety and effectiveness of two experimental therapeutic vaccines against herpes simplex virus, type 2 (HSV-2).