The Tolerance of HIV-Infected Patients With Herpes Group Virus Infections to Oral Doses of FIAU...
Herpes SimplexHIV Infections1 moreTo determine the tolerance of HIV-infected patients to TID oral doses of FIAU syrup at 4 different dose levels. To determine the peak and trough blood levels of FIAU and its metabolites during two weeks of oral dosing with FIAU. The pyrimidine nucleoside analog FIAC and its primary deaminated uracil metabolite FIAU are highly and specifically active compounds in vitro against several herpes group viruses, particularly herpes simplex virus (HSV) types 1 and 2, varicella zoster (VZV), and cytomegalovirus (CMV), as well as hepatitis B virus (HBV). Since FIAU is the primary metabolite of FIAC and the administration of FIAU simplifies the metabolism of FIAC, it is anticipated from clinical studies of FIAC that FIAU will be tolerated at least as well as FIAC. A single-dose, pharmacokinetic (blood level) study showed that FIAC, when taken orally, is readily absorbed into the bloodstream, and most of it is converted to FIAU. Daily oral doses are expected to provide concentrations of FIAU exceeding the in vitro minimum inhibitory concentration for nearly all the herpes group viruses.
Comparison of Foscarnet Versus Vidarabine in the Treatment of Herpes Infection in Patients With...
Herpes SimplexHIV InfectionsTo compare the safety and effectiveness of foscarnet and vidarabine treatments for AIDS patients who have herpes simplex virus infections that are resistant to standard treatment with acyclovir. Foscarnet is a drug that inhibits viruses and has been shown to be effective against infection with Cytomegalovirus and also against infection with the Herpes simplex virus in several patients with AIDS. Vidarabine has been shown to have activity against the Herpes simplex virus in patients who do not have AIDS, but it has not been studied in patients who do have AIDS. This study compares foscarnet and vidarabine treatments for AIDS patients who have herpes simplex infection that has not responded to therapy with acyclovir in the hope that one of these two drugs will help to stop further progression of the herpes simplex infection and may have fewer side effects.
Efficacy of Lazolex® Gel in the Treatment of Herpes Simplex
HSV InfectionStudy aimed to evaluate the efficacy and tolerance of Lazolex®, an emollient gel, to treat mucocutaneous lesions caused by herpes simplex virus.
Vaginal Antibody Safety Trial: Safety Study of Monoclonal Antibodies to Reduce the Vaginal Transmission...
HIVHerpes Simplex InfectionsThe purpose of this study is to assess the safety and pharmacokinetics of MB66, a monoclonal antibody film for vaginal application that is being developed to potentially reduce the transmission of herpes simplex virus (HSV) and human immunodeficiency virus (HIV).
Immune Evidence to the Consumption of Lactobacillus GG and FOS Consumption in Patients With Herpes...
Herpes LabialisHerpes labialis (HL) is the result of the presence of a virus called HSV-1 and is a common disease. Because of its visibility due to cold sores it has a serious impact on social life. Until now there is no effective treatment to prevent virus outbreaks. However, prebiotics and probiotics have both been shown to have a favorable and supportive effect on the immune system in different health conditions such as influenza, atopic dermatitis and diarrhea, so it is possible that they are able to have a favourable effect also on HL. A recently completed pilot clinical trial (Protocol Number 08-SBUS-2-GRA-01, EVIM-1) was completed using a fermented milk (minidrink) containing a combination of L. rhamnosus and FOS; it showed promising results in the reduction of HL recurrences in a population of 78 subjects with HSV-1. The study investigated the effect of pre- or probiotics or a combination of the two on the recurrence of HL lesions as well as on the immune system in general, showing that the consumption of a minidrink containing the probiotic L. rhamnosus or a minidrink containing a combination of L. rhamnosus and FOS reduced the occurrence and the incidence of recurrent HL lesions. Aim of this study: corroborate whether the consumption of a minidrink containing a combination of L. rhamnosus and FOS results in less recurrence and a better progression of HL lesion, in a larger population. In addition, the response of the consumption of the minidrink on the QoL and the response on immunity specific biomarkers were evaluated. Design: 152 patients were eligible to participate in the study and after a run-in period of two weeks consuming a placebo minidrink were randomized to one of the two experimental study groups: placebo minidrink (n=79) and a minidrink containing a combination of a pre- and probiotic (n=78). These minidrinks were consumed until the end of the study (day 140). At day 33 of the study the lip most prone to the development of a lesion was stimulated with UVB to provoke a lesion. During the entire study period subjects were checked for any clinical signs of a lesion, completed a self-assessment regarding the lesion and a QoL questionnaire at baseline (day 14), at day 49 and the end of the study (day 140). In addition, a blood sample was collected at baseline, at day 49 and at the end of the study to be analyzed for HSV-specific antibody concentrations , to check immune system specific functions.
Safety and Efficacy Study of Herpes Simplex Virus Type 2 (HSV-2) Therapeutic DNA Vaccine
Herpes GenitalisThe purpose of this trial is to evaluate the safety and efficacy of a therapeutic DNA vaccine in adults with symptomatic herpes simplex virus type 2 (i.e., genital herpes).
Trial on Efficacy and Safety of Pritelivir Ointment for Treatment of Labial Herpes
Herpes LabialisRandomized, double-blind, multi-center, three arm parallel group, comparative trial to assess pritelivir ointment safety and efficacy, ie, proportion of subjects with non-ulcerative lesions, in adult subjects with recurrent herpes labialis (RHL) in comparison with placebo or Zovirax® Cream. The start of treatment with trial medication will be initiated by the subject within one hour of noticing the first sign or symptom (eg, prodrome) of a recurrence of herpes labialis. Trial medication will be applied to the affected area 5 times daily for 4 days. After self-initiation of treatment with trial medication subjects will be assessed daily by the Investigator until complete healing for a maximum of 13 days. Subjects will document application of trial medication and the status of their lesion in a diary. There will also be blood sampling, ECG measurement and physical examination performed at the investigational site.
Phase III Study of ASP2151 in Herpes Zoster Patients
Herpes ZosterTo evaluate the efficacy and safety of ASP2151 (200 mg and 400 mg) in comparison with valaciclovir (VACV) 3000 mg in patients with herpes zoster.
Effect of Tenofovir on Genital Herpes Simplex Virus (HSV) Shedding
Herpes Simplex Type IIThe investigators propose a randomized, double blind, placebo-controlled, cross-over trial to evaluate the effect of oral and topical (vaginal gel) tenofovir on genital herpes simplex virus (HSV) shedding among herpes simplex virus type-2 (HSV-2) seropositive, human immunodeficiency virus (HIV) seronegative women. The investigators hypothesize that tenofovir will reduce genital HSV shedding compared to placebo.
RELIEF: Randomized Episodic Versus Long-Term Suppression Experience With Famciclovir
Recurrent Genital Herpes (RGH)This trial will assess whether RGH patients who have two recurrent episodes within a three month period would benefit from suppressive treatment and whether patients prefer episodic therapy or suppressive therapy for the treatment of their RGH.