Phase I Vaginal Microbicide Study of BufferGel
BufferGel
Infections transmises par le sang+11
+ Maladies génito-urinaires
+ Maladies Génitales
Étude de prévention
Résumé
Heterosexual transmission of HIV presently accounts for the vast majority of new HIV infections worldwide. Currently the condom is the only method available that has been shown to be effective against HIV and other sexually transmitted diseases (STDs). However, women who are at the greatest risk for acquiring HIV are often unable to negotiate condom use. Therefore, it is important that effective female-controlled barrier methods, such as topical microbicides, be made available to women. BufferGel has sufficient buffer capacity to acidify twice its own volume in human semen, which inactivates STD pathogens, including HIV. Unlike most other topical microbicides, BufferGel is non-detergent so it should not cause genital irritation and lesions. The safety and acceptability of BufferGel still need to be studied more carefully. Participants are divided into two cohorts. Cohort IA consists of sexually abstinent women and cohort IB consists of sexually active women. Within each U.S. cohort, participants are assigned to apply BufferGel either once or twice daily. Within each international cohort, all participants apply BufferGel twice daily. Participants apply BufferGel for 14 days. Pelvic examinations are performed at Days 7 and 14.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.40 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 45 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria All participants must have: HIV-negativity by licensed EIA. Willingness and ability to complete a study diary. A regular menstrual cycle with a minimum of 18 days between menses. Ability to insert BufferGel daily as required by the protocol. Cohort IA participants must: Agree to abstain from sexual intercourse for the duration of the study. Cohort IB participants must: Agree to have vaginal intercourse at least 2 times per week and use non-lubricated condoms for each act of intercourse. Have currently (for 3 months or longer) a single sexual partner who is at low-risk for HIV infection. Exclusion Criteria Co-existing Condition: Participants with the following conditions or symptoms are excluded: A Grade 3 or higher liver, renal, or hematology abnormality. Menopausal. Breakthrough menstrual bleeding. Any STD or symptoms, as seen on pelvic exam, consistent with an STD or other genital tract infection or trauma including vaginitis, cervicitis, edema, erythema, ecchymosis, petechial hemorrhage, vulvar or cervicovaginal lesions or abrasions, subepithelial hemorrhage, or signs of genital tract infection (other than asymptomatic bacterial vaginosis) from laboratory evaluations. Concurrent Medication: Excluded: Any vaginal product other than BufferGel, including lubricants and feminine hygiene products. Vaginal drying agents. Douche. Participation in any other microbicide or contraceptive study. Treatment for any STD. Participants with the following prior conditions are excluded: IUD, abnormal PAP smear, pregnancy, abortion, or gynecologic surgery in the last 3 months. Any of the following side effects related to Depo-provera use in the past 2 months: headaches, dizziness, abdominal pain, fatigue, or nervousness. Prior Medication: Excluded: A course of antibiotic therapy (other than treatment for malaria) in the last 14 days. Any spermicide within the past month. Initiation of Depo-provera for contraceptive purposes in the last 6 months. Risk Behavior: Excluded: Use of intravenous drugs currently or within the past year.
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site