Search / Trial NCT00000927

A Study of BufferGel in Women

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Administration, Topical Mucous Membrane Anti Infective Agents Cervix Uteri Vagina Vulva Buffers

Description

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 inactivate...

Gender

Female

Eligibility criteria

  • 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.

Attachments

readout_NCT00000927_2024-06-14.pdf

4.5 MB

NCT00000927_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Pawtucket, Rhode Island, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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