NCT00000927

Brief Summary

The purpose of this study is to see if it is safe to use BufferGel in the vaginas of women who do not have HIV and who have a low risk of getting HIV. Many new cases of HIV are the result of heterosexual activity. Condom use is currently the only effective way of preventing the spread of HIV and other sexually transmitted diseases (STDs). However, women, who have a greater risk of getting HIV, are often unable to convince their partner to use a condom. Therefore, it is important to develop methods that prevent the spread of HIV and that are controlled by the woman, such as medicines used in the vagina. BufferGel is known to kill the organisms that cause STDs, including HIV. BufferGel may do this without causing genital irritation and sores as other medicines do. More studies are needed to see if this is true.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

January 9, 2007

Status Verified

March 1, 1999

First QC Date

November 2, 1999

Last Update Submit

January 8, 2007

Conditions

HIV Infections

Keywords

Administration, TopicalMucous MembraneAnti-Infective AgentsCervix UteriVaginaVulvaBuffers

Interventions

BufferGelDRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mem Hosp of Rhode Island

Pawtucket, Rhode Island, 02860, United States

Location

Related Publications (2)

  • van De Wijgert J, Fullem A, Kelly C, Mehendale S, Rugpao S, Kumwenda N, Chirenje Z, Joshi S, Taha T, Padian N, Bollinger R, Nelson K. Phase 1 trial of the topical microbicide BufferGel: safety results from four international sites. J Acquir Immune Defic Syndr. 2001 Jan 1;26(1):21-7. doi: 10.1097/00126334-200101010-00003.

    PMID: 11176265BACKGROUND

  • Mayer KH, Peipert J, Fleming T, Fullem A, Moench T, Cu-Uvin S, Bentley M, Chesney M, Rosenberg Z. Safety and tolerability of BufferGel, a novel vaginal microbicide, in women in the United States. Clin Infect Dis. 2001 Feb 1;32(3):476-82. doi: 10.1086/318496. Epub 2001 Jan 26.

    PMID: 11170957BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

BufferGel

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Kenneth Mayer

    STUDY CHAIR

  • Kenrad Nelson

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

January 9, 2007

Record last verified: 1999-03

Locations

US(1)