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Safety of Acidform Lubricant in HIV-Uninfected Women

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acidform Lubricant
HEC gel
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Microbicide, HIV Seronegativity

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Normal menstrual history with regular cycles and with a minimum of 21 days between menses
  • Low risk for HIV/STI infection. More information on this criterion can be found in the protocol.
  • Agree to abstain from vaginal and anal intercourse and to not use vaginal products within 48 hours prior to study entry and for the duration of the study

Exclusion Criteria:

  • HIV-infected
  • Menopausal
  • Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry
  • Menstruating at screening or enrollment visits
  • Urinary tract infection at screening
  • Positive chlamydia, gonorrhea, or trichomonas result at screening
  • Abnormal Pap smear
  • Clinically detectable genital abnormality. More information on this criterion can be found in the protocol.
  • Currently participating in a research study of other vaginal products
  • History of intermenstrual bleeding within 3 months prior to study entry
  • Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts within 6 months prior to study entry
  • Received treatment for Candida, bacterial vaginosis, or urinary tract infection within 1 month prior to study entry
  • Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents, and sex toys within 48 hours prior to study entry
  • Vaginal or anal intercourse during the 48 hours prior to study entry
  • Oral antibiotics within 7 days of study entry
  • Pregnant, less than 6 months postpartum, or breastfeeding

Sites / Locations

  • Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Participants will apply Acidform lubricant twice daily for 14 consecutive days between menses

Participants will apply HEC gel twice daily for 14 consecutive days between menses

Outcomes

Primary Outcome Measures

Measured endogenous antimicrobial activity
Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL

Secondary Outcome Measures

Extent and duration of buffering measured by vaginal pH
Changes in epithelial integrity after Acidform and HEC application
Changes in vaginal flora following Acidform and HEC application
Antiviral activity in CVL following Acidform and HEC application

Full Information

First Posted
February 24, 2009
Last Updated
December 2, 2013
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00850837
Brief Title
Safety of Acidform Lubricant in HIV-Uninfected Women
Official Title
Safety of Acidform Lubricant (Amphora) in Women at Low Risk for HIV-1 Infection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease pathogens. In the future, topical microbicides may be applied vaginally to prevent both acquisition and transmission of HIV and other sexually transmitted infections (STIs). The purpose of this study is to compare the safety of daily applications of Acidform lubricant and HEC gel in healthy women at low risk for HIV infection and assess the effect of a microbicide candidate on the natural immunity women have to STI pathogens.
Detailed Description
A new approach to HIV prevention currently being studied is the use of topical microbicides. This study will measure the mucosal response to daily intravaginal applications of Acidform lubricant and HEC gel in two groups of healthy women at low risk for HIV infection. The duration of this study for each participant is 3 weeks. Study participants will be randomly assigned to one of two study groups. Group 1 participants will apply Acidform lubricant twice daily for 14 consecutive days between menses. Group 2 participants will apply HEC gel for 14 consecutive days between menses. After screening and study entry, study visits will occur on Days 7, 14, and 21. Study entry will occur 2 to 6 days following the menses and within 45 days of screening. Medical and sexual history, a pelvic exam, cervicovaginal lavage sample collection, blood collection, vaginal pH testing, STI testing, and adverse effect reporting will occur at all visits. Cytobrush collection, vaginal swab, and cervical biopsy will occur at selected visits. All participants will be asked to complete a diary throughout the study; this diary will be reviewed at all study visits. A Pap smear will be obtained at screening if documentation of a negative Pap smear result within the last year is not available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Microbicide, HIV Seronegativity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will apply Acidform lubricant twice daily for 14 consecutive days between menses
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Participants will apply HEC gel twice daily for 14 consecutive days between menses
Intervention Type
Drug
Intervention Name(s)
Acidform Lubricant
Other Intervention Name(s)
Amphora
Intervention Description
5 g application of acid buffered gel (pH = 3.5)
Intervention Type
Drug
Intervention Name(s)
HEC gel
Intervention Description
5 g application of hydroxyethylcellulose gel
Primary Outcome Measure Information:
Title
Measured endogenous antimicrobial activity
Time Frame
Throughout study
Title
Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL
Time Frame
Throughout study
Secondary Outcome Measure Information:
Title
Extent and duration of buffering measured by vaginal pH
Time Frame
Prior to and 2 hours after first application
Title
Changes in epithelial integrity after Acidform and HEC application
Time Frame
Throughout study
Title
Changes in vaginal flora following Acidform and HEC application
Time Frame
Throughout study
Title
Antiviral activity in CVL following Acidform and HEC application
Time Frame
Throughout study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Normal menstrual history with regular cycles and with a minimum of 21 days between menses Low risk for HIV/STI infection. More information on this criterion can be found in the protocol. Agree to abstain from vaginal and anal intercourse and to not use vaginal products within 48 hours prior to study entry and for the duration of the study Exclusion Criteria: HIV-infected Menopausal Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry Menstruating at screening or enrollment visits Urinary tract infection at screening Positive chlamydia, gonorrhea, or trichomonas result at screening Abnormal Pap smear Clinically detectable genital abnormality. More information on this criterion can be found in the protocol. Currently participating in a research study of other vaginal products History of intermenstrual bleeding within 3 months prior to study entry Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts within 6 months prior to study entry Received treatment for Candida, bacterial vaginosis, or urinary tract infection within 1 month prior to study entry Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents, and sex toys within 48 hours prior to study entry Vaginal or anal intercourse during the 48 hours prior to study entry Oral antibiotics within 7 days of study entry Pregnant, less than 6 months postpartum, or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marla Keller, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19143675
Citation
Anderson DJ, Williams DL, Ballagh SA, Barnhart K, Creinin MD, Newman DR, Bowman FP, Politch JA, Duerr AC, Jamieson DJ. Safety analysis of the diaphragm in combination with lubricant or acidifying microbicide gels: effects on markers of inflammation and innate immunity in cervicovaginal fluid. Am J Reprod Immunol. 2009 Feb;61(2):121-9. doi: 10.1111/j.1600-0897.2008.00670.x.
Results Reference
background
PubMed Identifier
18562985
Citation
Behets FM, Turner AN, Van Damme K, Rabenja NL, Ravelomanana N, Swezey TA, Bell AJ, Newman DR, Williams DL, Jamieson DJ; Mad STI Prevention Group. Vaginal microbicide and diaphragm use for sexually transmitted infection prevention: a randomized acceptability and feasibility study among high-risk women in Madagascar. Sex Transm Dis. 2008 Sep;35(9):818-26. doi: 10.1097/OLQ.0b013e318175d8ab.
Results Reference
background
PubMed Identifier
18080349
Citation
Williams DL, Newman DR, Ballagh SA, Creinin MD, Barnhart K, Weiner DH, Bell AJ, Jamieson DJ. Phase I safety trial of two vaginal microbicide gels (Acidform or BufferGel) used with a diaphragm compared to KY jelly used with a diaphragm. Sex Transm Dis. 2007 Dec;34(12):977-84. doi: 10.1097/olq.0b013e31813347e9.
Results Reference
background
PubMed Identifier
23056520
Citation
Keller MJ, Carpenter CA, Lo Y, Einstein MH, Liu C, Fredricks DN, Herold BC. Phase I randomized safety study of twice daily dosing of acidform vaginal gel: candidate antimicrobial contraceptive. PLoS One. 2012;7(10):e46901. doi: 10.1371/journal.pone.0046901. Epub 2012 Oct 8.
Results Reference
derived

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Safety of Acidform Lubricant in HIV-Uninfected Women

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