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CompletedNCT00850837Updated Dec 3, 2013

Safety of Acidform Lubricant in HIV-Uninfected Women

A Phase 1 interventional study of Acidform Lubricant and HEC gel in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-03.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • HIV Infections

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Keywords

  • Microbicide
  • HIV Seronegativity
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 35 is below the median of 120 across 4,201 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
35 participants (actual)

Study arms

  • Experimental
    1

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

    Drug: Acidform Lubricant

  • Placebo comparator
    2

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

    Drug: HEC gel

Interventions

  • DrugAcidform Lubricant

    5 g application of acid buffered gel (pH = 3.5)

    Also known as: Amphora

  • DrugHEC gel

    5 g application of hydroxyethylcellulose gel

06

What researchers measure

Primary outcomes

  1. Measured endogenous antimicrobial activity

    Time frame: Throughout study

  2. Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL

    Time frame: Throughout study

Secondary outcomes

  1. Extent and duration of buffering measured by vaginal pH

    Time frame: Prior to and 2 hours after first application

  2. Changes in epithelial integrity after Acidform and HEC application

    Time frame: Throughout study

  3. Changes in vaginal flora following Acidform and HEC application

    Time frame: Throughout study

  4. Antiviral activity in CVL following Acidform and HEC application

    Time frame: Throughout study

07

Study locations

1 site
  • Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS
    Bronx, New York 10461, United States
08

References and documents

Publications

  • 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. PubMed 19143675 ↗
  • 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. PubMed 18562985 ↗
  • 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. PubMed 18080349 ↗
  • 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. PubMed 23056520 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00850837
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Feb 25, 2009
Start date
Feb 2009
Last update
Dec 3, 2013

Study contacts

Marla Keller, MD
principal investigator · Albert Einstein College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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