Safety of Acidform Lubricant in HIV-Uninfected Women

NCT00850837 | Completed Phase 1 DMC

• 4 other identifiers: Keller 069551 AF020U01AI06955110740AF 020
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Microbicide; HIV Seronegativity

Outcome Measures

Primary Outcomes (2)

• Measured endogenous antimicrobial activity

  Throughout study

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

  Throughout study

Secondary Outcomes (4)

• Extent and duration of buffering measured by vaginal pH

  Prior to and 2 hours after first application

• Changes in epithelial integrity after Acidform and HEC application

  Throughout study

• Changes in vaginal flora following Acidform and HEC application

  Throughout study

• Antiviral activity in CVL following Acidform and HEC application

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

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

Drug: Acidform Lubricant

2

PLACEBO COMPARATOR

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

Drug: HEC gel

Interventions

Acidform Lubricant DRUG

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

Also known as: Amphora

1

HEC gel DRUG

5 g application of hydroxyethylcellulose gel

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

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

The Bronx, New York, 10461, United States

Location

Related Publications (4)

• 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.

  PMID: 19143675 BACKGROUND

• 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.

  PMID: 18562985 BACKGROUND

• 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.

  PMID: 18080349 BACKGROUND

• 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.

  PMID: 23056520 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Marla Keller, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2009
• First Posted: February 25, 2009
• Study Start: February 1, 2009
• Last Updated: December 3, 2013

Record last verified: 2013-12

Locations

US (1)