Safety of Acidform Lubricant in HIV-Uninfected Women - Full Text View

Sponsored by:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00850837

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Drug: Acidform Lubricant Drug: HEC gel	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Official Title:	Safety of Acidform Lubricant (Amphora) in Women at Low Risk for HIV-1 Infection

Resource links provided by NLM:

MedlinePlus related topics: AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:

Measured endogenous antimicrobial activity [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Measured levels of mediators of host defense, including defensins, cytokines, and chemokines in CVL [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Extent and duration of buffering measured by vaginal pH [ Time Frame: Prior to and 2 hours after first application ] [ Designated as safety issue: No ]
Changes in epithelial integrity after Acidform and HEC application [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Changes in vaginal flora following Acidform and HEC application [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Antiviral activity in CVL following Acidform and HEC application [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:

36

Arms	Assigned Interventions
1: Experimental Participants will apply Acidform lubricant twice daily for 14 consecutive days between menses	Drug: Acidform Lubricant 5 g application of acid buffered gel (pH = 3.5)
2: Placebo Comparator Participants will apply HEC gel twice daily for 14 consecutive days between menses	Drug: HEC gel 5 g application of hydroxyethylcellulose gel

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 30 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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00850837

Locations

United States, New York
Albert Einstein College of Medicine
Bronx, New York, United States, 10461

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator:

Marla Keller, MD

Albert Einstein College of Medicine of Yeshiva University

More Information

Additional Information:

Click here for more information about HEC gel This link exits the ClinicalTrials.gov site

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.

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.

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.

Responsible Party:	DAIDS ( Rona Siskind )
Study ID Numbers:	AF 020, U01 AI069551
Study First Received:	February 24, 2009
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00850837 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Microbicide
HIV Seronegativity

Study placed in the following topic categories:

Virus Diseases
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

Communicable Diseases
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Immune System Diseases
Acquired Immunodeficiency Syndrome
Infection

Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections

ClinicalTrials.gov processed this record on September 10, 2009