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Safety of Acidform Lubricant in HIV-Uninfected Women

This study is currently recruiting participants.
Verified October 2012 by National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00850837
First received: February 24, 2009
Last updated: October 26, 2012
Last verified: October 2012
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Acidform Lubricant (Amphora) in Women at Low Risk for HIV-1 Infection

Resource links provided by NLM:

MedlinePlus related topics: HIV/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
Study Start Date: February 2009
Arms Assigned Interventions
Experimental: 1
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)
Other Name: Amphora
Placebo Comparator: 2
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 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.

  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 Recruiting
Bronx, New York, United States, 10461
Contact: Anna Lee     718-430-3253     ann.lee@einstein.yu.edu    
Contact: Erin Carroll, NP     718-430-3061     erin.carroll@einstein.yu.edu    
Principal Investigator: Marla Keller, MD            
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:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00850837     History of Changes
Other Study ID Numbers: AF 020, U01 AI069551
Study First Received: February 24, 2009
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on May 16, 2013