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Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00594373
First received: January 2, 2008
Last updated: September 23, 2013
Last verified: September 2013
History of Changes
  Purpose

Topical microbicides, substances that kill microbes, are being studied to prevent sexual transmission of HIV and other disease-causing agents. 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 assess whether there is a measurable response to daily applications of a topical microbicide, 1% tenofovir gel, in women at low risk for HIV infection.


Condition Intervention Phase
HIV Infections
 Drug: Tenofovir gel
Drug: Tenofovir gel placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Repeated Applications of Tenofovir Gel on Mucosal Mediators of Immunity and Intrinsic Antimicrobial Activity of Cervicovaginal Secretions 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:
  • Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions [ Time Frame: At Days 3, 7, 14, and 21 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Changes in antimicrobial activity of cervicovaginal secretions [ Time Frame: At Day 14 ] [ Designated as safety issue: Yes ]
Enrollment: 30
Study Completion Date: April 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Application of 1% tenofovir gel for 14 consecutive days between menses
 Drug: Tenofovir gel
1 gm/100 ml of 1% tenofovir gel vaginally daily
Other Names:
  • TFV
  • 9-(2-[Phosphonomethoxy]propyl)adenine
Placebo Comparator: 2
Application of 1% tenofovir placebo gel for 14 consecutive days between menses
 Drug: Tenofovir gel placebo
1 gm/100 ml of placebo gel vaginally daily

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 1% tenofovir gel versus placebo in two groups of women at low risk for HIV infection.

The duration of this study for each participant is 21 days. Study participants will be randomly assigned to one of two study groups. Group 1 participants will apply 1% tenofovir gel daily for 14 consecutive days between menses. Group 2 participants will apply placebo gel for 14 consecutive days between menses.

Study visits will occur on Days 3, 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. 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
  • Sexually abstinent or in a stable, mutually monogamous relationship with a partner who is HIV uninfected
  • Agree to abstain from sexual intercourse and to not use vaginal products within 48 hours of study entry and for the duration of the study

Exclusion Criteria:

  • HIV infected
  • Sexually transmitted infection within 6 months of study entry
  • Use of nontherapeutic intravenous drugs within 12 months of study entry
  • Menopausal
  • Currently using hormonal contraception or have used hormonal contraception within 2 months of study entry
  • Menstruating at screening or enrollment visits
  • Positive urine culture
  • 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.
  • History of toxic shock syndrome or a history of symptoms suggesting toxic shock syndrome
  • History of intermenstrual bleeding within 3 months of study entry
  • Previous gynecologic surgery or have received treatment for syphilis, genital herpes, chlamydia, gonorrhea, trichomonas, or genital warts within 6 months of study entry
  • Received treatment for Candida, bacterial vaginosis, or urinary tract infection within 1 month of study entry
  • Have douched or used vaginal products, including lubricants, feminine hygiene products, vaginal drying agents, and sex toys within 48 hours of study entry
  • Acute or chronic hepatitis B virus infection
  • Liver or kidney abnormalities
  • Oral antibiotics within 7 days of study entry
  • Pregnant, less than 6 months postpartum, or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594373

Locations
United States, New York
Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS
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
Principal Investigator: Betsy Herold, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

Additional Information:
Click here for more information about tenofovir  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: NCT00594373     History of Changes
Other Study ID Numbers: TFV 010, 10443, U01 AI069551
Study First Received: January 2, 2008
Last Updated: September 23, 2013
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:
Tenofovir
Tenofovir disoproxil
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antiviral Agents
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015