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

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ClinicalTrials.gov Identifier: NCT00594373
Recruitment Status : Completed
First Posted : January 15, 2008
Last Update Posted : September 24, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Drug: Tenofovir gel Drug: Tenofovir gel placebo Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Primary Completion Date : November 2009
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions [ Time Frame: At Days 3, 7, 14, and 21 ]

Secondary Outcome Measures :
  1. Changes in antimicrobial activity of cervicovaginal secretions [ Time Frame: At Day 14 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00594373

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)
Principal Investigator: Marla Keller, MD Albert Einstein College of Medicine, Inc.
Principal Investigator: Betsy Herold, MD Albert Einstein College of Medicine, Inc.
More Information

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 ( Registry Identifier: DAIDS ES )
U01AI069551 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2008    Key Record Dates
Last Update Posted: September 24, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Infective Agents
Anti-Bacterial Agents
Antiviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents