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

Sponsor:	National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00594373

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 I

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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Adenine Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

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 ]

Estimated Enrollment:	30
Study Start Date:	October 2008
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (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

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

Locations

United States, New York
Montefiore Medical Center, 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
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:

Bateman C. Tenofovir gel--the new HIV prevention 'banker'? S Afr Med J. 2007 Jul;97(7):496, 498. Review. No abstract available.

Mayer KH, Maslankowski LA, Gai F, El-Sadr WM, Justman J, Kwiecien A, Masse B, Eshleman SH, Hendrix C, Morrow K, Rooney JF, Soto-Torres L; HPTN 050 Protocol Team. Safety and tolerability of tenofovir vaginal gel in abstinent and sexually active HIV-infected and uninfected women. AIDS. 2006 Feb 28;20(4):543-51.

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

Keller MJ, Madan RP, Torres NM, Fazzari MJ, Cho S, Kalyoussef S, Shust G, Mesquita PM, Louissaint N, Chen J, Cohen HW, Diament EC, Lee AC, Soto-Torres L, Hendrix CW, Herold BC. A randomized trial to assess anti-HIV activity in female genital tract secretions and soluble mucosal immunity following application of 1% tenofovir gel. PLoS One. 2011 Jan 25;6(1):e16475.

Responsible Party:	Rona Siskind, DAIDS
ClinicalTrials.gov Identifier:	NCT00594373 History of Changes
Other Study ID Numbers:	TFV 010, U01 AI069551
Study First Received:	January 2, 2008
Last Updated:	May 11, 2010
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
Tenofovir

Tenofovir disoproxil
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on February 09, 2012