search
Back to results

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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tenofovir gel
Tenofovir gel placebo
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Microbicide, HIV Seronegativity

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Application of 1% tenofovir gel for 14 consecutive days between menses

Application of 1% tenofovir placebo gel for 14 consecutive days between menses

Outcomes

Primary Outcome Measures

Changes in cytokines, chemokines, and other mediators of innate immunity through examination of cervicovaginal secretions

Secondary Outcome Measures

Changes in antimicrobial activity of cervicovaginal secretions

Full Information

First Posted
January 2, 2008
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00594373
Brief Title
Interventional Study of Mucosal and Antimicrobial Responses to Repeated Vaginal Applications of Tenofovir Gel in HIV Uninfected Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Microbicide, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Application of 1% tenofovir gel for 14 consecutive days between menses
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Application of 1% tenofovir placebo gel for 14 consecutive days between menses
Intervention Type
Drug
Intervention Name(s)
Tenofovir gel
Other Intervention Name(s)
TFV, 9-(2-[Phosphonomethoxy]propyl)adenine
Intervention Description
1 gm/100 ml of 1% tenofovir gel vaginally daily
Intervention Type
Drug
Intervention Name(s)
Tenofovir gel placebo
Intervention Description
1 gm/100 ml of placebo gel vaginally daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Changes in antimicrobial activity of cervicovaginal secretions
Time Frame
At Day 14

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marla Keller, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Betsy Herold, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine - East Campus GCRC (Herold) Non-Network CRS
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17805450
Citation
Bateman C. Tenofovir gel--the new HIV prevention 'banker'? S Afr Med J. 2007 Jul;97(7):496, 498. No abstract available.
Results Reference
background
PubMed Identifier
16470118
Citation
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. doi: 10.1097/01.aids.0000210608.70762.c3.
Results Reference
background
PubMed Identifier
21283552
Citation
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. doi: 10.1371/journal.pone.0016475.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs