NCT01810315

Brief Summary

Purpose of the study is to assess tenofovir (TFV) PK and PD endpoints, cervicovaginal safety parameters, susceptibility to HIV-1 infection, and objective measures of vaginal applicator use in premenopausal and postmenopausal women.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 10, 2015

Status Verified

April 1, 2015

Enrollment Period

1.1 years

First QC Date

March 11, 2013

Last Update Submit

April 9, 2015

Conditions

HIV Prevention

Outcome Measures

Primary Outcomes (2)

  • Concentrations of tenofovir in plasma, vaginal aspirate, and genital tissue

    3 hours after dosing

  • Concentrations of TFV-DP in genital tissue

    3 hours after dosing

Study Arms (4)

Baseline

NO INTERVENTION

Premenopausal women will undergo baseline sampling in each the follicular and luteal phase. Postmenopausal women will undergo baseline sampling one time.

TFV 1% Gel

EXPERIMENTAL

Participants will vaginally insert 1 applicator of TFV gel followed by a 2nd applicator 2 hours later. Each applicator contains 4.4 gm of TFV 1% gel. Premenopausal women will undergo sampling after TFV gel use in each the follicular and luteal phase. Postmenopausal women will undergo sampling after TFV gel use one time.

Drug: TFV 1% gel

Estradiol Vaginal Cream

EXPERIMENTAL

Post menopausal women only: Participants will insert 2 grams of estradiol cream into the vagina every night for 14 days and then one gram of estradiol cream into the vagina every other night

Drug: Estradiol vaginal cream

TFV 1% gel and estradiol cream

EXPERIMENTAL

Postmenopausal women only: Participants will vaginally insert 1 applicator of TFV gel followed by a 2nd applicator 2 hours later. Each applicator contains 4.4 gm of TFV 1% gel. In addition, participants will one gram of estradiol cream into the vagina every other night.

Drug: TFV 1% gelDrug: Estradiol vaginal cream

Interventions

TFV 1% gelDRUG
TFV 1% GelTFV 1% gel and estradiol cream
Estradiol vaginal creamDRUG
Estradiol Vaginal CreamTFV 1% gel and estradiol cream

Eligibility Criteria

Age21 Years - 89 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In good healthsignificant systemic disease
  • Not at risk of an STI, meaning: In a monogamous heterosexual or same sex relationship for at least the last four months with a partner who is not known to be HIV positive and has no known risks for STIs OR sexually abstinent
  • Willing and able to comply with study procedures
  • Normal Pap smear (by written report) in the past year.
  • to-45 years of age
  • Not at risk for pregnancy, meaning:
  • Regular menstrual cycles (every 24 - 35 days)
  • Luteal phase P level of greater than or equal to 3 ng/ml
  • years of age OR both ovaries removed at least 30 days prior to Visit 1
  • No menstrual periods/vaginal bleeding in the past 12 months OR both ovaries removed at least 30 days prior to Visit 1
  • FSH level of greater than or equal to 20 MIU/ml

You may not qualify if:

  • Clinically significant history of an abnormal Pap smear in the past year
  • Surgery or biopsy of the vagina or cervix within 30 days
  • Current STI or lower genital tract infection
  • Current use of chronic immunosuppressants
  • Current presence of vulvar, anal and/or vaginal genital warts
  • Current tobacco use of any amount
  • History of sensitivity/allergy to any component of the study product, topical anesthetic, or allergy to silver nitrate and/or Monsel's solution
  • Known bleeding disorder that could lead to prolonged or continuous bleeding
  • Grade 1 or higher laboratory abnormality, per the August 2009 update of the DAIDS Table for Grading the Severity of Adverse Events
  • Systemic use in the last two weeks or anticipated use during the study of any of the following: corticosteroids, antibiotics, anticoagulants or other drugs known to prolong bleeding and/or clotting, antifungals, antivirals or antiretrovirals.
  • Investigator discretion
  • Current participation in any other drug or device study
  • Use of DMPA in last six months
  • Use of any other hormonal contraceptive method without 2 subsequent, normal menses since stopping hormonal contraceptives
  • Current use of copper IUD
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Research Center, Eastern Virginia Medical School

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Interventions

Gels

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

March 13, 2013

Study Start

September 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

April 10, 2015

Record last verified: 2015-04

Locations

US(1)