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Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Tenofovir gel
Sponsored by
CONRAD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for HIV Infections focused on measuring HIV prevention, Microbicides, Pharmacokinetics, vaginal biopsies

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Must be between 18-45 years old, inclusive
  • Must be in general good health by volunteer history without any clinically significant systemic disease (including liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease)
  • Must have regular menstrual cycles (minimum of 26 and maximum of 38 days)
  • Must be at least 2 months since last pregnancy outcome and have had at least two spontaneous menses
  • Must abstain from sexual activity and use of intravaginal products for 72 hours prior to the start of the single-dose phase and multi-dose phase, for at least one week following vaginal biopsies and for the duration of the study phases
  • Willingness to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol

Exclusion Criteria:

  • Currently pregnant or at risk for pregnancy (may be using Paragard® IUD, effective barrier method, female sterilization or abstinence, or be sexually active with a vasectomized partner)
  • Currently breastfeeding or planning to breastfeed during the course of the study
  • Use of any hormonal contraceptives within 30 days of enrollment
  • Use of Depo-Provera within 120 days of enrollment History of abnormal Pap smear (by volunteer history) that has not been evaluated and treated, if indicated, according to standard guidelines
  • Current vaginal or urinary tract infection
  • Positive test for Neisseria gonorrhea or Chlamydia trachomatis at the time of screening
  • Positive wet mount for Trichomonas vaginalis at the time of screening or enrollment
  • Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection
  • Current or past use of any anti-retroviral therapies including but not limited to systemic tenofovir (Viread®)
  • Current or recent drug or alcohol abuse
  • Current or anticipated use of drugs on a daily basis that may reduce renal function (e.g. acyclovir or ibuprofen) or liver function (e.g. tylenol)
  • HIV positive at the time of screening
  • Hepatitis B surface antigen (HBsAg) positive at the time of screening
  • Grade 1 or higher serum chemistry or complete blood count abnormality in accordance with DAIDS toxicity table values
  • Abnormal finding on laboratory or physical examination or a medical condition which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data
  • Participation in any other research study in the 30 days prior to screening and/or plans to participate in any other research study during entire study duration

Sites / Locations

  • University of Pittsburgh Medical Center
  • Advances in Health, Inc
  • Profamilia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Twice daily

Once daily

Arm Description

Tenofovir gel intravaginal twice daily for 14 days

Tenofovir gel intravaginal once daily for 14 days

Outcomes

Primary Outcome Measures

Concentration of tenofovir in local genital tract compartments (intraluminal, mononuclear cells and vaginal tissue levels). Concentration (Cmax) and time of maximum concentration (Tmax) of tenofovir in the systemic compartment.

Secondary Outcome Measures

Full Information

First Posted
November 19, 2007
Last Updated
May 27, 2008
Sponsor
CONRAD
Collaborators
International Partnership for Microbicides, Inc., Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00561496
Brief Title
Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel
Official Title
Single Dose and 14-Day Once or Twice-Daily Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
CONRAD
Collaborators
International Partnership for Microbicides, Inc., Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multi-center, pharmacokinetic study involving a single-dose phase, a wash out phase and a two-week once or twice-daily dosing phase for each of 49 volunteers. In the single-dose phase, each volunteer will apply the single dose in the clinic. Participants will be randomized to have cervicovaginal samples and biopsies collected at one of seven time-points [0.5, 1, 2, 4, 6, 8, and 24 hour(s)] after the single-dose. Blood samples will be drawn at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) after the single-dose. In the two-week phase, the study supplies will be distributed and the participants will be randomized to apply each dose either once or twice-daily for two weeks. At the one week follow-up visit a blood sample will be drawn prior to the morning dose to obtain a trough value and cervicovaginal samples will be collected four hours after the morning dose. At the two week follow-up visit blood samples will be drawn prior to the morning dose to obtain a trough value and then at 0.5, 1, 2, 4, 6, 8, and 24 hour(s) from the final morning dose. Participants will be randomized to have cervicovaginal samples and biopsies collected at either 4, 8 or 24 hours after the final morning dose. Up to 10 participants who have completed the first two phases of the study, will be asked to participate in a third phase to have cervicovaginal samples, biopsies and blood samples collected 12 hours after a single-dose.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV prevention, Microbicides, Pharmacokinetics, vaginal biopsies

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Twice daily
Arm Type
Other
Arm Description
Tenofovir gel intravaginal twice daily for 14 days
Arm Title
Once daily
Arm Type
Other
Arm Description
Tenofovir gel intravaginal once daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Tenofovir gel
Other Intervention Name(s)
9-[(R)-2-(phosphonomethoxy)propyl] adenine or PMPA
Intervention Description
Intravaginal (4grams)single dose followed by fourteen days
Primary Outcome Measure Information:
Title
Concentration of tenofovir in local genital tract compartments (intraluminal, mononuclear cells and vaginal tissue levels). Concentration (Cmax) and time of maximum concentration (Tmax) of tenofovir in the systemic compartment.
Time Frame
Single dose; two weeks (after once or twice-daily vaginal administration)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must be between 18-45 years old, inclusive Must be in general good health by volunteer history without any clinically significant systemic disease (including liver disease/hepatitis, gastrointestinal disease, kidney disease, thyroid disease, osteoporosis or bone disease) Must have regular menstrual cycles (minimum of 26 and maximum of 38 days) Must be at least 2 months since last pregnancy outcome and have had at least two spontaneous menses Must abstain from sexual activity and use of intravaginal products for 72 hours prior to the start of the single-dose phase and multi-dose phase, for at least one week following vaginal biopsies and for the duration of the study phases Willingness to give voluntary consent, sign an informed consent form and comply with study procedures as required by the protocol Exclusion Criteria: Currently pregnant or at risk for pregnancy (may be using Paragard® IUD, effective barrier method, female sterilization or abstinence, or be sexually active with a vasectomized partner) Currently breastfeeding or planning to breastfeed during the course of the study Use of any hormonal contraceptives within 30 days of enrollment Use of Depo-Provera within 120 days of enrollment History of abnormal Pap smear (by volunteer history) that has not been evaluated and treated, if indicated, according to standard guidelines Current vaginal or urinary tract infection Positive test for Neisseria gonorrhea or Chlamydia trachomatis at the time of screening Positive wet mount for Trichomonas vaginalis at the time of screening or enrollment Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or vesicles suspicious for a sexually transmitted infection Current or past use of any anti-retroviral therapies including but not limited to systemic tenofovir (Viread®) Current or recent drug or alcohol abuse Current or anticipated use of drugs on a daily basis that may reduce renal function (e.g. acyclovir or ibuprofen) or liver function (e.g. tylenol) HIV positive at the time of screening Hepatitis B surface antigen (HBsAg) positive at the time of screening Grade 1 or higher serum chemistry or complete blood count abnormality in accordance with DAIDS toxicity table values Abnormal finding on laboratory or physical examination or a medical condition which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data Participation in any other research study in the 30 days prior to screening and/or plans to participate in any other research study during entire study duration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Schwartz, MD
Organizational Affiliation
CONRAD
Official's Role
Study Director
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Advances in Health, Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Profamilia
City
Santo Domingo
Country
Dominican Republic

12. IPD Sharing Statement

Citations:
PubMed Identifier
22039430
Citation
Schwartz JL, Rountree W, Kashuba AD, Brache V, Creinin MD, Poindexter A, Kearney BP. A multi-compartment, single and multiple dose pharmacokinetic study of the vaginal candidate microbicide 1% tenofovir gel. PLoS One. 2011;6(10):e25974. doi: 10.1371/journal.pone.0025974. Epub 2011 Oct 19.
Results Reference
derived

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Pharmacokinetic Study of the Vaginal Microbicide Agent 1% Tenofovir Gel

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