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Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women

This study has been completed.
Sponsor:
Collaborators:
The University of Texas Medical Branch, Galveston
Oak Crest Institute of Science
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Auritec Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02431273
First received: August 4, 2014
Last updated: January 31, 2017
Last verified: January 2017
History of Changes
August 4, 2014
January 31, 2017
June 2015
December 2016   (Final data collection date for primary outcome measure)
  • Safety of the Single, Dual and Triple ARV IVRs. [ Time Frame: Days 0-21 following insertion of each IVR. ]
    Number of Participants with Adverse Events (AEs) will be recorded. Safety parameters that will be monitored for each IVR combination and the grading scale for each parameter will follow the Female Genital Grading Table for Use in Microbicide Studies. AEs not included in that table will be graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 2.0, November 2014.
  • Pharmacokinetics of the Single, Dual and Triple ARV IVRs. [ Time Frame: Days 0-21 following insertion of each IVR. ]
    Drug concentrations in plasma and cervicovaginal fluids will be evaluated for each IVR combination.
  • Safety of the Single, Dual and Triple ARV IVRs (Number of Participants with Adverse Events) [ Time Frame: Days 0-21 following insertion of each IVR. ]
    Number of Participants with Adverse Events (AEs) will be recorded. Safety parameters that will be monitored for each IVR combination and the grading scale for each parameter will follow the Female Genital Grading Table for Use in Microbicide Studies. AEs not included in that table will be graded using the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December 2004.
  • Pharmacokinetics of the Single, Dual and Triple ARV IVRs (Drug concentrations in plasma and cervicovaginal fluids) [ Time Frame: Days 0-21 following insertion of each IVR. ]
    will be evaluated for each IVR combination.
Complete list of historical versions of study NCT02431273 on ClinicalTrials.gov Archive Site
Acceptability of the IVRs. [ Time Frame: Days 0-21 following insertion of each IVR. ]
Acceptability and comfort will be assessed.
Acceptability (Using standard grading scales developed for IVRs) [ Time Frame: Days 0-21 following insertion of each IVR. ]
Using standard grading scales developed for IVRs, the acceptability and comfort of the rings will be assessed.
Not Provided
Not Provided
 
Safety and Pharmacokinetic Study of HIV Prophylaxis Using Antiretroviral Intravaginal Rings in Healthy Women
Open-Label Safety and Pharmacokinetic Study of Single (TDF), Dual (TDF-FTC), and Triple ARV IVR (TDF-FTC-MVC) in Healthy Women
This study will evaluate the hypothesis that intravaginal rings (IVRs) can safely and in a sustained fashion, deliver the antiretroviral (ARV) drugs - tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), and maraviroc (MVC), in healthy women when used in the following drug combinations: 1) TDF ("Single" IVR); 2) TDF-FTC ("Dual" IVR) and; 3) TDF-FTC-MVC ("Triple" IVR).
The broad long term goal of this project is to empower women to protect themselves from HIV through woman-controlled sustained local delivery of ARTs via intravaginal rings. The short-term general investigational plan is to evaluate IVRs releasing TDF, TDF-FTC and TDF-FTC-MVC in healthy women for up to 7 days in an open-label study to determine safety and drug concentrations in plasma and cervicovaginal lavage and secretions. Additional exploratory studies will be considered and planned based in part on the results obtained in this study. The long-term investigational plan is to evaluate the safety and efficacy of sustained release TDF, TDF-FTC and TDF-FTC-MVC for their ability to decrease HIV transmission to vulnerable women.
Interventional
Early Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
Human Immunodeficiency Virus (HIV) Prophylaxis
  • Drug: TDF IVR
    Other Name: Single IVR
  • Drug: TDF-FTC IVR
    Other Name: Dual IVR
  • Drug: TDF-FTC-MVC IVR
    Other Name: Triple IVR
  • Experimental: TDF (Single IVR)
    All subjects will be asked to wear "Single" (TDF) IVRs for 7 days.
    Intervention: Drug: TDF IVR
  • Experimental: TDF-FTC (Dual IVR)
    If the TDF IVR is determined as safe, study participants will be asked to replace it with "Dual" (TDF-FTC) IVRs for 7 days. There will be follow-up visit between removal of a single IVR and replacing it with a dual IVR.
    Intervention: Drug: TDF-FTC IVR
  • Experimental: TDF-FTC-MVC (Triple IVR)
    If the TDF-FTC IVR is determined as safe, study participants will be asked to replace them with "Triple" (TDF-FTC-MVC) IVRs for 7 days. There will be follow-up visit between removal of a dual IVR and replacing it with a triple IVR.
    Intervention: Drug: TDF-FTC-MVC IVR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
December 2016
December 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Provides written informed consent
  • Healthy female 18-45 years of age
  • HIV negative per subject report and results of screening examination
  • Negative for sexually transmitted diseases in the past 3 months and at screening exam
  • No history of genital herpes simplex I or II per subject report
  • Currently using contraception with plans to continue throughout the study duration or having sex with females only
  • Pre-menopausal with a regular menstrual cycle with at least 21 days between menses and no history of intermenstrual bleeding or with suppressed menstrual cycle by hormonal contraception such as Depo-Provera or continuous oral contraceptive agents
  • Subjects must agree to abstain from vaginal, anal, and oral sex throughout the first week of each dosing period and then use condoms for vaginal/rectal intercourse until after the final visit for use of each IVR
  • Subjects must agree to not douche or use any vaginal product other than the Single, Dual and Triple ARV IVRs, including lubricants, feminine hygiene products, and vaginal drying agents throughout the dosing period and until after the final visit
  • Subjects must agree to blood draws and vaginal exams throughout the course of the study

Exclusion Criteria:

  • HIV positive by subject report or results of screening examination
  • Positive history for autoimmune disease
  • Abnormal genital exam defined as grade 1 or higher adverse event by DAIDS genital AE grading table
  • Abnormal ALT or AST or Hepatitis B infection
  • Active vaginal infection as determined by site IoR
  • Abnormal renal function (defined as a creatinine clearance of <50mL/min/1.73 m2)
  • Pregnant or less than 6 months post-partum or current lactation
  • Current use of an IVR (i.e., Nuvaring, Estring, Femring)
  • History of TDF, FTC, and MVC use and/or adverse reaction to any of these drugs
  • History of adverse reaction to silicone
  • History of toxic shock syndrome
  • Currently receiving chemotherapy or immunosuppressive agents
  • Use of investigative drugs within 30 days or 5 half-lives
  • Currently using or suspected to be using non-therapeutic injection drugs
Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02431273
ARV-IVR 01
2R44HD075636-02 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Auritec Pharmaceuticals
Auritec Pharmaceuticals
  • The University of Texas Medical Branch, Galveston
  • Oak Crest Institute of Science
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Kathleen L Vincent, MD University of Texas Medical Branch (UTMB)
Auritec Pharmaceuticals
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP