Exploratory Pharmacodynamic Study of Tenofovir-Based Products
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02722343|
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : September 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|HIV||Drug: Tenofovir intravaginal ring Drug: Truvada||Phase 1|
This study will compare an investigational intravaginal ring containing tenofovir (TFV) with an FDA approved medication in tablet form called Truvada®. It will assess and compare the ability of the tablet and intravaginal ring to prevent HIV transmission (human immunodeficiency virus, the virus that causes AIDS).
The study will enroll healthy, non-pregnant, HIV negative, premenopausal women (aged 18-50, with regular menstrual cycles) who are not at risk of pregnancy.
The enrollment goal is for 20 participants to complete the study.
Participants will be assigned to use one of the study products: oral tablet or intravaginal ring. Participants will take the oral tablet each day for 14 days or wear the intravaginal ring all day and night for 14 days/nights. Blood, genital fluid samples and genital tissue samples (biopsies) will be taken at two visits. These sample collections will take place before and after use of the assigned study product. The samples will be tested to:
- Determine the levels of drug in the blood and genital tissue samples
- See if the samples taken from the vagina and cervix after use of study product, provides protection from HIV in the laboratory
- Ensure that the laboratory test used to measure HIV infection in the samples performs well when used repeatedly.
In addition this study will also evaluate the returned TFV rings to see whether they were used as instructed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Exploratory Pharmacodynamic Study of Tenofovir-Based Products|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Tenofovir intravaginal ring
The tenofovir intravaginal ring (TFV IVR) is 55.0 mm in diameter, consisting of a single segment of polyurethane tubing with an outer diameter of 5.5 mm and filled with white TFV-containing paste. The IVR delivers 8-10mg/day of TFV.
Drug: Tenofovir intravaginal ring
The participant will wear the intravaginal ring consecutively for 14 days and nights. Following study product use and at study visit 4, blood and genital tract samples will be taken (to include cervico-vaginal fluid and tissue)
Active Comparator: Truvada oral tablets
The tablets contain 200mg emtricitabine combined with 300mg tenofovir disoproxil fumarate (300mg). The tablets are commercially available as Truvada. The tablets are blue, capsule-shaped, film-coated, debossed with "GILEAD" on one side and with "701" on the other side
The participant will take the tablet for 14 days. taking one tablet each morning. Following study product use and at study visit 4, blood and genital tract samples will be taken (to include cervico-vaginal fluid and tissue)
Other Name: Emtricitabine/tenofovir disoproxil fumarate tablets
- p24 antigen production in cervico-vaginal tissues infected with HIV [ Time Frame: Day 14 ]• Assess p24 antigen production in cervicovaginal tissues infected ex vivo with HIV-1BaL at baseline and after using Truvada tablets or tenofovir intravaginal ring
- Analysis of integrated DNA [ Time Frame: Day 14 ]Integrated viral DNA in cervicovaginal tissues infected ex vivo with HIV-1BaL at baseline and after using Truvada tablets or tenofovir intravaginal ring
- Anti-HIV activity in cervicovaginal fluid (CVF) [ Time Frame: Day 14 ]Anti-HIV activity in cervicovaginal fluid at baseline and after using Truvada tablets and tenofovir intravaginal ring
- Cervicovaginal tissue, fluid and plasma concentrations of tenofovir [ Time Frame: Day 14 ]Concentrations after use of Truvada tablets and tenofovir intravaginal ring
- Cervicovaginal tissue concentration of tenofovir diphosphate [ Time Frame: Day 14 ]Concentrations after use of Truvada tablets and tenofovir intravaginal ring.
- Cervicovaginal tissue, fluid and plasma concentrations of emtricitabine [ Time Frame: Day 14 ]Concentrations after use of Truvada tablets and tenofovir intravaginal ring.
- Cervicovaginal tissue concentration of emtricitabine triphosphate [ Time Frame: Day 14 ]Concentrations after use of Truvada tablets and tenofovir intravaginal ring.
- Endogenous nucleotide concentrations in cervicovaginal tissue [ Time Frame: Day 14 ]Endogenous nucleotides; dATP and dCTP concentrations in cervicovaginal tissue after use of Truvada tablets and tenofovir intravaginal ring
- Adherence markers in used IVRs [ Time Frame: Day 14 ]Adherence biomarkers from used IVRs returned to clinic after two weeks of use
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722343
|United States, Virginia|
|Eastern Virginia Medical School|
|Norfolk, Virginia, United States, 23507|
|Principal Investigator:||Andrea R Thurman, M.D.||Eastern Virginia Medical School|