A Feasibility Study to Assess Tenofovir and Maraviroc Protection Against HIV-1 in Cervical and Vaginal Explants
This study is currently recruiting participants.
Verified February 2014 by University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Angela Kashuba, PharmD, University of North Carolina, Chapel Hill
First received: January 15, 2014
Last updated: February 11, 2014
Last verified: February 2014
The purpose of this study is to determine the feasibility of a novel method to assess antiretroviral efficacy for protection against HIV-1 infection in vaginal and cervical tissue biopsies.
Healthy Adult Females
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||A Feasibility Study to Assess Protection of Vaginal and Cervical Tissues From Ex-Vivo HIV-1 Challenge Following Oral Administration of Maraviroc and Tenofovir
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||June 2014 (Final data collection date for primary outcome measure)
Experimental: All Participants
Maraviroc 600 mg + Tenofovir 600 mg
- Tenofovir disoproxil fumurate
Other Name: Selzentry
Participants: Six premenopausal healthy volunteer women between 18-49 years of age with an intact uterus and cervix.
Procedures (methods): Subjects will be given a single dose of two oral antiretrovirals (maraviroc 600mg/tenofovir 600 mg). Subjects will be monitored and assessed for adverse events post-dose. Subjects will be sent home and asked to return in 24 hours. 24 hours post-dose, two vaginal and two cervical biopsies will be obtained. These biopsies will then be placed in an ex-vivo culture system and exposed to HIV. Viral RNA will be measured over two days to determine whether the tissues were protected from infection. A final visit for safety will be conducted 7-14 days post-enrollment.
|Ages Eligible for Study:
||18 Years to 49 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including documented drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Subjects with a history of hysterectomy, or other clinically significant surgery of the female genital tract.
- Subjects who are pregnant, possibly pregnant or lactating
- Subjects with a presence of vaginal discharge or genital bleeding at screening
- History of febrile illness within five days prior to medication dosing.
- Any condition possibly affecting drug absorption (eg, gastrectomy).
- A positive urine drug screen.
- A positive result for HIV.
- Active Hepatitis B infection as determined by positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) tests (in the absence of HBsAb).
- Active Hepatitis C (HCV) infection as defined by positive HCV Ab (determined by multi-antigen EIA) and detectable Hepatitis C RNA.
- A positive test for syphilis, gonorrhea, Chlamydia, or trichomonas at screening.
- Any laboratory chemistry or hematology result Grade 2 or greater according to the Division of Allergy and Infectious Disease (DAIDS) Laboratory Grading Tables
- Treatment with an investigational drug within 4 months preceding the first dose of trial medication.
- History of regular alcohol consumption exceeding 14 drinks (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of spirits) per week.
- Use of prescription or nonprescription drugs, vitamins, and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of trial medication and unable to avoid use during the inpatient pharmacokinetic visit. As an exception, systemic hormonal methods of contraception can be continued.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Allergy to lidocaine or Monsel's solution.
- Allergy to latex.
- Abnormal pap smear in the past 12 months
- Any degree of ectopy or abnormality evident during the pelvic exam at screening.
- Any condition which, in the opinion of the investigator, is likely to interfere with follow-up or ability to take the study medication appropriately.
- Unwilling or unable to comply with the following dietary and concomitant drug restrictions in regard to study drug administration as outlined in the study procedures and prohibited medications sections.
- Subjects will not be allowed to eat or drink grapefruit containing products from 7 days prior to the first dose of trial medication until after collection of biopsy sample.
- Must refrain from taking any prescription, non-prescription, herbal, vitamin or dietary supplement within at least 7 days of the study visit through completion of the study without discussing with the study staff.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02039323
|CTRC University of North Carolina at Chapel Hill
|Chapel Hill, North Carolina, United States, 27599 |
|Contact: Melanie Nicol, PharmD 919-843-0321 firstname.lastname@example.org |
|Contact: Heather Prince, PA email@example.com |
|Principal Investigator: Angela Kashuba, PharmD |
University of North Carolina, Chapel Hill
No publications provided
||Angela Kashuba, PharmD, PharmD, University of North Carolina, Chapel Hill
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 15, 2014
||February 11, 2014
||United States: Food and Drug Administration
United States: Institutional Review Board
Keywords provided by University of North Carolina, Chapel Hill:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 14, 2014
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action