Healthy Adult FemalesPhase 1NCT02039323
A Feasibility Study to Assess Tenofovir and Maraviroc Protection Against HIV-1 in Cervical and Vaginal Explants
A Phase 1 study testing Tenofovir and Maraviroc in people with Healthy Adult Females, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Females
- What is being tested?
- Tenofovir and Maraviroc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy pre-menopausal female subjects between the ages of 18-49, inclusive, with an intact uterus and cervix. (Healthy is defined as no irregular menstrual cycles or clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
- All subjects must have an estimated calculated creatinine clearance (eCcr) of at least 80 mL/min by the Cockcroft-Gault formula where: eCcr (female) in mL/min = [(140 - age in years) x (weight in kg) x 0.85] / (72x serum creatinine in mg/dL).
- All subjects must have a negative serum pregnancy test at screening and negative urine pregnancy tests on days of dose administration and should be using at least one of the following methods of contraception from the screening visit through 72 hours prior to first outpatient visit (at which time the women will be asked to remain abstinent until after their follow-up visit)
- Systemic hormonal contraceptive (oral, depot, transdermal or implant)
- Intrauterine device placed at least 1 month prior to study enrollment
- Bilateral tubal ligation (Sterilization)
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- Vasectomized male partners
- Condom + Spermicide
- Unless engaged in sexual activity with female only sex partners or abstinent for at least 3 months prior with no intention of becoming sexually active during the study period. Any history of recent or present concomitant male sex partners will be addressed and ruled out in the context of screening participants for eligibility for the protocol
- Body Mass Index (BMI) of approximately 18 to 34 kg/m2; and a total body weight > 50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
- Subject must have documentation of a normal pap smear within 36 months of the screening visit, no procedures for abnormal cervical/vaginal pathology in the last six months, at least one prior gynecological visit as part of subject's routine medical history. If subjects have had a gynecological exam but no history of Pap smear, a Pap smear will be completed at screening and paid for by the study.
- Subject must be willing to abstain from sexual intercourse, douching, and all intravaginal objects and products for at least 72 hours prior to first study visit until study completion.
- Subject must be HIV-1 and Hepatitis B surface antigen negative as documented on screening labs.
- Subject must not be actively involved in the conception process.
- Subject must be able to swallow pills and have no allergies to any component of the study products.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
CTRC University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: A Feasibility Study to Assess Protection of Vaginal and Cervical Tissues From Ex-Vivo HIV-1 Challenge Following Oral Administration of Maraviroc and Tenofovir
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.
Read the detailed description
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.
- Conditions
- Healthy Adult Females
- Being tested
- Tenofovir, Maraviroc
- Keywords
- Tenofovir, Tenofovir disoproxil, Maraviroc, Pharmacologic Actions, Anti-HIV agents, Pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
Also called Tenofovir disoproxil fumurate, Viread
MaravirocDrug
Also called Selzentry
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | Maraviroc 600 mg + Tenofovir 600 mg Receives: Drug: Tenofovir; Drug: Maraviroc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of explant infection
To determine if oral administration of tenofovir plus maraviroc can protect mucosal tissues from HIV infection in an ex-vivo HIV challenge of biopsies collected post-dose.
Measured: 2 days post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult FemalesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angela Kashuba, PharmD, University of North Carolina, Chapel Hill
- Investigators
- Angela DM Kashuba, PharmD, Principal investigator, UNC at Chapel hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02039323
- Sponsor's protocol ID
- 13-3940
- Status last verified
- Jun 2014
- First submitted
- 15 Jan 2014
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Assess Protection of Vaginal and Cervical Tissues From Ex-Vivo HIV-1 Challenge Following Oral Administration of Maraviroc and Tenofovir
- ClinicalTrials.gov ID
- NCT02039323
- Acronym / sponsor ID
- 13-3940
- Conditions
- Healthy Adult Females
- Keywords
- Tenofovir, Tenofovir disoproxil, Maraviroc, Pharmacologic Actions, Anti-HIV agents, Pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Drug: Tenofovir, Drug: MaravirocMaraviroc 600 mg + Tenofovir 600 mg |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Healthy pre-menopausal female subjects between the ages of 18-49, inclusive, with an intact uterus and cervix. (Healthy is defined as no irregular menstrual cycles or clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
- All subjects must have an estimated calculated creatinine clearance (eCcr) of at least 80 mL/min by the Cockcroft-Gault formula where: eCcr (female) in mL/min = [(140 - age in years) x (weight in kg) x 0.85] / (72x serum creatinine in mg/dL).
- All subjects must have a negative serum pregnancy test at screening and negative urine pregnancy tests on days of dose administration and should be using at least one of the following methods of contraception from the screening visit through 72 hours prior to first outpatient visit (at which time the women will be asked to remain abstinent until after their follow-up visit)
- Body Mass Index (BMI) of approximately 18 to 34 kg/m2; and a total body weight > 50 kg (110 lbs).
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenofovirAlso: Tenofovir disoproxil fumurate, Viread | Drug | All Participants |
| MaravirocAlso: Selzentry | Drug | All Participants |
Primary outcome
Evidence of explant infection
Time frame: 2 days post-biopsy
To determine if oral administration of tenofovir plus maraviroc can protect mucosal tissues from HIV infection in an ex-vivo HIV challenge of biopsies collected post-dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela DM Kashuba, PharmD principal investigator
UNC at Chapel hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tenofovir and Maraviroc in people with Healthy Adult Females, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of explant infection (time frame: 2 days post-biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2014.