HIVNCT02641444

Antiretroviral Localization in Gut-Associated Lymphoid Tissue and Lower Female Genital Tract Tissue of HIV+ Subjects

An observational study of HIV, run by University of North Carolina, Chapel Hill at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: HIV
What is being tested?: Blood plasma collection, Cervical and Vaginal Biopsy and Colonoscopy with Ileal and Rectal Biopsy
Type of treatment: Surgery or procedure
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 13 Apr 2016to 29 Aug 2017
Phase: Observational
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 65 years
Women only
No healthy volunteers
Adult, Older adult

Study population: This study will consist of 22 HIV positive women between 18-65 years of age (inclusive) with an intact gastrointestinal tract, uterus and cervix who are available to complete all study procedures at UNC.

Who may be able to join

Healthy HIV-positive female subjects between the ages of 18 and 65 years, inclusive on the date of screening, with an intact gastrointestinal tract, uterus, and cervix. Healthy is defined as no clinically relevant abnormalities that would interfere with the interpretation of results, or pose unnecessary risk onto volunteers due to study procedures.
All subjects must have an undetectable viral load at the time of screening or a documented undetectable viral load within the preceding 3 months of screening.
All subjects must be receiving one of the study regimens as part of their regular HIV care for at least 6 months preceding the date of enrollment.
Subjects must not have a history of GI disease (e.g. Crohn's disease, irritable bowel syndrome, ulcerative colitis, diverticulitis, colon cancer) or have a history of GI surgery.
All subjects (of childbearing potential) must have a negative serum pregnancy test at screening and negative urine pregnancy tests on days of sampling and should be using at least one of the following methods of contraception from the screening visit through 72 hours prior to inpatient admission (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)

Show all 20Show fewer

IUD placed at least 1 month prior to study enrollment
Bilateral tubal ligation (Sterilization)
Vasectomized male partners
Condom + Spermicide
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 37 kg/m2; and a total body weight > 45 kg (99 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.
Not receiving any known CYP3A4 inducers (rifampin, carbamazepine, St. John's wort) or inhibitors (ketoconazole, non-DHP calcium channel blockers, macrolide antibiotics) other than those contained in their HIV regimen for at least 6 months prior to enrollment.
Subject must be willing to abstain from sexual intercourse, douching, and all intravaginal and intrarectal objects and products for at least 72 hours prior to enrollment until study completion.
Subject must be Hepatitis B surface antigen negative as documented on screening labs (or documented in their clinical record).
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 (i.e. bowel preparation regimen)

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 cervical resection that would preclude obtaining a cervical biopsy.
Subjects who are pregnant, possibly pregnant or lactating.
Subjects with a presence of abnormal vaginal discharge bleeding at screening.
History of febrile illness within five days prior to enrollment.
A positive urine drug screen for illicit substances (e.g. cocaine, methamphetamines) that would increase risk associated with sedation.

Show all 20Show fewer

Active Hepatitis B infection
An untreated-positive test for syphilis, gonorrhea, Chlamydia, or trichomonas at screening. Tests for these STIs will be performed on samples from both the vaginal and rectal orifices.
Any clinically significant laboratory chemistry or hematology result Grade 3 or greater according to the 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.
Participation in a clinical trial involving genital tract or rectal biopsies within 6 months preceding enrollment.
Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.
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 36 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 bowel preparation appropriately.
Unwilling or unable to comply with the dietary and concomitant drug restrictions in regard to study drug administration as outlined in the study procedures and prohibited medications sections.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

The purpose of this research study is to find out how the drugs Truvada® (tenofovir/emtricitabine), Isentress® (raltegravir), Reyataz® (atazanavir), Sustiva® (efavirenz), and Selzentry® (maraviroc) get into the intestines and the female genital tract. All of these drugs are very effective at reducing the number of HIV viruses in the blood, however it is unknown how the drugs move around inside tissues where HIV might be hiding. This study will determine specifically where in the tissue the drug and the HIV are located through the use of a new technology that takes creates a picture of the tissue. This information will help scientists determine the best way to make new drugs to target the hidden HIV in tissue.

Read the detailed description

Study Design

This is an observational study of TFV, FTC, RAL, ATZ, EFV, and MVC localization within GALT (terminal ileum \& rectum), vaginal, and cervical tissues in the setting of undetectable plasma HIV. Participants will be selected on the basis of receiving either TFV/FTC/RAL, TFV/FTC/ATZ/r, TFV/FTC/EFV, or TFV/FTC/MVC as part of their ongoing HIV care. After participant education, informed consent, and screening for study eligibility, participants will be evaluated at baseline. All samples will be collected over the course of a 36 hour inpatient visit as described below.

Study Sampling

Blood plasma will be collected after enrollment (approximately 2 hours after the start of the inpatient visit) and before the start of bowel preparation (approximately 2-12 hours after the start of the inpatient visit).
Vaginal and cervical tissue will be collected after enrollment (approximately 2 hours after the start of the inpatient visit) and before the start of bowel preparation (approximately 2-12 hours after the start of the inpatient visit).
Rectal and terminal ileal tissue will be collected at approximately 18 hours after the initiation of the bowel preparation.

Pharmacokinetic Analysis All blood, cervical, vaginal, ileal and rectal tissue samples will be analyzed by the Clinical Pharmacology and Analytical Chemistry Laboratory (CPAC) at the UNC School of Pharmacy, which is directed by the principal investigator, Angela Kashuba, PharmD. To visualize ARV localization within a tissue, one biopsy from each tissue site will be analyzed by IR-MALDESI using a previously established workflow for our laboratory.

HIV localization within tissues will be performed using in situ hybridization (ISH) in collaboration with the Haase lab at the University of Minnesota. This group has substantial experience in HIV RNA detection from human tissues, and preliminary studies have confirmed our ability to detect HIV RNA from serial slices of tissues.

Localization within tissue slices will be evaluated by IR-MALDESI. Measurement of the distribution of each ARV within pre-specified anatomical sub-regions across a tissue slice will allow for identification of areas where drug is either concentrating or lacking. ISH and IHC analysis of serial tissue slices will allow us to co-localize ARVs with HIV and HIV target cells. Once these anatomical areas have been visually identified, imaging software will be used to isolate and quantify the signal.

Conditions: HIV
Being tested: Blood plasma collection, Cervical and Vaginal Biopsy, Colonoscopy with Ileal and Rectal Biopsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Blood plasma collectionProcedure or surgery
Approximately 3mL of blood will be taken from each subject just prior to the colonoscopy.
Cervical and Vaginal BiopsyProcedure or surgery
2 biopsies each will be collected from the vaginal wall and the cervix
Colonoscopy with Ileal and Rectal BiopsyProcedure or surgery
10 biopsies each will be collected from the rectum and terminal ileum from each subject during the colonoscopy.

Study groups in NCT02641444
Study group	Role	What they receive
Efavirenz		Receiving efavirenz as part of their HIV regimen. Will undergo blood plasma collection, cervical and vaginal biopsy, and colonoscopy with ileal and rectal biopsy. Receives: Procedure: Blood plasma collection; Procedure: Cervical and Vaginal Biopsy; Procedure: Colonoscopy with Ileal and Rectal Biopsy
Atazanavir		Receiving atazanavir as part of their HIV regimen. Will undergo blood plasma collection, cervical and vaginal biopsy, and colonoscopy with ileal and rectal biopsy. Receives: Procedure: Blood plasma collection; Procedure: Cervical and Vaginal Biopsy; Procedure: Colonoscopy with Ileal and Rectal Biopsy
Raltegravir		Receiving raltegravir as part of their HIV regimen. Will undergo blood plasma collection, cervical and vaginal biopsy, and colonoscopy with ileal and rectal biopsy. Receives: Procedure: Blood plasma collection; Procedure: Cervical and Vaginal Biopsy; Procedure: Colonoscopy with Ileal and Rectal Biopsy
Maraviroc		Receiving maraviroc as part of their HIV regimen. Will undergo blood plasma collection, cervical and vaginal biopsy, and colonoscopy with ileal and rectal biopsy. Receives: Procedure: Blood plasma collection; Procedure: Cervical and Vaginal Biopsy; Procedure: Colonoscopy with Ileal and Rectal Biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

Antiretroviral tissue localization
Tissues collected during inpatient stay will be frozen for later analysis (i.e. MSI-derived images of TFV, FTC, RAL, ATZ, EFV, and MVC localization within tissue slices.) to be completed within 6 months of tissue collection.
Measured: Samples collected within 24 hours post-dose

Secondary outcomes (4)

Quantitation of antiretroviral tissue concentrations by LC-MS/MS
Tissues collected during inpatient stay will be frozen for later analysis (i.e. TFV, FTC, RAL, ATZ , EFV, and MVC concentrations in tissues as determined by LC-MS/MS) to be completed within 6 months of tissue collection.
Measured: Samples collected within 24 hours post-dose
Immunohistochemical images of CD3, CD4, and CD8 distribution within tissue slices
Tissues collected during inpatient stay will be frozen for later analysis (i.e. IHC staining for localization of HIV target cells within serial slices of tissue) to be completed within 6 months of tissue collection.
Measured: Samples collected within 24 hours post-dose
in-situ hybridization images of HIV RNA distribution within tissue slices
Tissues collected during inpatient stay will be frozen for later analysis (i.e. ISH staining for localization of HIV RNA within serial slices of tissue) to be completed within 6 months of tissue collection.
Measured: Samples collected within 24 hours post-dose
Quantification of antiretroviral tissue concentrations by MSI
Tissues collected during inpatient stay will be frozen for later analysis (i.e. TFV, FTC, RAL, ATZ , EFV, and MVC concentrations in tissues as determined by MSI) to be completed within 6 months of tissue collection.
Measured: Samples collected within 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Apr 201629 Aug 2017

First posted29 Dec 2015 (estimated)
Study start13 Apr 2016
Primary completion29 Aug 2017
Study completion29 Aug 2017

Why it stopped: Study team finished their analysis.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIVStudies 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: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02641444
Sponsor's protocol ID: 15-2865
Status last verified: Apr 2017
First submitted: 17 Dec 2015
Last updated: 17 Jan 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Thompson CG, Bokhart MT, Sykes C, Adamson L, Fedoriw Y, Luciw PA, Muddiman DC, Kashuba AD, Rosen EP. Mass spectrometry imaging reveals heterogeneous efavirenz distribution within putative HIV reservoirs. Antimicrob Agents Chemother. 2015 May;59(5):2944-8. doi: 10.1128/AAC.04952-14. Epub 2015 Mar 2.
PubMed 25733502
Robichaud G, Garrard KP, Barry JA, Muddiman DC. MSiReader: an open-source interface to view and analyze high resolving power MS imaging files on Matlab platform. J Am Soc Mass Spectrom. 2013 May;24(5):718-21. doi: 10.1007/s13361-013-0607-z. Epub 2013 Mar 28.
PubMed 23536269

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Antiretroviral Localization in Gut-Associated Lymphoid Tissue and Lower Female Genital Tract Tissue of HIV+ Subjects
ClinicalTrials.gov ID: NCT02641444
Acronym / sponsor ID: 15-2865
Conditions: HIV
Study type: Observational
Recruitment status: TerminatedReason stopped: Study team finished their analysis.
Enrolment: 5 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Study start: 13 Apr 2016 (actual)
Primary completion: 29 Aug 2017 (actual)
Study completion: 29 Aug 2017 (actual)
First posted: 29 Dec 2015 (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.

Detailed description

Study Design

Study Sampling

Blood plasma will be collected after enrollment (approximately 2 hours after the start of the inpatient visit) and before the start of bowel preparation (approximately 2-12 hours after the start of the inpatient visit).
Vaginal and cervical tissue will be collected after enrollment (approximately 2 hours after the start of the inpatient visit) and before the start of bowel preparation (approximately 2-12 hours after the start of the inpatient visit).
Rectal and terminal ileal tissue will be collected at approximately 18 hours after the initiation of the bowel preparation.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 4

Arm	Type	Receives
Efavirenz	–	Procedure: Blood plasma collection, Procedure: Cervical and Vaginal Biopsy, Procedure: Colonoscopy with Ileal and Rectal BiopsyReceiving efavirenz as part of their HIV regimen. Will undergo blood plasma collection, cervical and vaginal biopsy, and colonoscopy with ileal and rectal biopsy.
Atazanavir	–	Procedure: Blood plasma collection, Procedure: Cervical and Vaginal Biopsy, Procedure: Colonoscopy with Ileal and Rectal BiopsyReceiving atazanavir as part of their HIV regimen. Will undergo blood plasma collection, cervical and vaginal biopsy, and colonoscopy with ileal and rectal biopsy.
Raltegravir	–	Procedure: Blood plasma collection, Procedure: Cervical and Vaginal Biopsy, Procedure: Colonoscopy with Ileal and Rectal BiopsyReceiving raltegravir as part of their HIV regimen. Will undergo blood plasma collection, cervical and vaginal biopsy, and colonoscopy with ileal and rectal biopsy.
Maraviroc	–	Procedure: Blood plasma collection, Procedure: Cervical and Vaginal Biopsy, Procedure: Colonoscopy with Ileal and Rectal BiopsyReceiving maraviroc as part of their HIV regimen. Will undergo blood plasma collection, cervical and vaginal biopsy, and colonoscopy with ileal and rectal biopsy.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: This study will consist of 22 HIV positive women between 18-65 years of age (inclusive) with an intact gastrointestinal tract, uterus and cervix who are available to complete all study procedures at UNC.

Key inclusion criteria (20 listed)

Healthy HIV-positive female subjects between the ages of 18 and 65 years, inclusive on the date of screening, with an intact gastrointestinal tract, uterus, and cervix. Healthy is defined as no clinically relevant abnormalities that would interfere with the interpretation of results, or pose unnecessary risk onto volunteers due to study procedures.
All subjects must have an undetectable viral load at the time of screening or a documented undetectable viral load within the preceding 3 months of screening.
All subjects must be receiving one of the study regimens as part of their regular HIV care for at least 6 months preceding the date of enrollment.
Subjects must not have a history of GI disease (e.g. Crohn's disease, irritable bowel syndrome, ulcerative colitis, diverticulitis, colon cancer) or have a history of GI surgery.
All subjects (of childbearing potential) must have a negative serum pregnancy test at screening and negative urine pregnancy tests on days of sampling and should be using at least one of the following methods of contraception from the screening visit through 72 hours prior to inpatient admission (at which time the women will be asked to remain abstinent until after their follow-up visit):

Key exclusion criteria (20 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 cervical resection that would preclude obtaining a cervical biopsy.
Subjects who are pregnant, possibly pregnant or lactating.
Subjects with a presence of abnormal vaginal discharge bleeding at screening.
History of febrile illness within five days prior to enrollment.

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
Blood plasma collectionApproximately 3mL of blood will be taken from each subject just prior to the colonoscopy.	Procedure or surgery	Atazanavir, Efavirenz, Maraviroc, Raltegravir
Cervical and Vaginal Biopsy2 biopsies each will be collected from the vaginal wall and the cervix	Procedure or surgery	Atazanavir, Efavirenz, Maraviroc, Raltegravir
Colonoscopy with Ileal and Rectal Biopsy10 biopsies each will be collected from the rectum and terminal ileum from each subject during the colonoscopy.	Procedure or surgery	Atazanavir, Efavirenz, Maraviroc, Raltegravir

Primary outcome

Antiretroviral tissue localization
Time frame: Samples collected within 24 hours post-dose
Tissues collected during inpatient stay will be frozen for later analysis (i.e. MSI-derived images of TFV, FTC, RAL, ATZ, EFV, and MVC localization within tissue slices.) to be completed within 6 months of tissue collection.

4 secondary outcomes

Quantitation of antiretroviral tissue concentrations by LC-MS/MS
Time frame: Samples collected within 24 hours post-dose
Immunohistochemical images of CD3, CD4, and CD8 distribution within tissue slices
Time frame: Samples collected within 24 hours post-dose
in-situ hybridization images of HIV RNA distribution within tissue slices
Time frame: Samples collected within 24 hours post-dose
Quantification of antiretroviral tissue concentrations by MSI
Time frame: Samples collected within 24 hours post-dose

Results and safety

The study was stopped early (reason given: Study team finished their analysis.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
Background: PubMed 25733502Thompson CG, Bokhart MT, Sykes C, Adamson L, Fedoriw Y, Luciw PA, Muddiman DC, Kashuba AD, Rosen EP. Mass spectrometry imaging reveals heterogeneous efavirenz distribution within putative HIV reservoirs. Antimicrob Agents Chemother. 2015 May;59(5):2944-8. doi: 10.1128/AAC.04952-14. Epub 2015 Mar 2.
Background: PubMed 23536269Robichaud G, Garrard KP, Barry JA, Muddiman DC. MSiReader: an open-source interface to view and analyze high resolving power MS imaging files on Matlab platform. J Am Soc Mass Spectrom. 2013 May;24(5):718-21. doi: 10.1007/s13361-013-0607-z. Epub 2013 Mar 28.
Individual participant dataSharing planned: No

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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

University of North Carolina, Chapel Hill

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of HIV, 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 20 inclusion and 20 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: stopped early, as of the sponsor's last update on 17 Jan 2018. 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.

Are results available for this study?

The study was stopped early (reason given: Study team finished their analysis.). Results are not available in the source record.

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?

Antiretroviral tissue localization (time frame: Samples collected within 24 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02641444, which also lists 2 linked publications.

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 17 Jan 2018.