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

Stopped early

Conditions studied: HIV

In brief

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.

Key facts

Study ID

NCT02641444

Run by

University of North Carolina, Chapel Hill

People needed

5

Starts

2016-04-13

Expected to finish

2017-08-29

Last updated by the study team

2018-01-17

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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)

You may not qualify if…

• 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.
• 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.

Where it is running

• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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