Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel in HIV-1 Seronegative Adults

Completed · Phase 1

Conditions studied: HIV/AIDS

In brief

The purpose of the study is to evaluate the safety, acceptability, and PK/PD profile of maraviroc gel following rectal and vaginal administration. The study also includes oral exposure to maraviroc.

Key facts

Study ID

NCT02346084

Run by

International Partnership for Microbicides, Inc.

People needed

19

Starts

2015-01-01

Expected to finish

2016-03-01

Last updated by the study team

2017-09-08

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age of 18 through 45 at screening, verified per site SOP
• Male participants, born male; female participants, born female.
• Willing and able to communicate in English
• Willing and able to provide written informed consent to take part in the study
• Willing and able to provide adequate locator information, as defined in site SOP
• Availability to return for all study visits, barring unforeseen circumstances
• Understands and agrees to local sexually transmitted infection (STI) reporting requirements
• HIV-1 seronegative at screening and enrollment
• Must be in general good health in the opinion of the investigator
• Willing to abstain from insertion of anything in the rectum (e.g., penis, sex toy, medication, enemas) 72 hours before all rectal sampling visits and 72 after rectal biopsy visits
• Must agree to use study-provided condoms for insertive and receptive intercourse, whether vaginal or anal, for the duration of the study
• Must agree not to participate in other concurrent interventional and/or drug trials
• Female participants must meet the following criteria:
• Per participant report at Screening:
• Not pregnant or breastfeeding
• Regular menstrual cycles with at least 21 days between menses
• Satisfactory cervical Pap result in the 24 calendar months prior to Enrollment consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009), or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines in the 12 calendar months prior to Enrollment.
• Willing to abstain from vaginal insertion of anything (e.g., penis, sex toy, tampon, medication, douche) for 72 hours before all cervicovaginal sampling visits and 1 week after cervical biopsy visits
• Per participant report at Enrollment:
• e) Using an effective method of contraception and intending to continue use of an effective method for the duration of study participation. Effective methods include hormonal methods (except contraceptive vaginal rings), intrauterine device (IUD) inserted at least 28 days prior
• Male participants must meet the following criteria:
• Per participant report at Enrollment:
• Using an effective method of contraception and intending to continue use of an effective method for the duration of study participation. Effective methods include male condoms, surgical sterilization, being a man who identifies as a man who has sex with men exclusively, sexually abstinent for the past 90 days, and/or female partner use of hormonal contraception, intrauterine device [IUD], or surgical sterilization

You may not qualify if…

• Undergoing or completed gender reassignment
• Participant reports any of the following at Screening:
• Post-exposure prophylaxis for HIV exposure within 4 weeks prior to screening
• Reports history of unprotected insertive or receptive anal intercourse within 3 months prior to screening
• History of sexually transmitted disease in the last 3 months
• Known HIV-infected partners
• Non-therapeutic injection drug use in the 12 months prior to screening
• History of recurrent urticaria
• Allergy to soy, soybeans, peanuts, methylparaben, propylparaben, or sorbic acid
• Use of antiretroviral medications with activity against HIV within the 4 weeks prior to the Enrollment
• Use of systemic immunomodulatory medications within the 4 weeks prior to the Enrollment
• Use of vaginally or rectally administered medications or products (including condoms) containing Nonoxynol-9 (N-9) within the 4 weeks prior to the Enrollment
• Participating in another research study involving drugs or medical devices within the 4 weeks prior to the Enrollment
• Has plans to relocate away from the study site area during the period of study participation
• Per participant report at screening, anticipated use and/or unwillingness to abstain from the following medications during the period of study participation:
• Heparin, including Lovenox® (enoxaparin sodium)
• Warfarin
• Plavix® (clopidogrel bisulfate)
• Any other drugs that are associated with increased likelihood of bleeding following mucosal biopsy (e.g., daily high dose aspirin (> than 81 mg), NSAIDs, or Pradaxa®)
• Rectally or vaginally administered medications (including over-the-counter products)
• Use of potent CYP3A inhibitors (e.g., ketoconazole and clarithromycin), and CYP3A inducers (e.g., anti-convulsants and St.John's wort)
• Multiple dose dexamethasone
• Antiretroviral medications with activity against HIV
• History of significant gastrointestinal bleeding in the opinion of the investigator
• Abnormalities of the cervical, vaginal, or colorectal mucosa, or significant symptom(s), which in the opinion of the clinician represents a contraindication to protocol-required biopsies (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external hemorrhoids).

Where it is running

• Magee Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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