NCT02346084

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 8, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

January 20, 2015

Last Update Submit

September 5, 2017

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

  • AEs Grade 2 or higher as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events

    Female participants will be on study for approximately 12 to 16 weeks. Male participants will be on study for approximately 9 to 12 weeks. The total duration of the study will be approximately 9 months.

Study Arms (2)

Female Participants - Arms 1A through 9A

EXPERIMENTAL

Female Participants 9 Arms (1A through 9A) 3 Product Sequences Product Sequence 1 Rx1- MVC tablet PO Rx2- MVC 1% gel PR Rx3- MVC 1% gel PV Product Sequence 2 Rx1- MVC 1% gel PR Rx2- MVC 1% gel PV Rx3- MVC tablet PO Product Sequence 3 Rx1- MVC 1% gel PV Rx2- MVC tablet PO Rx3- MVC 1% gel PR 3 Biopsy Schedules D8- (\~2-hr after the 8th dose) D9- (\~24-hr after the 8th dose) D10- (\~48-hr after the 8th dose)

Drug: Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)

Male Participants - Arms 1B through 4B

EXPERIMENTAL

Male Participants 4 Arms (1B through 4B) 2 Product Sequences 2 biopsy schedules Product Sequence 1 Rx1- MVC tablet PO Rx2- MVC 1% gel PR Product Sequence 2 Rx1- MVC 1% gel PR Rx2- MVC tablet PO Biopsy Schedule D8- (\~2-hr after the 8th dose) D10- (\~48-hr after the 8th dose)

Drug: Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)

Interventions

Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)DRUG

Tablets: daily 300 mg oral maraviroc, Selzentry®,(MVC) for 8 consecutive days Gel: daily rectally administered 1% MVC gel for 8 daily consecutive days Female Participants - will receive an additional third regimen of daily vaginally administered MVC 1% gel for 8 consecutive days. Each treatment regimen will be followed by a washout period of 14 to 21 days. Participants will also be randomized to a biopsy sampling schedule (i.e., D8, D9, or D10 sampling).

Also known as: Tablet - Selzentry®, (MVC)
Female Participants - Arms 1A through 9AMale Participants - Arms 1B through 4B

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • +8 more criteria

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:
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Magee Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • McGowan IM, Chawki S, Hendrix CW, Anton PA, Marzinke MA, Brand RM, Engstrom JC, Rohan LC, Abebe KZ, Richardson-Harman N, Siegel A, Reinhart A, Steytler J, Stall R, Spiegel H, Chen B, Achilles SL, Jacobson CE, Khanukova E, Cranston RD. A Randomized, Open-Label, Crossover Phase 1 Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel (the CHARM-03 Study). AIDS Res Hum Retroviruses. 2022 Apr;38(4):269-278. doi: 10.1089/AID.2021.0096. Epub 2021 Sep 14.

    PMID: 34384282DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

MaravirocTabletsGels

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical PreparationsColloidsComplex Mixtures

Study Officials

  • Ian McGowan, MD, PhD, FRCP

    Magee-Women's Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2015

First Posted

January 26, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

September 8, 2017

Record last verified: 2017-09

Locations

US(1)