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HIV/AIDSPhase 1NCT02346084

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

A Phase 1 study testing Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV) in people with HIV/AIDS, run by International Partnership for Microbicides, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
HIV/AIDS
What is being tested?
Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
Jan 2015to Mar 2016
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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:
  • 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

Who cannot join

  • 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
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  • 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).
  • Body mass index (BMI) < 18 or > 35 kg/m2
  • At screening: participant-reported symptoms, and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic bacterial vaginosis, symptomatic vaginal candidiasis, other vaginitis, trichomoniasis, Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, pelvic inflammatory disease, genital sores or ulcers, cervicitis, or symptomatic genital warts requiring treatment. Note that an HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required. Note: In cases of genital GC/CT identified at screening, one re-screening 2 months after screening visit will be allowed
  • Has any of the following laboratory abnormalities at Screening:
  • CHARM-03, Version 1.0 28 31st July 2014
  • Hemoglobin < 10.0 g/dL
  • Platelet count less than 100,000/mm3
  • White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3
  • Calculated creatinine clearance ≤ 70 mL/minute using the Cockcroft-Gault equation
  • Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5× the site laboratory ULN
  • Total bilirubin > 2.5 ULN
  • ≥ +1 glucose or +2 protein on urinalysis (UA)
  • International Normalized Ratio (INR) test > 1.5× the site laboratory upper limit of normal (ULN)
  • Positive for Hepatitis B surface antigen (HBsAg)
  • Positive for Hepatitis C antibody (HCV Ab)
  • CCR5 Δ 32 homozygous or heterozygous
  • Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease In addition to the criteria listed above, female participants will be excluded if they meet any of the following criteria:
  • Participant reports any of the following at Screening:
  • Last pregnancy outcome or gynecological surgery 90 days or less prior to screening
  • Intends to become pregnant during the period of study participation
  • Chronic and/or recurrent symptomatic vaginal candidiasis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Magee Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: CHARM-03: A Randomized, Open Label, Crossover Phase 1 Safety and Pharmacokinetic Study of Oral Maraviroc and Maraviroc 1% Gel Administered Rectally and Vaginally to HIV-1 Seronegative Adults

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.

Read the detailed description

Trail 11991 is a Phase 1 randomized, open label, single-site trial. Approximately 19 participants (9 female, 10 male) will be randomized to the 9 female study arms and 4 male study arms with 1-3 participants per arm. The randomization will be completed for the product sequence and the timing of tissue sample collection.

All participants will receive both study products by multiple routes of administration (i.e., PO, PR, [and PV for female participants]), and they will be randomized to the order of product sequence and specimen sampling schedule. The male participants will receive oral and rectal MVC and the female participants will receive oral, rectal, and vaginal MVC, in randomized sequence.

Participant accrual will take approximately 6 months. Male participants will be on study for approximately 9 to 12 weeks. Female participants will be on study for approximately 12 to 16 weeks. The total duration of the study will be approximately 9 months.

Conditions
HIV/AIDS
Being tested
Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

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

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

    Also called Tablet - Selzentry®, (MVC)

    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).

Study groups in NCT02346084
Study groupRoleWhat they receive
Female Participants - Arms 1A through 9AExperimentalFemale 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)
Receives: Drug: Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)
Male Participants - Arms 1B through 4BExperimentalMale 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)
Receives: Drug: Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)

What is being measured

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

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

    Measured: 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.

Timeline

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

  1. First posted26 Jan 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2015
  4. Study completionMar 2016

Resources

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02346084
Sponsor's protocol ID
Maraviroc 1% Gel (Charm)
Other IDs
AI082637
Status last verified
Sep 2017
First submitted
20 Jan 2015
Last updated
8 Sep 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 34384282

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV) in people with HIV/AIDS, run by International Partnership for Microbicides, Inc. 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 23 inclusion and 45 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 8 Sep 2017. 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?

AEs Grade 2 or higher as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (time frame: 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.). 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 NCT02346084, which also lists 1 linked publication.

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 8 Sep 2017.

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