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HIV PreventionPhase 1NCT03082690

ImQuest (IQP) DuoGel Phase 1 Pharmacokinetic Study

A Phase 1 study testing DuoGel in people with HIV Prevention, run by Johns Hopkins University 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 this study is describe the safety and single-dose pharmacokinetics of rectally-administered IQP (ImQuest Pharmaceuticals)-0528 (DuoGel) in plasma, rectal tissue biopsies, vaginal tissue biopsies, rectal fluid and cervicovaginal fluid as well as to assess the luminal distribution of IQP-0528 in the… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Prevention
What is being tested?
DuoGel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Nov 2017to 2 Jun 2019
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 18 years or older at screening
  • HIV-1 negative as documented at screening
  • Willing to use condoms for the duration of the study
  • Willing to refrain from aspirin and non-steroidal anti-inflammatory drug (NSAID) use for one week before and after each study biopsy visit
  • Available to return for all study visits
  • Agrees to sexually transmitted infection (STI) reporting requirements
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  • Able and willing to communicate in English
  • Able and willing to provide written informed consent
  • Able and willing to provide adequate information for locator purposes
  • Agrees not to participate in other research studies
  • Willing to refrain from receptive anal intercourse and insertion of anything in the rectum for 72 hours before and after rectal biopsies.
  • Additional inclusion criteria for women:
  • Be pre-menopausal
  • Have regular menstrual cycles (unless on contraception that causes amenorrhea or irregular menses)
  • Have a negative qualitative urine pregnancy test
  • Per participant report, using an effective method of contraception at enrollment; hormonal method (except vaginal ring) used continuously for the past 30 days; intrauterine device (IUD [copper or hormonal] inserted at least 30 days prior to enrollment); female sterilization; abstinent from sexual activity with male partner for the past 30 days; or sexual activity with vasectomized partner; and willingness to use effective method of contraception until the completion of final scheduled study visit if enrolled.
  • Willing to refrain from insertion of anything into the vagina for at least 72 hours before and 7 days after vaginal biopsies.

Who cannot join

  • Current known HIV-infected partners
  • Current use of anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin [>81 mg], NSAIDs, or Pradaxa®)
  • Current use of cytochrome P450 3A (CYP3A) inducer(s) and/or inhibitor(s)
  • Use of systemic immunomodulatory medications within 4 weeks of enrollment
  • Known allergic reaction to components of the study product
  • History of recurrent urticaria
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  • Participants whose whole body radiation exposure exceeds 5000 millirem (mRem)/year.
  • Participants who are currently receiving or have been on oral PrEP or PEP in the past month
  • Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study requirements.
  • Significant colorectal symptom(s) as determined by medical history or by participant self-report
  • Active rectal infection, requiring treatment per current Centers for Disease Control (CDC) guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active herpes simplex virus (HSV) lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts.
  • History of STI within the last 3 months.
  • Use of post-exposure (PEP) or pre-exposure (PrEP) prophylaxis within the last 6 months
  • History of significant gastrointestinal bleeding
  • Use of any rectally administered medications within 4 weeks of enrollment or unwillingness to refrain from use of any rectally administered medications 72 hours prior to any study dosing or biopsy visit
  • Use of any rectally administered products containing nonoxynol-9 (including condoms) or investigational products within 4 weeks of enrollment
  • Additional exclusion criteria for women:
  • Significant vaginal symptoms, genital lesions, erythema, edema or any other abnormal physical finding that, in the opinion of the investigator or designee, would contraindicate study participation.
  • Active female genital tract infection, requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active HSV lesions, chancroid, bacterial vaginosis, vaginal candidiasis, trichomonas, genital sores or ulcers, and, if clinically indicated, genital warts.
  • History of significant vaginal bleeding
  • Undiagnosed irregular uterine bleeding
  • Post-menopausal defined as 12 months of amenorrhea
  • Per participant report, abnormalities of the female genital tract, which, in the judgment of the investigator, might increase the risk of the study to the research participant.
  • Per participant report, history of cervical procedures (conization, Loop El electrosurgical Excision procedure (LEEP) procedure, cryosurgery) within the previous 6 months.
  • Per participant report, use of any vaginally administered medications within 4 weeks of enrollment
  • Per participant report, use of any vaginally administered products containing nonoxynol-9 (including condoms) or investigational products within 4 weeks of enrollment
  • Women who are pregnant or breastfeeding
  • Spermicide use within the last 30 days

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: Phase 1 Study of the Safety, Toxicity, Pharmacokinetics, Pharmacodynamics and Luminal Distribution of Single-dose DuoGel Through Rectal Administration

The purpose of this study is describe the safety and single-dose pharmacokinetics of rectally-administered IQP (ImQuest Pharmaceuticals)-0528 (DuoGel) in plasma, rectal tissue biopsies, vaginal tissue biopsies, rectal fluid and cervicovaginal fluid as well as to assess the luminal distribution of IQP-0528 in the rectum. Sixteen healthy volunteers will receive a single rectal dose of DuoGel, followed by blood, tissue and fluid sampling over the following 72 hours.

Read the detailed description

This is a phase 1 open label study of the safety, PK, and PD of single-dose 10 mL IQP-0528 through rectal administration. Pharmacokinetics (PK) will be assessed in multiple compartments: plasma, rectal tissue, vaginal tissue, rectal fluid and cervicovaginal fluid. The luminal distribution of DuoGel in the rectum will be evaluated with Single Photon Emission Computed Tomography/ X-ray Computed Tomography (SPECT/CT). Pharmacodynamics (PD) will be assessed in an ex vivo HIV explant challenge of rectal and vaginal tissue biopsies.

After completing the screening evaluation (Visit 1) and establishing participant eligibility, 16 eligible participants will be enrolled: 8 men and 8 women. A subsequent baseline visit (Visit 2) safety assessment and tissue ex vivo HIV explant challenge will be performed as baseline for comparison with later post-drug evaluation. Participants will receive a single 10 mL rectal dose of 99mTechnetium (99mTc) -radiolabelled DuoGel (Visit 3), followed by safety assessments and PK and PD sampling over three days (Visits 3, 4, and 5). Finally, a follow-up safety phone call is performed a week after all PK sampling and biopsies are collected.

Conditions
HIV Prevention
Being tested
DuoGel

What participants receive

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

  • DuoGelDrug

    Also called IQP-0528

    1% IQP-0528 in gel formulation

Study groups in NCT03082690
Study groupRoleWhat they receive
DuoGelExperimentalIQP-0528 1% gel administered rectally one time
Receives: Drug: DuoGel

What is being measured

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

  1. To assess systemic and local safety of 10 mL of IQP-0528 following rectal administration by adverse events.

    Grade 2 or above adverse events as measured by the Division of AIDS Toxicity Table

    Measured: One week

  2. To assess rectal PK of 10 mL of IQP-0528

    Maximum Concentration (Cmax)

    Measured: 72 hours

  3. To assess rectal PK of 10 mL of IQP-0528

    Time to Maximum Concentration (Tmax)

    Measured: 72 hours

  4. To assess rectal PK of 10 mL of IQP-0528

    Area Under the Curve (AUC)

    Measured: 72 hours

  5. To assess rectal PK of 10 mL of IQP-0528

    Terminal elimination half-life

    Measured: 72 hours

Secondary outcomes (4)

  1. To compare rectal PK between men and women

    Maximum Concentration (Cmax)

    Measured: 72 hours

  2. To compare rectal PK between men and women

    Time to Maximum Concentration (Tmax)

    Measured: 72 hours

  3. To compare rectal PK between men and women

    Area Under the Curve (AUC)

    Measured: 72 hours

  4. To compare rectal PK between men and women

    Terminal elimination half-life

    Measured: 72 hours

Timeline

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

  1. First posted17 Mar 2017
  2. Study start1 Nov 2017
  3. Primary completion30 May 2019
  4. Study completion2 Jun 2019

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03082690
Sponsor's protocol ID
IRB00041089
Other IDs
5U19AI101961
Status last verified
Oct 2019
First submitted
5 Mar 2017
Last updated
14 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Al-Khouja A, Shieh E, Fuchs EJ, Marzinke MA, Bakshi RP, Hummert P, Ham AS, Buckheit KW, Breakey J, Weld ED, Chen H, Caffo BS, Buckheit RW, Hendrix CW. Examining the Safety, Pharmacokinetics, and Pharmacodynamics of a Rectally Administered IQP-0528 Gel for HIV Pre-Exposure Prophylaxis: A First-In-Human Study. AIDS Res Hum Retroviruses. 2021 Jun;37(6):444-452. doi: 10.1089/AID.2020.0188. Epub 2021 Jan 25.

    PubMed 33371779

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DuoGel in people with HIV Prevention, run by Johns Hopkins University 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 17 inclusion and 28 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 14 Oct 2019. 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?

To assess systemic and local safety of 10 mL of IQP-0528 following rectal administration by adverse events. (time frame: One week). The study lists 5 primary outcomes in all. 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 NCT03082690, 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 14 Oct 2019.

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