HIV InfectionsPhase 1NCT03393468
Pharmacokinetic Study of Dapivirine Gel Administered Rectally to HIV-1 Seronegative Adults
A Phase 1 study testing Dapivirine gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the pharmacokinetics of dapivirine gel administered rectally to HIV-1 seronegative adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dapivirine gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2018to 3 Dec 2018
- 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
- Men and transgender women who are 18 years or older at Screening, verified per site standard operating procedure (SOP)
- Able and willing to provide written informed consent
- HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II of the study protocol and willing to receive HIV test results
- Able and willing to provide adequate locator information, as defined in site SOP
- Available to return for all study visits and willing to comply with study participation requirements
- In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee
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- At Screening, history of consensual receptive anal intercourse (RAI) at least once in the past year per participant report
- Willing not to take part in other research studies involving drugs, medical devices, genital or rectal products, or vaccines for the duration of study participation (including the time between Screening and Enrollment)
- Willing to abstain from RAI, receptive oral anal stimulation (i.e., rimming), rectal stimulation via fingers, as well as the insertion of any non-study products into the rectum for 72 hours before and after each study visit
Who cannot join
- At Screening:
- Hemoglobin Grade 1 or higher*
- Platelet count Grade 1 or higher*
- White blood count Grade 2 or higher*
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher*
- Serum creatinine greater than 1.3 times the site laboratory upper limit of normal (ULN)
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- International normalized ratio (INR) greater than 1.5 times the site laboratory ULN
- Positive for hepatitis C antibody
- Positive for hepatitis B surface antigen
- History of inflammatory bowel disease by participant report
- (*As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1, July 2017)
- Note: Otherwise eligible participants with an exclusionary test result (other than HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV)) can be re-tested during the screening process. If a participant is re-tested and a non-exclusionary result is documented within 30 days of providing informed consent for screening, the participant may be enrolled.
- Known adverse reaction to latex or polyurethane (ever)
- Anticipated use of and/or unwillingness to abstain from the following medications during study participation:
- Anticoagulant medications
- Aspirin (greater than 81 mg/day)
- Non-steroidal anti-inflammatory drugs (NSAIDS)
- Any other drugs that are associated with increased likelihood of bleeding
- Rectally-administered medications or products containing nonoxynol-9 (N-9) or corticosteroids
- CYP3A inducer(s) and/or inhibitor(s) as specified in the MTN-033 Study Specific Procedures (SSP) Manual
- Hormone-replacement therapy in tablet, patch, injectable or gel form
- Known adverse reaction to any of the components of the study product, applicator or coital simulation device
- Use of pre-exposure prophylaxis (PrEP) for HIV prevention within 1 month prior to Enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation
- Use of post-exposure prophylaxis (PEP) for potential HIV exposure within the 6 months prior to Enrollment
- Use of systemic immunomodulatory medications within the 6 months prior to Enrollment, and/or anticipated use during trial participation
- RAI without a condom and/or penile-vaginal intercourse with a partner who is known to be HIV-positive in the 6 months prior to Enrollment
- Non-therapeutic injection drug use in the 12 months prior to Enrollment
- Participation in research studies involving drugs, medical devices, genital or rectal products, or vaccines within 30 days of the Enrollment Visit
- Per participant report at Screening, treatment of an anogenital sexually transmitted infection (STI) (after diagnosis) within the past 3 months
- At Screening, participant-reported symptoms, and/or clinical or laboratory diagnosis of active anorectal or reproductive tract infection (RTI) requiring treatment per current CDC guidelines (http://www.cdc.gov/std/treatment) or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic Neisseria gonorrhea (GC), Chlamydia trachomatis (CT) infection, syphilis, active herpes simplex virus (HSV) lesions, anogenital sores or ulcers, or symptomatic genital warts, chancroid, trichomoniasis.
- Note: Otherwise eligible participants with an exclusionary UTI may be re-tested during the screening process.
- At Enrollment, active anorectal infection or RTI requiring treatment per current CDC guidelines (http://www.cdc.gov/std/treatment) or symptomatic UTI. Infections requiring treatment include symptomatic GC, CT, syphilis, active HSV lesions, anogenital sores or ulcers, symptomatic genital warts, trichomoniasis, chancroid.
- Note: HSV-1 or HSV-2 seropositive diagnosis with no active lesions is permitted since treatment is not required.
- Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213
About this study
Official title: An Open Label Randomized Phase 1 Pharmacokinetic Study of Dapivirine Gel Administered Rectally to HIV-1 Seronegative Adults
The purpose of this study is to evaluate the pharmacokinetics of dapivirine gel administered rectally to HIV-1 seronegative adults.
Read the detailed description
This study will evaluate the pharmacokinetics (PK) of dapivirine gel administered rectally to HIV-1 seronegative adults.
Participants will be randomly assigned to two groups: Sequence A or Sequence B. Participants in Sequence A will receive 2.5 g of dapivirine gel administered rectally via an applicator, followed by a 2- to 4-week washout period. Participants will then receive a second dose of up to 10 g of dapivirine gel administered rectally via a coital simulation device. Participants in Sequence B will receive up to 10 g of dapivirine gel administered rectally via a coital simulation device, followed by a 2- to 4-week washout period. Participants will then receive a second dose of 2.5 g of dapivirine gel administered rectally via an applicator.
Participants will be in the study for approximately 1 month and will attend 7 study visits. Study visits may include behavioral assessments, physical examinations, blood and urine collection, throat and anorectal sample collection, and PK sampling.
- Conditions
- HIV Infections
- Being tested
- Dapivirine gel
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapivirine gelDrug
Dapivirine gel (0.05%); administered rectally
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Dapivirine gel | Experimental | Participants will receive 2.5 g of dapivirine gel administered rectally via an applicator, followed by a 2- to 4-week washout period. Participants will then receive a second dose of up to 10 g of dapivirine gel administered rectally via a coital simulation device. Receives: Drug: Dapivirine gel |
| Sequence B: Dapivirine gel | Experimental | Participants will receive up to 10 g of dapivirine gel administered rectally via a coital simulation device, followed by a 2- to 4-week washout period. Participants will then receive a second dose of 2.5 g of dapivirine gel administered rectally via an applicator. Receives: Drug: Dapivirine gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of dapivirine concentrations in rectal fluid
As assessed by pharmacokinetic sampling and analysis
Measured: Measured through approximately 1 month
Measurement of dapivirine concentrations in plasma
As assessed by pharmacokinetic sampling and analysis
Measured: Measured through approximately 1 month
Measurement of dapivirine concentrations in rectal mucosal tissue homogenates
As assessed by pharmacokinetic sampling and analysis
Measured: Measured through approximately 1 month
Secondary outcomes (1)
Frequency of Grade 2 or higher adverse events (AEs)
As defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 2 and 3 (Male Genital [Dated November 2007] and Rectal [Clarification Dated May 2012] Grading Tables for Use in Microbicide Studies)
Measured: Measured through approximately 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start10 May 2018
- Primary completion3 Dec 2018
- Study completion3 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ken Ho, MD, Study chair, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393468
- Sponsor's protocol ID
- MTN-033
- Other IDs
- 12065
- Status last verified
- Oct 2019
- First submitted
- 2 Jan 2018
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Randomized Phase 1 Pharmacokinetic Study of Dapivirine Gel Administered Rectally to HIV-1 Seronegative Adults
- ClinicalTrials.gov ID
- NCT03393468
- Acronym / sponsor ID
- MTN-033
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 10 May 2018 (actual)
- Primary completion
- 3 Dec 2018 (actual)
- Study completion
- 3 Dec 2018 (actual)
- First posted
- 8 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the pharmacokinetics of dapivirine gel administered rectally to HIV-1 seronegative adults.
Detailed description
This study will evaluate the pharmacokinetics (PK) of dapivirine gel administered rectally to HIV-1 seronegative adults.
Participants will be randomly assigned to two groups: Sequence A or Sequence B. Participants in Sequence A will receive 2.5 g of dapivirine gel administered rectally via an applicator, followed by a 2- to 4-week washout period. Participants will then receive a second dose of up to 10 g of dapivirine gel administered rectally via a coital simulation device. Participants in Sequence B will receive up to 10 g of dapivirine gel administered rectally via a coital simulation device, followed by a 2- to 4-week washout period. Participants will then receive a second dose of 2.5 g of dapivirine gel administered rectally via an applicator.
Participants will be in the study for approximately 1 month and will attend 7 study visits. Study visits may include behavioral assessments, physical examinations, blood and urine collection, throat and anorectal sample collection, and PK sampling.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Dapivirine gel | Experimental | Drug: Dapivirine gelParticipants will receive 2.5 g of dapivirine gel administered rectally via an applicator, followed by a 2- to 4-week washout period. Participants will then receive a second dose of up to 10 g of dapivirine gel administered rectally via a coital simulation device. |
| Sequence B: Dapivirine gel | Experimental | Drug: Dapivirine gelParticipants will receive up to 10 g of dapivirine gel administered rectally via a coital simulation device, followed by a 2- to 4-week washout period. Participants will then receive a second dose of 2.5 g of dapivirine gel administered rectally via an applicator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and transgender women who are 18 years or older at Screening, verified per site standard operating procedure (SOP)
- Able and willing to provide written informed consent
- HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II of the study protocol and willing to receive HIV test results
- Able and willing to provide adequate locator information, as defined in site SOP
- Available to return for all study visits and willing to comply with study participation requirements
Key exclusion criteria (34 listed)
- At Screening:
- Known adverse reaction to latex or polyurethane (ever)
- Anticipated use of and/or unwillingness to abstain from the following medications during study participation:
- Known adverse reaction to any of the components of the study product, applicator or coital simulation device
- Use of pre-exposure prophylaxis (PrEP) for HIV prevention within 1 month prior to Enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapivirine gelDapivirine gel (0.05%); administered rectally | Drug | Sequence A: Dapivirine gel, Sequence B: Dapivirine gel |
Primary outcome
Measurement of dapivirine concentrations in rectal fluid
Time frame: Measured through approximately 1 month
As assessed by pharmacokinetic sampling and analysis
Measurement of dapivirine concentrations in plasma
Time frame: Measured through approximately 1 month
As assessed by pharmacokinetic sampling and analysis
Measurement of dapivirine concentrations in rectal mucosal tissue homogenates
Time frame: Measured through approximately 1 month
As assessed by pharmacokinetic sampling and analysis
1 secondary outcome
Frequency of Grade 2 or higher adverse events (AEs)
Time frame: Measured through approximately 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken Ho, MD study chair
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dapivirine gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 9 inclusion and 34 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 25 Oct 2021. 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?
Measurement of dapivirine concentrations in rectal fluid (time frame: Measured through approximately 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2021.