HIV 1 InfectionPhase 1NCT03044379
Dapivirine Gel Rectal Safety and PK Study
A Phase 1 study testing Dapivirine gel (0.05%) in people with HIV 1 Infection, run by International Partnership for Microbicides, Inc. at 1 site in United States.
Trial summary
Dapivirine Gel Rectal Safety and PK Study Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV 1 Infection
- What is being tested?
- Dapivirine gel (0.05%)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2015to Nov 2017
- 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 - 45 years (inclusive), verified per site SOP
- Able and willing to provide written informed consent
- HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II 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 IoR or designee
- Per participant report, a history of consensual RAI at least once in the past calendar year
- Willing to not take part in other research studies involving drugs, medical devices, genital products, or vaccines for the duration of study participation, including the time between Screening and Enrollment
Who cannot join
- Hemoglobin Grade 1 or higher*
- Platelet count Grade 1 or higher*
- White blood count Grade 2 or higher*
- Serum creatinine 1.3 the site laboratory upper limit of normal (ULN)
- International normalized ratio (INR) 1.5 the site laboratory ULN
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher*
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- Positive for hepatitis C antibody
- Positive for hepatitis B surface antigen
- History of inflammatory bowel disease by participant report
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
Dapivirine Gel Rectal Safety and PK Study
Read the detailed description
A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
- Conditions
- HIV 1 Infection
- Being tested
- Dapivirine gel (0.05%), Universal HEC placebo gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapivirine gel (0.05%)Drug
MTN-026/IPM 038 will use the HTI pre-filled applicator, the same applicator that has been utilized in other rectal studies.
Universal HEC placebo gelOther
| Study group | Role | What they receive |
|---|---|---|
| Dapivirine Gel | Active comparator | Participants will be randomized to receive a single dose of dapivirine gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic. Receives: Drug: Dapivirine gel (0.05%) |
| Placebo Gel HEC | Placebo comparator | Participants will be randomized to receive the universal HEC placebo gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic. Receives: Other: Universal HEC placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application.
To evaluate the safety of dapivirine gel formulation when applied rectally.
Measured: 9-12 months
Secondary outcomes (1)
Acceptability
To identify product attributes considered likely to challenge and facilitate future sustained use of rectally applied dapivirine gel.
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study start29 Sep 2015
- Primary completionSep 2017 (estimated)
- Study completionNov 2017 (estimated)
Why it stopped: Current program is on hold, not for safety reason
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 1 InfectionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03044379
- Sponsor's protocol ID
- MTN-026/ IPM 038
- Status last verified
- Oct 2016
- First submitted
- 6 Sep 2016
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
- ClinicalTrials.gov ID
- NCT03044379
- Acronym / sponsor ID
- MTN-026/ IPM 038
- Conditions
- HIV 1 Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Current program is on hold, not for safety reason
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Sep 2015 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- 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.
Dapivirine Gel Rectal Safety and PK Study
Detailed description
A Randomized, Double Blind, Placebo-Controlled Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapivirine Gel | Active comparator | Drug: Dapivirine gel (0.05%)Participants will be randomized to receive a single dose of dapivirine gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic. |
| Placebo Gel HEC | Placebo comparator | Other: Universal HEC placebo gelParticipants will be randomized to receive the universal HEC placebo gel rectally, followed by 7 daily doses of the same product to be administered under direct observation in the clinic. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age of 18 - 45 years (inclusive), verified per site SOP
- Able and willing to provide written informed consent
- HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II 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 (9 listed)
- Hemoglobin Grade 1 or higher*
- Platelet count Grade 1 or higher*
- White blood count Grade 2 or higher*
- Serum creatinine 1.3 the site laboratory upper limit of normal (ULN)
- International normalized ratio (INR) 1.5 the site laboratory ULN
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 gel (0.05%)MTN-026/IPM 038 will use the HTI pre-filled applicator, the same applicator that has been utilized in other rectal studies. | Drug | Dapivirine Gel |
| Universal HEC placebo gel | Other | Placebo Gel HEC |
Primary outcome
Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application.
Time frame: 9-12 months
To evaluate the safety of dapivirine gel formulation when applied rectally.
1 secondary outcome
Acceptability
Time frame: 9-12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (0.05%) in people with HIV 1 Infection, 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 8 inclusion and 9 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: withdrawn, as of the sponsor's last update on 8 Feb 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety To characterize the systemic and compartmental pharmacokinetics of dapivirine gel following rectal application. (time frame: 9-12 months). 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 8 Feb 2017.