Topical Penile ExposuresPhase 1NCT01277640
Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures
A Phase 1 study testing dapivirine in people with Topical Penile Exposures, run by International Partnership for Microbicides, Inc. at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety of male genitalia when exposed to dapivirine gel following seven once daily applications. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Topical Penile Exposures
- What is being tested?
- dapivirine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Jul 2011
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age at Screening, verified per site standard operating procedure (SOP)
- Able and willing to provide written informed consent to be screened for and take part in the study
- At Screening, able and willing to provide adequate locator information, as defined per site SOP
- Able and willing to communicate in written and spoken English
- HIV-uninfected at Screening per Algorithm in Appendix II
- In general good health, according to the clinical judgment of the Investigator of Record (IoR) or designee
Show all 10Show fewer
- Willing to abstain from vaginal, oral and anal intercourse (including receptive anal intercourse), even with a condom; masturbation, and other activities that may cause irritation or injury to the penis during study participation
- Willing to abstain from using any genitally-applied preparations (except use of usual cleansing products for genital hygiene) other than the study product during study participation
- Willing to abstain from non-urgent surgical procedures of the penis/GU area for the duration of study participation (e.g. circumcision)
- At Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, or genital products for the duration of study participation (until all follow-up visits are completed)
Who cannot join
- Participant report of any of the following:
- Known adverse reaction to any of the study products or components of the study products (ever)
- Post-exposure prophylaxis (PEP) for HIV exposure within 6 months prior to Enrollment
- Penile procedures (e.g. biopsy, circumcision) within 42 days or less prior to Enrollment
- Participation in any other research study involving drugs, medical devices, or genital products within 30 days or less prior to Enrollment
- Within the three months prior to Enrollment, history of a non-gonococcal urethritis and/or sexually transmitted infection (STI), including outbreak of genital herpes or condylomata
Show all 23Show fewer
- For uncircumcised men, the treatment of candidal balanoposthitis/ balanitis within 30 days prior to Enrollment
- History of recurrent dermatosis (e.g. eczema)
- Non-therapeutic injection drug use in the 12 months prior to Screening
- Currently using an immunosuppressant (with the exception of local nongenital use of low potency products e.g. inhaled corticosteroid for asthma)
- Has any of the following laboratory abnormalities at Screening:
- Hemoglobin < 10.0 g/dL
- Platelet count < 100,000/mm3
- White blood cell count < 2,000 cells/mm3
- Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 2.5x the site laboratory upper limit of normal (ULN)
- Serum creatinine > 1.3x the site laboratory ULN
- Calculated creatinine clearance less than 80 mL/min by the Cockcroft-Gault formula where creatinine clearance in mL/min = (140-age in years) x (weight in kg) x 0.85/72 x serum creatinine in mg/dL Note: Otherwise eligible participants with any of the above exclusionary laboratory results may be re-tested. 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.
- At Screening or Enrollment, diagnosed with STI or reproductive tract infection (RTI) requiring treatment, per current Centers for Disease Control and Prevention (CDC) guidelines
- At Screening or Enrollment, has a clinically apparent Grade 1 or higher genital exam finding (observed by study staff)
- At Screening or Enrollment, has Grade 1 or higher genital or urinary symptoms
- At Screening or Enrollment, diagnosed with phimosis or hypospadias
- At Screening or Enrollment, penile, scrotal piercing or penile tattoos observed during genital examination
- 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 the study objectives
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
The purpose of this study is to determine the safety of male genitalia when exposed to dapivirine gel following seven once daily applications.
- Conditions
- Topical Penile Exposures
- Being tested
- dapivirine, matched placebo, universal placebo
- Keywords
- male tolerance, HIV-1, microbicide, dapivirine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapivirineDrug
- dosage form: gel 0.05%
- dosage: 2.5g
- frequency: once daily
- duration: 7 days
matched placeboDrug
- dosage form: gel, no api
- dosage: 2.5g
- frequency: once daily
- duration: 7 days
universal placeboDrug
- dosage form: gel, HEC-based
- dosage: 2.5g
- frequency: once daily
- duration: 7 days
| Study group | Role | What they receive |
|---|---|---|
| matched placebo | Placebo comparator | Not described Receives: Drug: matched placebo |
| universal placebo | Placebo comparator | Not described Receives: Drug: universal placebo |
| dapivirine | Active comparator | Not described Receives: Drug: dapivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the genitourinary safety of dapivirine gel (0.05%), the endpoint was the proportion of men subjected to dapivirine gel or placebo gel experiencing specific, protocol-defined safety events during the study (see description).
Any evidence of Grade 2 or higher male genitourinary adverse event(s) as defined by the DAIDS AE Grading Table Version 1.0, December 2004 (Clarification dated August 2009), Addendum 2 (Male Genital Toxicity Table for Use in Topical Microbicide Studies)
Measured: 8 days
Secondary outcomes (3)
To assess the pharmacokinetics in plasma following 7 days of once daily penile application of dapivirine gel (0.05%)
Dapivirine concentrations in blood
Measured: 8 days
To assess the systemic safety following 7 days of once daily penile application of dapivirine gel (0.05%)
Grade 2 and higher clinical and laboratory adverse events as defined by the DAIDS AE Grading Table Version 1.0, December 2004 (Clarification dated August 2009) and the Male Genital Toxicity Table for Use in Topical Microbicide Studies
Measured: 8 days
To assess the acceptability following 7 days of once daily penile application of dapivirine gel (0.05%)
Proportion of participants who at their Final Clinic Visit report via the acceptability questionnaire, that they would be very likely to use the candidate microbicide during sexual intercourse in the future
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startMar 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Topical Penile ExposuresStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ross D. Cranston, MD, FRCP, Study chair, Division of Infectious Diseases, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277640
- Sponsor's protocol ID
- MTN-012/IPM 010
- Status last verified
- Sep 2017
- First submitted
- 13 Jan 2011
- Last updated
- 8 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cranston RD, Hoesley C, Carballo-Dieguez A, Hendrix CW, Husnik M, Levy L, Hall W, Soto-Torres L, Nel AM. A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010). AIDS Res Hum Retroviruses. 2014 Feb;30(2):184-9. doi: 10.1089/AID.2013.0170. Epub 2013 Oct 26.
PubMed 24070431
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures
- ClinicalTrials.gov ID
- NCT01277640
- Acronym / sponsor ID
- MTN-012/IPM 010
- Conditions
- Topical Penile Exposures
- Keywords
- male tolerance, HIV-1, microbicide, dapivirine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 17 Jan 2011 (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.
The purpose of this study is to determine the safety of male genitalia when exposed to dapivirine gel following seven once daily applications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| matched placebo | Placebo comparator | Drug: matched placebo |
| universal placebo | Placebo comparator | Drug: universal placebo |
| dapivirine | Active comparator | Drug: dapivirine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years of age at Screening, verified per site standard operating procedure (SOP)
- Able and willing to provide written informed consent to be screened for and take part in the study
- At Screening, able and willing to provide adequate locator information, as defined per site SOP
- Able and willing to communicate in written and spoken English
- HIV-uninfected at Screening per Algorithm in Appendix II
Key exclusion criteria (23 listed)
- Participant report of any of the following:
- At Screening or Enrollment, diagnosed with STI or reproductive tract infection (RTI) requiring treatment, per current Centers for Disease Control and Prevention (CDC) guidelines
- At Screening or Enrollment, has a clinically apparent Grade 1 or higher genital exam finding (observed by study staff)
- At Screening or Enrollment, has Grade 1 or higher genital or urinary symptoms
- At Screening or Enrollment, diagnosed with phimosis or hypospadias
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* dosage form: gel 0.05% * dosage: 2.5g * frequency: once daily * duration: 7 days | Drug | dapivirine |
| matched placebo* dosage form: gel, no api * dosage: 2.5g * frequency: once daily * duration: 7 days | Drug | matched placebo |
| universal placebo* dosage form: gel, HEC-based * dosage: 2.5g * frequency: once daily * duration: 7 days | Drug | universal placebo |
Primary outcome
To determine the genitourinary safety of dapivirine gel (0.05%), the endpoint was the proportion of men subjected to dapivirine gel or placebo gel experiencing specific, protocol-defined safety events during the study (see description).
Time frame: 8 days
Any evidence of Grade 2 or higher male genitourinary adverse event(s) as defined by the DAIDS AE Grading Table Version 1.0, December 2004 (Clarification dated August 2009), Addendum 2 (Male Genital Toxicity Table for Use in Topical Microbicide Studies)
3 secondary outcomes
To assess the pharmacokinetics in plasma following 7 days of once daily penile application of dapivirine gel (0.05%)
Time frame: 8 days
To assess the systemic safety following 7 days of once daily penile application of dapivirine gel (0.05%)
Time frame: 8 days
To assess the acceptability following 7 days of once daily penile application of dapivirine gel (0.05%)
Time frame: 8 days
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 8 Sep 2017.
- Results publication: PubMed 24070431Cranston RD, Hoesley C, Carballo-Dieguez A, Hendrix CW, Husnik M, Levy L, Hall W, Soto-Torres L, Nel AM. A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010). AIDS Res Hum Retroviruses. 2014 Feb;30(2):184-9. doi: 10.1089/AID.2013.0170. Epub 2013 Oct 26.
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.
Ross D. Cranston, MD, FRCP study chair
Division of Infectious Diseases, University of Pittsburgh Medical Center
2 sites 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 in people with Topical Penile Exposures, run by International Partnership for Microbicides, Inc. at 2 sites 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 10 inclusion and 23 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 2 sites 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 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 determine the genitourinary safety of dapivirine gel (0.05%), the endpoint was the proportion of men subjected to dapivirine gel or placebo gel experiencing specific, protocol-defined safety events during the study (see description). (time frame: 8 days). 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 NCT01277640, 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.