HIV InfectionsPhase 1NCT01548560
Assessing the Safety of Dapivirine Gel and Film Formulations
A Phase 1 study testing Dapivirine Vaginal Film and Dapivirine Vaginal Gel in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 1 site in United States.
Trial summary
This is a study to determine the safety of dapivirine gel and dapvirine film for healthy, HIV-uninfected women aged 18-45 years using the product for 7 daily doses. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dapivirine Vaginal Film and Dapivirine Vaginal Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Feb 2014
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 through 45 years (inclusive) at screening
- Able and willing to provide written informed consent to be screened for and to take part in the study.
- Able and willing to provide adequate locator information
- HIV-uninfected based on testing performed by study staff at screening (per algorithm in Appendices I)
- 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 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 (approximately 35 days after enrollment)
- In general good health as determined by the site clinician
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- For participants older than 21, a pap result in the 12 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 non-Grade 0 Pap result per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines or per local standard of care, in the 12 calendar months prior to the Enrollment
- Note: For participants aged 18-21, a Grade-0 or adequately evaluated abnormal Pap smear is not required as the American Society for Colposcopy and Cervical Pathology recommends initiating screening at age 21.
- Agree to be sexually abstinent from Visit 1 until the completion of Visit 3
- Agree to use study condoms between Visits 3 and 4 (if heterosexually active)
- Agree to abstain from any other intravaginal product or penetration (including sex toys, excluding tampons) until Visit 3
- Willingness to undergo all study-related assessments and follow all study-related procedures
- At screening and enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products while enrolled in this trial
Who cannot join
- Menopause (as defined as amenorrhea for one year or more without an alternative etiology)
- Hysterectomy
- Participant report of any of the following:
- Known adverse reaction to any of the study products (ever)
- Known adverse reaction to latex (ever)
- Non- therapeutic injection drug use in the 12 months prior to Screening
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- Surgical procedure involving the pelvis in the 90 days prior to enrollment (includes dilation and curettage or evacuation, and cryosurgery; does not include cervical biopsy for evaluation of an abnormal pap smear)
- Participation in a drug, spermicide and/or microbicide study in the 30 days prior to enrollment or anticipated participation in an investigational drug study in the next 8 weeks
- Pregnancy within 90 days of enrollment
- Currently lactating
- Use of a diaphragm, NuvaRing®, or spermicide for contraception
- Internal vaginal use of any device or product (except tampons) in the 7 days prior to enrollment
- Urogenital infection or suspected infection within 14 days of enrollment including: symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis; or cervical infection, including N. gonorrhea, C. trachomatis, or mucopurulent cervicitis; syphilis; HSV lesions, or other sores (Note: seropositive HSV without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection; recent exposure to a partner with GC, CT, Trichomonas, syphilis, or NGU
- Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment
- As determined by the PI, has any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease
- Menses or other vaginal bleeding at the time of the Enrollment visit
- Has any of the following laboratory abnormalities per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 December 2004:
- Grade 1 or higher AST or ALT
- Grade 1 or higher creatinine
- Grade 2 or higher hemoglobin
- Grade 1 or higher platelets (Note: otherwise eligible participants with an exclusionary test may be re-tested during the screening process).
- Any condition that, in the opinion of the Investigator, would preclude provision of consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
This is a study to determine the safety of dapivirine gel and dapvirine film for healthy, HIV-uninfected women aged 18-45 years using the product for 7 daily doses.
- Conditions
- HIV Infections
- Being tested
- Dapivirine Vaginal Film, Dapivirine Vaginal Gel
- Keywords
- HIV Infections, Anti-HIV agents, HIV-1
- 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 Vaginal FilmDrug
Dosage form: vaginal film Dosage: 1.25mg Frequency: 7 daily doses
Dapivirine Vaginal GelDrug
Dosage form: vaginal gel Dosage: 0.5%, 2.5g Frequency: 7 daily doses
| Study group | Role | What they receive |
|---|---|---|
| Dapivirine Vaginal Gel | Experimental | Dosage form: vaginal gel Dosage: 0.5%, 2.5g Frequency: 7 daily doses Receives: Drug: Dapivirine Vaginal Film; Drug: Dapivirine Vaginal Gel |
| Placebo Gel | Placebo comparator | Dosage form: vaginal gel Dosage: N/A Frequency: 7 daily doses Receives: Drug: Dapivirine Vaginal Gel |
| Dapvirine Vaginal Film | Experimental | Dosage form: vaginal film Dosage: 1.25mg Frequency: 7 daily doses Receives: Drug: Dapivirine Vaginal Film; Drug: Dapivirine Vaginal Gel |
| Vaginal Film | Placebo comparator | Dosage form: vaginal film Dosage: N/A Frequency: 7 daily doses Receives: Drug: Dapivirine Vaginal Film |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Grade 2 or higher Adverse Events
The safety/toxicity endpoint is clinical or laboratory evidence of a Grade 2 or higher Adverse Event as defined by the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 and the Female Genital Grading Table for Use in Microbicide Studies which is judged to be related to study product.
Measured: 5-11 weeks
Secondary outcomes (2)
Changes in vaginal flora and vaginal pH
Measured: 5-11 weeks
Systemic and local absorption levels of dapivirine
Measured: 5-11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2014
- Study completionFeb 2014
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.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katherine Bunge, MD MPH, Study chair, Magee Womens Hospital, UPitt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01548560
- Sponsor's protocol ID
- FAME 02
- Status last verified
- Sep 2017
- First submitted
- 1 Mar 2012
- Last updated
- 8 Sep 2017
- Results posted
- No
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
- Assessing the Safety of Dapivirine Gel and Film Formulations
- ClinicalTrials.gov ID
- NCT01548560
- Acronym / sponsor ID
- FAME 02
- Conditions
- HIV Infections
- Keywords
- HIV Infections, Anti-HIV agents, HIV-1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Mar 2012 (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.
This is a study to determine the safety of dapivirine gel and dapvirine film for healthy, HIV-uninfected women aged 18-45 years using the product for 7 daily doses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dapivirine Vaginal Gel | Experimental | Drug: Dapivirine Vaginal Film, Drug: Dapivirine Vaginal GelDosage form: vaginal gel Dosage: 0.5%, 2.5g Frequency: 7 daily doses |
| Placebo Gel | Placebo comparator | Drug: Dapivirine Vaginal GelDosage form: vaginal gel Dosage: N/A Frequency: 7 daily doses |
| Dapvirine Vaginal Film | Experimental | Drug: Dapivirine Vaginal Film, Drug: Dapivirine Vaginal GelDosage form: vaginal film Dosage: 1.25mg Frequency: 7 daily doses |
| Vaginal Film | Placebo comparator | Drug: Dapivirine Vaginal FilmDosage form: vaginal film Dosage: N/A Frequency: 7 daily doses |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age 18 through 45 years (inclusive) at screening
- Able and willing to provide written informed consent to be screened for and to take part in the study.
- Able and willing to provide adequate locator information
- HIV-uninfected based on testing performed by study staff at screening (per algorithm in Appendices I)
- 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 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 (approximately 35 days after enrollment)
Key exclusion criteria (22 listed)
- Menopause (as defined as amenorrhea for one year or more without an alternative etiology)
- Hysterectomy
- Participant report of any of the following:
- Urogenital infection or suspected infection within 14 days of enrollment including: symptomatic candidiasis, trichomonas vaginalis, and symptomatic bacterial vaginosis; or cervical infection, including N. gonorrhea, C. trachomatis, or mucopurulent cervicitis; syphilis; HSV lesions, or other sores (Note: seropositive HSV without active lesions will not be excluded); acute pelvic inflammatory disease; urinary tract infection; recent exposure to a partner with GC, CT, Trichomonas, syphilis, or NGU
- Antibiotic or antifungal therapy (vaginal or systemic) within 7 days of enrollment
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 Vaginal FilmDosage form: vaginal film Dosage: 1.25mg Frequency: 7 daily doses | Drug | Dapivirine Vaginal Gel, Dapvirine Vaginal Film, Vaginal Film |
| Dapivirine Vaginal GelDosage form: vaginal gel Dosage: 0.5%, 2.5g Frequency: 7 daily doses | Drug | Dapivirine Vaginal Gel, Dapvirine Vaginal Film, Placebo Gel |
Primary outcome
Number of Grade 2 or higher Adverse Events
Time frame: 5-11 weeks
The safety/toxicity endpoint is clinical or laboratory evidence of a Grade 2 or higher Adverse Event as defined by the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 and the Female Genital Grading Table for Use in Microbicide Studies which is judged to be related to study product.
2 secondary outcomes
Changes in vaginal flora and vaginal pH
Time frame: 5-11 weeks
Systemic and local absorption levels of dapivirine
Time frame: 5-11 weeks
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.
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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.
Katherine Bunge, MD MPH study chair
Magee Womens Hospital, UPitt
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 Vaginal Film and Dapivirine Vaginal Gel in people with HIV Infections, 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 13 inclusion and 22 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. 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?
Number of Grade 2 or higher Adverse Events (time frame: 5-11 weeks). 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 Sep 2017.