HIV InfectionsPhase 1NCT01363037
Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring
A Phase 1 study testing Dapivirine Vaginal Ring, Maraviroc Vaginal Ring and Dapivirine-Maraviroc Vaginal Ring in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by healthy women in the United States. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Dapivirine Vaginal Ring, Maraviroc Vaginal Ring and Dapivirine-Maraviroc Vaginal Ring
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2011to Aug 2012
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 through 40 years (inclusive) at screening, verified per site SOPs
- Able and willing to provide written informed consent to be screened for and take part in the study
- Able and willing to provide adequate locator information, as defined by the site SOPs
- HIV-uninfected, based on testing performed by study staff at Screening and Enrollment (per applicable algorithm in Appendix II)
- In general good health at Screening and Enrollment, as determined by the site IoR or designee
- At Screening, participant states willingness to abstain from receptive sexual activity (including oral, vaginal and anal intercourse) for the 14 days prior to enrollment and for the duration of study participation
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- Per participant report, using an effective method of contraception at Enrollment, and intending to continue use of an effective method for the duration of study participation. Effective methods include hormonal methods (except contraceptive vaginal rings), intrauterine device (IUD) inserted at least 28 days prior to enrollment, being a woman who identifies as a woman who has sex with women exclusively, sterilization, and/or sexually abstinent for the past 90 days
- Satisfactory 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 Grade 1 or higher Pap result per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines in the 12 calendar months prior to Enrollment.
- Per participant report at Screening and Enrollment, agrees not to participate in other research studies involving drugs, medical devices, or vaginal products for the duration of study participation
- Per participant report at Screening, regular menstrual cycles with at least 21 days between menses (does not apply to participants who report using a progestin-only method of contraception at screening, e.g., Depo-Provera or levonorgestrel-releasing IUD)
- At Screening and Enrollment, participant states a willingness to refrain from inserting any non-study vaginal products or objects into the vagina, including but not limited to, spermicides, female condoms, diaphragms, contraceptive vaginal rings, vaginal medications, menstrual cups, cervical caps (or any other vaginal barrier method), douches, lubricants, sex toys (vibrators, dildos, etc.), and tampons for the 5 days prior to enrollment throughout the duration of study participation. -- Note: At the Screening visit participant also agrees to refrain from the practices listed above for at least 5 days prior to enrollment.
Who cannot join
- Participant report of any of the following at Screening:
- Known adverse reaction to silicone, titanium dioxide, or to any of the components of the study products
- Use and/or anticipated use during the period of study participation of CYP3A inducer(s) and/or inhibitor(s)
- Chronic and/or recurrent candidiasis
- Non-therapeutic injection drug use in the 12 months prior to screening
- Post-exposure prophylaxis for HIV exposure within 6 months prior to screening
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- Last pregnancy outcome 90 days or less prior to screening
- Currently breastfeeding
- Hysterectomy
- Intends to become pregnant within the next 4 months
- Has plans to relocate away from the study site area in the next 4 months
- Reports participating in any other research study involving drugs, medical devices, or vaginal products 60 days or less prior to enrollment
- At Screening or Enrollment, as determined by the IoR/designee, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease, or at increased risk of cardiovascular events
- Has any of the following laboratory abnormalities at Screening:
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009)
- Calculated creatinine clearance less than 60 mL/min by the Cockcroft- Gault formula, where creatinine clearance (female) in mL/min = (140 - age in years) x (weight in kg) x (0.85)/72 x (creatinine in mg/dL)
- Hemoglobin Grade 1 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009)
- Platelet count Grade 1 or higher as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0, December, 2004 (Clarification dated August 2009) --- Note: Otherwise eligible participants with an exclusionary test result may be retested during the screening process. If a participant is re- tested and a nonexclusionary result is documented within 45 days of providing informed consent for screening, the participant may be enrolled.
- At Screening or Enrollment, is pregnant
- Diagnosed with urinary tract infection (UTI) at Screening or Enrollment
- -- Note: Otherwise eligible participants diagnosed with UTI during screening will be offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled.
- Diagnosed with pelvic inflammatory disease, a sexually transmitted infection (STI) or reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines (http://www.cdc.gov/std/treatment/) at Screening or Enrollment
- -- Note: Otherwise eligible participants diagnosed with STI or RTI during screening will be offered treatment and may be enrolled after completing treatment and all symptoms have resolved. If treatment is completed and symptoms have resolved within 45 days of obtaining informed consent for screening, the participant may be enrolled.
- At Screening or Enrollment, has a clinically apparent Grade 1 or higher pelvic exam finding (observed by study clinician or designee) per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009), Addendum 1, Female Genital Grading Table for Use in Microbicide Studies
- -- Note: Cervical friability bleeding associated with speculum insertion and/or specimen collection judged to be within the range of normal according to the clinical judgment of the IoR/designee is considered expected non-menstrual bleeding and is not exclusionary.
- At Screening, severe pelvic relaxation such that either the vaginal walls or the uterine cervix descend beyond the vaginal introitus with valsalva maneuver
- 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
3 sites in 1 country.
United States3 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
The Fenway Institute/Fenway Community Health
Boston, Massachusetts, 02115
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Phase 1 Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring
The purpose of this study is to assess the pharmacokinetics of the combination dapivirine and maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by healthy women in the United States.
- Conditions
- HIV Infections
- Being tested
- Dapivirine Vaginal Ring, Maraviroc Vaginal Ring, Placebo Vaginal Ring, Dapivirine-Maraviroc Vaginal Ring
- 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 RingDrug
dosage form: dapivirine vaginal ring dosage:25 mg frequency:continuous use duration:28 days
Maraviroc Vaginal RingDrug
dosage form: maraviroc vaginal ring dosage:100 mg frequency:continuous use duration:28 days
Placebo Vaginal RingOther
dosage form: placebo vaginal ring dosage:N/A frequency:continuous use duration:28 days
Dapivirine-Maraviroc Vaginal RingDrug
dosage form: combination vaginal ring dosage:25 mg dapivirine + 100 mg maraviroc frequency:continuous use duration:28 days
| Study group | Role | What they receive |
|---|---|---|
| Dapivirine-Maraviroc Vaginal Ring | Experimental | Not described Receives: Drug: Dapivirine-Maraviroc Vaginal Ring |
| Placebo Vaginal Ring | Placebo comparator | Not described Receives: Other: Placebo Vaginal Ring |
| Maraviroc Vaginal Ring | Active comparator | Not described Receives: Drug: Maraviroc Vaginal Ring |
| Dapivirine Vaginal Ring | Active comparator | Not described Receives: Drug: Dapivirine Vaginal Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: To assess and compare safety of VRs containing 25 mg dpv, or 100 mg mrv, or 25 mg dpv + 100 mg mrv, the endpoint was the proportion of women in the four arms experiencing specific, protocol defined safety events during the study (see description)
- Genitourinary events Grade 1 or higher as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009), Addendum 1, (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to study product
- Adverse events Grade 2 or higher as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009)
Measured: 7.5 weeks
Pharmacokinetics: Assessments of systemic and local concentrations of dapivirine and maraviroc in plasma, vaginal fluids and cervical tissue, respectively
Assessed during and after 28 days' of continuous use of a vaginal ring containing 25 mg dapivirine, or 100 mg maraviroc, or 25 mg dapivirine + 100 mg maraviroc.
Measured: 7.5 weeks
Secondary outcomes (2)
Evaluate the acceptability of the study VR in HIV-uninfected sexually abstinent women over 28 days of use
Participant report of acceptability including genitourinary and emotional (dis)comfort, awareness/feeling during daily activities, ring insertion/removal issues, and willingness to use in the future
Measured: 28 days
Evaluate the adherence to the study VR in HIV-uninfected sexually abstinent women over 28 days of use
Participant report of frequency of study VR removal/expulsions (voluntary and involuntary) and duration without VR inserted in vagina
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startNov 2011
- Primary completionAug 2012
- Study completionAug 2012
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 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beatrice A Chen, MD, MPH, Study chair, University of PittsburghLori Panther, MD, MPH, Study chair, The Fenway Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363037
- Sponsor's protocol ID
- MTN-013/IPM 026
- Status last verified
- Sep 2015
- First submitted
- 27 May 2011
- Last updated
- 10 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen BA, Panther L, Marzinke MA, Hendrix CW, Hoesley CJ, van der Straten A, Husnik MJ, Soto-Torres L, Nel A, Johnson S, Richardson-Harman N, Rabe LK, Dezzutti CS. Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics of Dapivirine and Maraviroc Vaginal Rings: A Double-Blind Randomized Trial. J Acquir Immune Defic Syndr. 2015 Nov 1;70(3):242-9. doi: 10.1097/QAI.0000000000000702.
PubMed 26034880
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring
- ClinicalTrials.gov ID
- NCT01363037
- Acronym / sponsor ID
- MTN-013/IPM 026
- Conditions
- HIV Infections
- Keywords
- HIV infections, Anti-HIV agents, HIV-1
- 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
- Nov 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Jun 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 assess the pharmacokinetics of the combination dapivirine and maraviroc vaginal ring and determine whether it is safe when used continuously for 28 days by healthy women in the United States.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dapivirine-Maraviroc Vaginal Ring | Experimental | Drug: Dapivirine-Maraviroc Vaginal Ring |
| Placebo Vaginal Ring | Placebo comparator | Other: Placebo Vaginal Ring |
| Maraviroc Vaginal Ring | Active comparator | Drug: Maraviroc Vaginal Ring |
| Dapivirine Vaginal Ring | Active comparator | Drug: Dapivirine Vaginal Ring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age 18 through 40 years (inclusive) at screening, verified per site SOPs
- Able and willing to provide written informed consent to be screened for and take part in the study
- Able and willing to provide adequate locator information, as defined by the site SOPs
- HIV-uninfected, based on testing performed by study staff at Screening and Enrollment (per applicable algorithm in Appendix II)
- In general good health at Screening and Enrollment, as determined by the site IoR or designee
Key exclusion criteria (27 listed)
- Participant report of any of the following at Screening:
- Reports participating in any other research study involving drugs, medical devices, or vaginal products 60 days or less prior to enrollment
- At Screening or Enrollment, as determined by the IoR/designee, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease, or at increased risk of cardiovascular events
- Has any of the following laboratory abnormalities at Screening:
- At Screening or Enrollment, is pregnant
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 Ringdosage form: dapivirine vaginal ring dosage:25 mg frequency:continuous use duration:28 days | Drug | Dapivirine Vaginal Ring |
| Maraviroc Vaginal Ringdosage form: maraviroc vaginal ring dosage:100 mg frequency:continuous use duration:28 days | Drug | Maraviroc Vaginal Ring |
| Placebo Vaginal Ringdosage form: placebo vaginal ring dosage:N/A frequency:continuous use duration:28 days | Other | Placebo Vaginal Ring |
| Dapivirine-Maraviroc Vaginal Ringdosage form: combination vaginal ring dosage:25 mg dapivirine + 100 mg maraviroc frequency:continuous use duration:28 days | Drug | Dapivirine-Maraviroc Vaginal Ring |
Primary outcome
Safety: To assess and compare safety of VRs containing 25 mg dpv, or 100 mg mrv, or 25 mg dpv + 100 mg mrv, the endpoint was the proportion of women in the four arms experiencing specific, protocol defined safety events during the study (see description)
Time frame: 7.5 weeks
* Genitourinary events Grade 1 or higher as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009), Addendum 1, (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to study product * Adverse events Grade 2 or higher as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009)
Pharmacokinetics: Assessments of systemic and local concentrations of dapivirine and maraviroc in plasma, vaginal fluids and cervical tissue, respectively
Time frame: 7.5 weeks
Assessed during and after 28 days' of continuous use of a vaginal ring containing 25 mg dapivirine, or 100 mg maraviroc, or 25 mg dapivirine + 100 mg maraviroc.
2 secondary outcomes
Evaluate the acceptability of the study VR in HIV-uninfected sexually abstinent women over 28 days of use
Time frame: 28 days
Evaluate the adherence to the study VR in HIV-uninfected sexually abstinent women over 28 days of use
Time frame: 28 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 10 Sep 2015.
- Background: PubMed 26034880Chen BA, Panther L, Marzinke MA, Hendrix CW, Hoesley CJ, van der Straten A, Husnik MJ, Soto-Torres L, Nel A, Johnson S, Richardson-Harman N, Rabe LK, Dezzutti CS. Phase 1 Safety, Pharmacokinetics, and Pharmacodynamics of Dapivirine and Maraviroc Vaginal Rings: A Double-Blind Randomized Trial. J Acquir Immune Defic Syndr. 2015 Nov 1;70(3):242-9. doi: 10.1097/QAI.0000000000000702.
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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.
Beatrice A Chen, MD, MPH study chair
University of Pittsburgh
Lori Panther, MD, MPH study chair
The Fenway Institute
3 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 Vaginal Ring, Maraviroc Vaginal Ring and Dapivirine-Maraviroc Vaginal Ring in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 3 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 11 inclusion and 27 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 10 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Safety: To assess and compare safety of VRs containing 25 mg dpv, or 100 mg mrv, or 25 mg dpv + 100 mg mrv, the endpoint was the proportion of women in the four arms experiencing specific, protocol defined safety events during the study (see description) (time frame: 7.5 weeks). The study lists 2 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 NCT01363037, 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 10 Sep 2015.