HIV InfectionsPhase 1NCT05416021
Relative Bioavailability Trial of Dapivirine Ring-004 and Ring-008
A Phase 1 study testing dapivirine in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 1 site in South Africa.
Trial summary
A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Aug 2022to 2 Jul 2024
- 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
- Assigned female sex at birth per participant report*
- Age 18 through 45 years (inclusive) at Screening, verified by national identification book/card
- Able and willing to provide written informed consent to be screened for and enrolled in IPM 054
- Able and willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures, eg, by home visit or telephone, or via family or close neighbour contacts (confidentiality to be maintained)
- Able to complete a diary card
- Available for all visits and able and willing to comply with all trial procedural requirements
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- Willing to comply with abstinence and other protocol requirements
- Willing to use male condoms for penile-vaginal intercourse and penile-rectal intercourse for the duration of trial participation
- Per participant report; using an effective method of contraception for at least 30 days (inclusive) prior to Enrolment, and intending to continue use of an effective method for the duration of trial participation; effective methods include:
- hormonal methods (except a contraceptive ring)
- intrauterine device (IUD); with no vaginal or gynaecological complaints associated with its use prior to enrolment
- sterilisation of participant at least 3 months prior to enrolment Note: Women not at risk of becoming pregnant by virtue of having had a partial hysterectomy or having sex exclusively with cisgender women may be enrolled.
- In general good health as determined by the Investigator/designee at Screening and Enrolment
- Human Immunodeficiency Virus (HIV)-negative as determined by an HIV test at the time of screening and enrolment
- Per participant report at Screening, regular menstrual cycles with at least 21 days between menses
- Per participant report at Screening and Enrolment, states a willingness to refrain from inserting any non-trial vaginal products or objects into the vagina including, but not limited to tampons, spermicides, female condoms, diaphragms, intravaginal rings, vaginal medications, menstrual cups, cervical caps, douches, lubricants, and sex toys (vibrators, dildos, etc.) for the duration of trial participation
- Upon pelvic examination (using a speculum) at the time of Enrolment, the cervix and vagina appear normal as determined by the Investigator/Physician
- Willing to refrain from participation in any other research trial for the duration of this trial
Who cannot join
- 1) Pregnant at Screening or Enrolment or plans to become pregnant during the trial period* 2) Diagnosed with a urinary tract infection (UTI) or reproductive tract infection (RTI) at Screening or Enrolment based on clinical assessment* 3) Diagnosed with an acute sexually transmitted infection (STI) requiring treatment per current local guidelines at Screening such as gonorrhoea (GC), chlamydia trachomatis (CT), trichomonas, and/or syphilis* 4) Has an abnormal cytology finding at screening or clinically apparent Grade 1 or higher pelvic examination finding (observed by trial staff) at Screening or Enrolment, as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, and/or Addendum (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007])* 5) Participant report and/or clinical evidence of any of the following:*
- Known adverse reaction to any of the trial products (ever)
- Chronic and/or recurrent vaginal candidiasis
- Misuse of legal and illegal medication or substances in the 12 months prior to Enrolment
- Last pregnancy outcome less than 90 days prior to Enrolment
- Gynaecologic or genital procedure (eg, tubal ligation, dilation and curettage, piercing) 45 days or less prior to Enrolment Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap test as well as IUD insertion/removal are not exclusionary.
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- Currently breastfeeding or planning to breastfeed during the trial period
- Participation in any other research trial involving drugs, medical devices, vaginal products or vaccines, in the 60 days prior to Enrolment 6) Completed use of oral pre-exposure prophylaxis (PrEP) for HIV prevention and/or post-exposure prophylaxis (PEP) for potential HIV exposure within one month prior to screening, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation 7) Has any Grade 1 or higher laboratory abnormalities at the Screening Visit 8) Participant has a positive test for Hepatitis B surface antigen (HBsAg) or is Hepatitis C virus antibody (HCV-Ab) positive 9) Participant has a positive urine drug test or a positive alcohol breath test.
- 10) Has any other condition that, in the opinion of the Investigator, would preclude informed consent, make trial participation unsafe, complicate the interpretation of trial outcome data, or otherwise interfere with achieving the trial objectives including any significant uncontrolled active or chronic medical condition 11) Has plans to relocate away from the trial site area after starting the trial and unable to return for trial visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 Inserted Every 30 Days and 100 mg DPV Ring-008 Inserted for 90 Days in Healthy Female Participants
A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants
Read the detailed description
IPM 054 is a Phase I, open-label, randomized, crossover trial to determine the relative bioavailability in plasma and vaginal fluid of two formulations of the dapivirine vaginal ring in HIV-negative women. The trial will compare the dapivirine concentrations achieved in plasma and vaginal fluid over all timepoints for each 90-day use period in a two-period, two-sequence, crossover design.
Participants will be randomized to one of two treatment sequences (AB or BA). During two consecutive 90-day treatment periods, the participants will receive each of the following treatments according to their assigned treatment sequence. The treatment periods will be separated by a 28-day washout period.
Treatment Sequence 1:
- 25 mg dapivirine ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A), followed by the 100 mg dapivirine ring (Ring-008) used continuously for 90 days (Treatment B)
Treatment Sequence 2:
- 100 mg dapivirine ring (Ring-008) used continuously for 90 days (Treatment B), followed by the 25 mg dapivirine ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A)
- Conditions
- HIV Infections
- Being tested
- dapivirine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dapivirineDrug
dapivirine vaginal ring
| Study group | Role | What they receive |
|---|---|---|
| 25 mg dapivirine ring | Active comparator | 25 mg dapivirine vaginal ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A), followed by the 100 mg dapivirine ring (Ring-008) used continuously for 90 days (Treatment B) Receives: Drug: dapivirine |
| 100 mg dapivirine ring | Active comparator | 100 mg dapivirine vaginal ring (Ring-008) used continuously for 90 days (Treatment B), followed by the 25 mg dapivirine ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A) Receives: Drug: dapivirine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the relative bioavailability of Dapivirine Vaginal Ring-008 compared to Dapivirine Vaginal Ring-004 by comparison of dapivirine plasma pharmacokinetic parameters.
Dapivirine concentrations in plasma, measured at specified timepoints during each 90-day ring use period.
Measured: during a 90 day use period
Secondary outcomes (4)
To further characterize the pharmacokinetic profile of Dapivirine Vaginal Ring-008 compared to Dapivirine Vaginal Ring-004 in vaginal fluid
Dapivirine concentrations in vaginal fluid, measured at specified timepoints during each 90-day ring use period, and for 1 day following ring removal. Vaginal fluid samples will be collected using tear test strips at the location of the cervix.
Measured: during each 90 days ring use period
To evaluate the incidence of Grade 1 or higher genitourinary treatment-emergent adverse events and the incidence of Grade 3 or higher treatment-emergent adverse events of the two dapivirine vaginal ring formulations used continuously for 90 days
Evaluating the incidence of treatment-emergent adverse events with severity grades as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, and/or Addendum 1 (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007]).
Measured: during each 90 days ring use period
To assess the effects on vaginal flora when using Dapivirine Vaginal Ring-004 and Dapivirine Vaginal Ring-008 formulations used continuously for 90 days
Assessing the effects by evaluating changes in vaginal pH from baseline and the incidence of bacterial vaginosis, assessed by Nugent scores of ≥ 7, determined from vaginal specimens collected for Gram staining.
Measured: during each 90 days ring use period
To characterize the vaginal microenvironment over the course 90 days of ring use.
The amount of dapivirine released over three 30-day periods (ie, 90 days) for Ring-004 and over 90 days for Ring-008. Residual dapivirine levels in used rings
Measured: during a 90 day use period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Aug 2022
- Primary completion2 Apr 2024
- Study completion2 Jul 2024
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
- Crossover
- Model description
- Participants will be randomized to one of two treatment sequences (AB or BA). During two consecutive 90-day treatment periods, the participants will receive each of the following treatments according to their assigned treatment sequence. The treatment periods will be separated by a 28-day washout period.
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Partnership for Microbicides, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anél Dr Pretorius, MB ChB, Principal investigator, FARMOVS Pty Ltd, Bloemfontein, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416021
- Sponsor's protocol ID
- IPM 054
- Status last verified
- Jul 2024
- First submitted
- 14 Apr 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 Inserted Every 30 Days and 100 mg DPV Ring-008 Inserted for 90 Days in Healthy Female Participants
- ClinicalTrials.gov ID
- NCT05416021
- Acronym / sponsor ID
- IPM 054
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- International Partnership for Microbicides, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 13 Jun 2022 (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.
A Phase I, Open-Label, Randomized, Crossover Trial to Investigate the Relative Bioavailability of the 25 mg Dapivirine Vaginal Ring-004 inserted every 30 days and 100 mg Dapivirine Vaginal Ring-008 inserted for 90 days in Healthy Female Participants
Detailed description
IPM 054 is a Phase I, open-label, randomized, crossover trial to determine the relative bioavailability in plasma and vaginal fluid of two formulations of the dapivirine vaginal ring in HIV-negative women. The trial will compare the dapivirine concentrations achieved in plasma and vaginal fluid over all timepoints for each 90-day use period in a two-period, two-sequence, crossover design.
Participants will be randomized to one of two treatment sequences (AB or BA). During two consecutive 90-day treatment periods, the participants will receive each of the following treatments according to their assigned treatment sequence. The treatment periods will be separated by a 28-day washout period.
Treatment Sequence 1:
- 25 mg dapivirine ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A), followed by the 100 mg dapivirine ring (Ring-008) used continuously for 90 days (Treatment B)
Treatment Sequence 2:
- 100 mg dapivirine ring (Ring-008) used continuously for 90 days (Treatment B), followed by the 25 mg dapivirine ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized to one of two treatment sequences (AB or BA). During two consecutive 90-day treatment periods, the participants will receive each of the following treatments according to their assigned treatment sequence. The treatment periods will be separated by a 28-day washout period.
| Arm | Type | Receives |
|---|---|---|
| 25 mg dapivirine ring | Active comparator | Drug: dapivirine25 mg dapivirine vaginal ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A), followed by the 100 mg dapivirine ring (Ring-008) used continuously for 90 days (Treatment B) |
| 100 mg dapivirine ring | Active comparator | Drug: dapivirine100 mg dapivirine vaginal ring (Ring-008) used continuously for 90 days (Treatment B), followed by the 25 mg dapivirine ring (Ring-004) for 90 days (replaced every 30 days) (Treatment A) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Assigned female sex at birth per participant report*
- Age 18 through 45 years (inclusive) at Screening, verified by national identification book/card
- Able and willing to provide written informed consent to be screened for and enrolled in IPM 054
- Able and willing to provide adequate locator information for trial retention purposes and be reachable per local standard procedures, eg, by home visit or telephone, or via family or close neighbour contacts (confidentiality to be maintained)
- Able to complete a diary card
Key exclusion criteria (9 listed)
- 1) Pregnant at Screening or Enrolment or plans to become pregnant during the trial period* 2) Diagnosed with a urinary tract infection (UTI) or reproductive tract infection (RTI) at Screening or Enrolment based on clinical assessment* 3) Diagnosed with an acute sexually transmitted infection (STI) requiring treatment per current local guidelines at Screening such as gonorrhoea (GC), chlamydia trachomatis (CT), trichomonas, and/or syphilis* 4) Has an abnormal cytology finding at screening or clinically apparent Grade 1 or higher pelvic examination finding (observed by trial staff) at Screening or Enrolment, as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017, and/or Addendum (Female Genital Grading Table for Use in Microbicide Studies [Dated November 2007])* 5) Participant report and/or clinical evidence of any of the following:*
- 10) Has any other condition that, in the opinion of the Investigator, would preclude informed consent, make trial participation unsafe, complicate the interpretation of trial outcome data, or otherwise interfere with achieving the trial objectives including any significant uncontrolled active or chronic medical condition 11) Has plans to relocate away from the trial site area after starting the trial and unable to return for trial visits
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 |
|---|---|---|
| dapivirinedapivirine vaginal ring | Drug | 100 mg dapivirine ring, 25 mg dapivirine ring |
Primary outcome
To determine the relative bioavailability of Dapivirine Vaginal Ring-008 compared to Dapivirine Vaginal Ring-004 by comparison of dapivirine plasma pharmacokinetic parameters.
Time frame: during a 90 day use period
Dapivirine concentrations in plasma, measured at specified timepoints during each 90-day ring use period.
4 secondary outcomes
To further characterize the pharmacokinetic profile of Dapivirine Vaginal Ring-008 compared to Dapivirine Vaginal Ring-004 in vaginal fluid
Time frame: during each 90 days ring use period
To evaluate the incidence of Grade 1 or higher genitourinary treatment-emergent adverse events and the incidence of Grade 3 or higher treatment-emergent adverse events of the two dapivirine vaginal ring formulations used continuously for 90 days
Time frame: during each 90 days ring use period
To assess the effects on vaginal flora when using Dapivirine Vaginal Ring-004 and Dapivirine Vaginal Ring-008 formulations used continuously for 90 days
Time frame: during each 90 days ring use period
To characterize the vaginal microenvironment over the course 90 days of ring use.
Time frame: during a 90 day use period
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 3 Jul 2024.
- 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.
Anél Dr Pretorius, MB ChB principal investigator
FARMOVS Pty Ltd, Bloemfontein, South Africa
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 in people with HIV Infections, run by International Partnership for Microbicides, Inc. at 1 site in South Africa.
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 18 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: finished, as of the sponsor's last update on 3 Jul 2024. 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 South Africa. 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?
To determine the relative bioavailability of Dapivirine Vaginal Ring-008 compared to Dapivirine Vaginal Ring-004 by comparison of dapivirine plasma pharmacokinetic parameters. (time frame: during a 90 day use period). 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 3 Jul 2024.