A Phase 1 interventional study of dapivirine in HIV Infections, sponsored by International Partnership for Microbicides, Inc.. Completed at 1 site in South Africa. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by International Partnership for Microbicides, Inc. (part of Population Council) · Phase 1, Interventional, and Prevention
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
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:
Treatment Sequence 2:
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's enrollment of 124 is above the median of 80 across 3,489 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →International Partnership for Microbicides, Inc. is the lead sponsor of 45 studies on the registry; none are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 5 (38%) have results posted.
First submitted before International Partnership for Microbicides, Inc. became part of Population Council.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Per participant report; using an effective method of 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:
Exclusion Criteria:
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:*
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 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 surface antigen (HBsAg) or is virus antibody (HCV-Ab) positive 9) Participant has a positive urine drug test or a positive alcohol breath test.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Drug: dapivirine
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)
Drug: dapivirine
dapivirine vaginal ring
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.
Time frame: during a 90 day use period
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.
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
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 \[Dated November 2007\]).
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
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.
Time frame: 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
Time frame: during a 90 day use period
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dapivirine
International Partnership for Microbicides, Inc. →