HIV InfectionsPhase 1NCT03239483

Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

A Phase 1 study testing Dapivirine gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%) administered rectally to HIV-1 seronegative adults. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: Dapivirine gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 3 sitesin 2 countries
Study dates: 26 Oct 2017to 20 Sep 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Age of 18 - 45 years (inclusive) at Screening, verified per site standard operating procedure (SOP)
Able and willing to provide written informed consent
HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II of the protocol and willing to receive HIV test results
Able and willing to provide adequate locator information, as defined in site SOP
Available to return for all study visits and willing to comply with study participation requirements
In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee

Show all 15Show fewer

Per participant report, a history of consensual receptive anal intercourse (RAI) at least once in the past calendar year
Willing to not take part in other research studies involving drugs, medical devices, genital or rectal products, or vaccines for the duration of study participation, including the time between Screening and Enrollment
Willing to be sexually abstinent for 72 hours prior to each study visit, during the study product use periods and for 72 hours after biopsy collection. Note: See Criteria 12 and 13 for additional restrictions for female participants
Willing to abstain from inserting any non-study products into the rectum for 72 hours prior to each study visit and during the study product use periods. Note: See Criteria 12 and 13 for additional restrictions for female participants
Females must also meet the following additional inclusion criteria to be eligible for study inclusion:
Women over the age of 21 (inclusive) must have documentation of a satisfactory Pap within the past 3 years prior to Enrollment consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 (dated November 2007) to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017, or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result
Willing to be sexually abstinent for 72 hours prior to each study visit and during the study product use periods and for 7 days after biopsy collection
Willing to abstain from inserting any non-study products into the vagina for 72 hours prior to each study visit, during the study product use periods and for 7 days after biopsy collection
Willing to use an effective method of contraception for at least 30 days (inclusive) prior to Enrollment and intending to continue use of an effective method for the duration of study participation; effective methods include: hormonal methods (except contraceptive ring), intrauterine device (IUD), sterilization (of participant and/or partner, as defined in site SOPs), or sexually abstinent for 90 days prior to Screening

Who cannot join

At Screening:
Hemoglobin Grade 1 or higher*
Platelet count Grade 1 or higher*
White blood count Grade 2 or higher*
Serum creatinine greater than 1.3× the site laboratory upper limit of normal (ULN)
International normalized ratio (INR) greater than 1.5× the site laboratory ULN

Show all 37Show fewer

Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher*
Positive for hepatitis C antibody
Positive for hepatitis B surface antigen
History of inflammatory bowel disease by participant report
*As per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events Corrected Version 2.1, July 2017
Note: Otherwise eligible participants with an exclusionary test result (other than HIV, HBV or HCV) can be re-tested during the screening process. If a participant is re-tested and a non-exclusionary result is documented within 45 days of providing informed consent for screening, the participant may be enrolled.
Anticipated use of and/or unwillingness to abstain from the following medications during study participation:
Heparin, including Lovenox®
Warfarin
Plavix® (clopidogrel bisulfate)
Aspirin (greater than 81 mg)
Non-steroidal anti-inflammatory drugs (NSAIDS)
Any other drugs that are associated with increased likelihood of bleeding
CYP3A inducer(s) and/or inhibitor(s) as specified in the MTN-026 Study-Specific Procedures (SSP) Manual
Hormone-replacement therapy in tablet, injectable or gel form
Known adverse reaction to any of the components of the study products
Use of post-exposure prophylaxis (PEP) for potential HIV exposure within the 6 months prior to Enrollment
Use of pre-exposure prophylaxis (PrEP) for HIV prevention within the 6 months prior to Enrollment, and/or anticipated use during trial participation
Use of systemic immunomodulatory medications within the 6 months prior to Enrollment, and/or anticipated use during trial participation
RAI without a condom and/or penile-vaginal intercourse with a partner who is known to be HIV-positive in the past 6 months
Non-therapeutic injection drug use in the 12 months prior to Screening and Enrollment
Participation in research studies involving drugs, medical devices, genital or rectal products, or vaccines within 45 days of the Enrollment Visit
At Screening, participant report of treatment for an anogenital STI within the past 3 months
At Screening, participant-reported symptoms and/or clinical or laboratory diagnosis of active anorectal or reproductive tract infection requiring treatment per current World Health Organization (WHO) guidelines (http://www.who.int/hiv/pub/sti/pub6/en/) or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic Neisseria gonorrhea (GC), Chlamydia trachomatis (CT) infection, syphilis, active herpes simplex virus (HSV) lesions, anogenital sores or ulcers, or symptomatic genital warts, cervicitis, chancroid, pelvic inflammatory disease (PID), bacterial vaginosis (BV), symptomatic vaginal candidiasis, other vaginitis, trichomoniasis. Note: Otherwise eligible participants with an exclusionary UTI, BV and/or candida finding may be re-tested during the screening process.
At Enrollment, active anorectal or reproductive tract infection requiring treatment per current WHO guidelines (http://www.who.int/hiv/pub/sti/pub6/en/) or symptomatic urinary tract infection (UTI). Infections requiring treatment include symptomatic GC, CT, syphilis, active HSV lesions, anogenital sores or ulcers, symptomatic genital warts, bacterial vaginosis, symptomatic vaginal candidiasis, other vaginitis, trichomoniasis, chancroid, cervicitis and PID. Note: HSV-1 or HSV-2 seropositive diagnosis with no active lesions is permitted since treatment is not required
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.
Females who meet any of the following additional criteria will be excluded from the study:
Pregnant or breastfeeding at either Screening or Enrollment or intends to become pregnant or start breastfeeding during study participation. Note: A documented negative pregnancy test performed by study staff is required for inclusion; however, a self-reported pregnancy is adequate for exclusion from screening/enrollment into the study.
Last pregnancy outcome 90 days or less prior to Screening
Has had a hysterectomy
At Enrollment, has a clinically apparent Grade 1 or higher pelvic exam finding (observed by study clinician or designee) per the Female Genital Grading Table for Use in Microbicide Studies [Addendum 1, Dated November 2007]. 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.

Trial locations and contacts

3 sites in 2 countries.

Country

City, postcode or hospital

3 sites in 2 countries

United States2 sites

Alabama CRS
Birmingham, Alabama, 35294
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213

Other trials in United States

Thailand1 site

Silom Community Clinic CRS
Nonthaburi, Bangkok, 11000

Other trials in Thailand

About this study

Official title: A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults

The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%) administered rectally to HIV-1 seronegative adults.

Read the detailed description

This study will evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%) administered rectally to HIV-1 seronegative adults.

Participants will be randomized to receive a single dose of either rectally administered dapivirine gel (0.05%) or placebo gel at study entry (Day 0). Following a minimum 2-week washout period, participants or study staff will administer daily rectal doses of the assigned gel for 7 consecutive days under direct observation in the clinic.

Participants will be in the study for approximately 40 days, and they will attend 16 study visits. Study visits may include behavioral assessments, physical examinations, blood and urine collection, and pelvic and anorectal sample collection. Some visits will include intensive PK sampling. Study staff will contact participants 1 week after Visit 16 for follow-up safety monitoring.

Conditions: HIV Infections
Being tested: Dapivirine gel, Placebo gel
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 gelDrug
Dapivirine gel (0.05%); administered rectally
Placebo gelDrug
Universal HEC placebo gel; administered rectally

Study groups in NCT03239483
Study group	Role	What they receive
Dapivirine gel	Experimental	Participants will receive a single dose of dapivirine gel rectally, followed by 7 daily doses of dapivirine gel to be administered under direct observation in the clinic. Receives: Drug: Dapivirine gel
Placebo gel	Placebo comparator	Participants will receive a single dose of placebo gel rectally, followed by 7 daily doses of placebo gel to be administered under direct observation in the clinic. Receives: Drug: Placebo gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Grade 2 or Higher Adverse Events (AEs)
As defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1, 2 and 3 (Female Genital [Dated November 2007], Male Genital [Dated November 2007] and Rectal [Clarification Dated May 2012] Grading Tables for Use in Microbicide Studies)
Measured: Measured after the participant has started study product until the participant's study termination at approximately Day 40
Measurement of Dapivirine Concentrations in Plasma
As assessed by pharmacokinetic sampling and analysis
Measured: Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose, 24 hours after first dose during daily dosing, before last dose and 1,2, 24,48, and 72 hours after last dose.
Measurement of Dapivirine Concentrations in Rectal Fluid
As assessed by pharmacokinetic rectal fluid sampling and analysis
Measured: Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose, 24 hours after first dose during daily dosing, and 1,2, 24,48, and 72 hours after last dose.
Measurement of Dapivirine Concentrations in Rectal Mucosal Tissue Homogenates
As assessed by pharmacokinetic rectal mucosal tissue homogenates sampling and analysis
Measured: Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose and 1,2, 24,48, and 72 hours after last dose.
Terminal Half-life of Dapivirine Concentrations in Plasma
The terminal half-life of dapivirine in plasma samples was estimated by fitting a linear regression on the log-transformed concentrations from the 24, 48 and 72 hour time-points after the single and multiple doses.Each regression model includes an adjustment for the difference in concentration after multiple dosing. For each participant, Beta was calculated as the negative of the slope of their repression and half-life was log(2)/Beta. Due to the large number of concentrations below the limit of quantification after the single dose, the estimateion of Beta and half-life relied only on concentration after the multiple dosing for most of the participants.
Measured: From samples collected 24 hours after first dose to 72 hours after last daily dose

Secondary outcomes (2)

Acceptability: Ease of Use
The number of participants who responded by questionnaire that the study product was easy or very easy to use.
Measured: after completing the study (study day 40)
Acceptability: Comfort
The number of participants who responded on a questionnaire that the study product was comfortable or very comfortable.
Measured: after completing the study (study day 40)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Oct 201720 Sep 2018

First posted4 Aug 2017
Study start26 Oct 2017
Primary completion20 Sep 2018
Study completion20 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03239483
Sponsor's protocol ID: MTN-026
Other IDs: 12021
Status last verified: Oct 2019
First submitted: 2 Aug 2017
Last updated: 19 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Bauermeister JA, Tingler RC, Dominguez C, Dunne EF, Hoesley C, Ho K, Johnson S, Lucas J, Macagna N, Brown E, Gundacker H, Peda M, Jacobson CE, Kramzer L, Singh D, Dezzutti CS, Ayudhya RPKN, Marzinke MA, Piper J, Devlin B, Nuttall J, McGowan I, Hendrix CW, Cranston RD; MTN 026 team. Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026). AIDS Behav. 2022 May;26(5):1333-1346. doi: 10.1007/s10461-021-03490-8. Epub 2021 Oct 17.
PubMed 34657218
Cranston RD, Brown E, Bauermeister J, Dunne EF, Hoesley C, Ho K, Johnson S, Lucas J, Dominguez-Islas C, Gundacker H, Peda M, Jacobson CE, Kramzer L, Singh D, Dezzutti CS, Kunjara Na Ayudhya RP, Brand RM, Wang L, Marzinke MA, Piper J, Devlin B, Nuttall J, McGowan I, Hendrix CW. A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety, and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults (MTN-026). AIDS Res Hum Retroviruses. 2022 Apr;38(4):257-268. doi: 10.1089/AID.2021.0071. Epub 2021 Dec 6.
PubMed 34498980

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults
ClinicalTrials.gov ID: NCT03239483
Acronym / sponsor ID: MTN-026
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 26 Oct 2017 (actual)
Primary completion: 20 Sep 2018 (actual)
Study completion: 20 Sep 2018 (actual)
First posted: 4 Aug 2017 (actual)
Results: Posted 7 Nov 2019

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 evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%) administered rectally to HIV-1 seronegative adults.

Detailed description

This study will evaluate the safety and pharmacokinetics (PK) of dapivirine gel (0.05%) administered rectally to HIV-1 seronegative adults.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dapivirine gel	Experimental	Drug: Dapivirine gelParticipants will receive a single dose of dapivirine gel rectally, followed by 7 daily doses of dapivirine gel to be administered under direct observation in the clinic.
Placebo gel	Placebo comparator	Drug: Placebo gelParticipants will receive a single dose of placebo gel rectally, followed by 7 daily doses of placebo gel to be administered under direct observation in the clinic.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (15 listed)

Age of 18 - 45 years (inclusive) at Screening, verified per site standard operating procedure (SOP)
Able and willing to provide written informed consent
HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in Appendix II of the protocol and willing to receive HIV test results
Able and willing to provide adequate locator information, as defined in site SOP
Available to return for all study visits and willing to comply with study participation requirements

Key exclusion criteria (37 listed)

At Screening:
Anticipated use of and/or unwillingness to abstain from the following medications during study participation:
Known adverse reaction to any of the components of the study products
Use of post-exposure prophylaxis (PEP) for potential HIV exposure within the 6 months prior to Enrollment
Use of pre-exposure prophylaxis (PrEP) for HIV prevention within the 6 months prior to Enrollment, and/or anticipated use during trial participation

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 gelDapivirine gel (0.05%); administered rectally	Drug	Dapivirine gel
Placebo gelUniversal HEC placebo gel; administered rectally	Drug	Placebo gel

Primary outcome

Frequency of Grade 2 or Higher Adverse Events (AEs)
Time frame: Measured after the participant has started study product until the participant's study termination at approximately Day 40
As defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 and/or Addenda 1, 2 and 3 (Female Genital [Dated November 2007], Male Genital [Dated November 2007] and Rectal [Clarification Dated May 2012] Grading Tables for Use in Microbicide Studies)
Measurement of Dapivirine Concentrations in Plasma
Time frame: Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose, 24 hours after first dose during daily dosing, before last dose and 1,2, 24,48, and 72 hours after last dose.
As assessed by pharmacokinetic sampling and analysis
Measurement of Dapivirine Concentrations in Rectal Fluid
Time frame: Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose, 24 hours after first dose during daily dosing, and 1,2, 24,48, and 72 hours after last dose.
As assessed by pharmacokinetic rectal fluid sampling and analysis
Measurement of Dapivirine Concentrations in Rectal Mucosal Tissue Homogenates
Time frame: Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose and 1,2, 24,48, and 72 hours after last dose.
As assessed by pharmacokinetic rectal mucosal tissue homogenates sampling and analysis
Terminal Half-life of Dapivirine Concentrations in Plasma
Time frame: From samples collected 24 hours after first dose to 72 hours after last daily dose
The terminal half-life of dapivirine in plasma samples was estimated by fitting a linear regression on the log-transformed concentrations from the 24, 48 and 72 hour time-points after the single and multiple doses.Each regression model includes an adjustment for the difference in concentration after multiple dosing. For each participant, Beta was calculated as the negative of the slope of their repression and half-life was log(2)/Beta. Due to the large number of concentrations below the limit of quantification after the single dose, the estimateion of Beta and half-life relied only on concentration after the multiple dosing for most of the participants.

2 secondary outcomes

Acceptability: Ease of Use
Time frame: after completing the study (study day 40)
Acceptability: Comfort
Time frame: after completing the study (study day 40)

Results and safety

Results posted to the registry on 7 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapivirine Gel	19	17
Placebo Gel	9	9

Primary outcome: Frequency of Grade 2 or Higher Adverse Events (AEs)

Time frame: Measured after the participant has started study product until the participant's study termination at approximately Day 40. Count of participants. Unit: Participants

Measure	Dapivirine Gel n = 18	Placebo Gel n = 9
Value	3	5

Dapivirine Gel vs Placebo Gel: p = 0.072, Fisher Exact

Population analysed: enrolled participants receiving at least one dose of study product

Primary outcome: Measurement of Dapivirine Concentrations in Plasma

Time frame: Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose, 24 hours after first dose during daily dosing, before last dose and 1,2, 24,48, and 72 hours after last dose.. Median (Inter-Quartile Range). Unit: pg/mL

Measure	Dapivirine Gel n = 18
30 to 60 minutes after single dose	31.5 (0 to 54.6)
120 minutes after single dose	326 (153 to 481)
24 hours after single dose	20.1 (0 to 56.6)
48 hours after single dose	0 (0 to 27.3)
72 hours after single dose	0 (0 to 0)
24 hours after first daily dose	67.9 (43.1 to 111.0)
Before last daily dose	167 (136 to 219)
30 to 60 minutes after last daily dose	290.5 (147.0 to 506.5)

Population analysed: enrolled participants on the Dapivirine arm who received at least one dose of study product and had a sample collected at the specific time-point. 0 is an estimate for values below the limit of quantification (LLOQ = 20 pg/mL) since only numeric values are allowed. The value would be somewhere between the LLOQ and 0.

Primary outcome: Measurement of Dapivirine Concentrations in Rectal Fluid

Time frame: Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose, 24 hours after first dose during daily dosing, and 1,2, 24,48, and 72 hours after last dose.. Median (Inter-Quartile Range). Unit: ng/mg

Measure	Dapivirine Gel n = 18
30 to 60 minutes after first application	30.1 (16.1 to 43.9)
120 minutes after single dose	12.765 (6.055 to 141.500)
24 hours after single dose	0 (0 to 0.016)
48 hours after single dose	0.009 (0 to 0.038)
72 hours after single dose	0 (0 to 0)
24 hours after first daily dose	0.180 (0 to 1.910)
30 to 60 minutes after last daily dose	89.7 (44.9 to 258.0)
120 minutes after last daily dose	26.65 (4.95 to 278.50)

Population analysed: enrolled participants on the Dapivirine arm who received at least one dose of product and had a sample collected at the specific time-point. 0 is an estimate for values below the limit of quantification (LLOQ = 0.001 ng/mg) since only numeric values are allowed. The value would be somewhere between the lower limit of quantification and 0.

Primary outcome: Measurement of Dapivirine Concentrations in Rectal Mucosal Tissue Homogenates

Time frame: Sample collected at approximately 1, 2, 24, 48 and 72 hours after first single dose and 1,2, 24,48, and 72 hours after last dose.. Median (Inter-Quartile Range). Unit: ng/mg

Measure	Dapivirine Gel n = 18
30 to 60 minutes after single dose	0.256 (0 to 0.666)
120 minutes after single dose	0 (0 to 0.600)
24 hours after single dose	0 (0 to 0)
48 hours after single dose	0 (0 to 0)
72 hours after single dose	0 (0 to 0)
30 to 60 minutes after last daily dose	0 (0 to 0)
120 minutes after last daily dose	0 (0 to 0.151)
24 hours after last daily dose	0 (0 to 0)

Population analysed: enrolled participants on the Dapivirine gel arm who received at least one dose of study product and had a sample collected at the specific time-point. 0 is an estimate for values below the limit of quantification (LLOQ = 0.001 ng/mg) since only numeric values are allowed. The value would be somewhere between the LLOQ and 0.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected through study completion (between 40 to 86 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapivirine Gel	0 of 18 (0%)	6 of 18 (33.3%)	0 of 18
Placebo Gel	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34657218Bauermeister JA, Tingler RC, Dominguez C, Dunne EF, Hoesley C, Ho K, Johnson S, Lucas J, Macagna N, Brown E, Gundacker H, Peda M, Jacobson CE, Kramzer L, Singh D, Dezzutti CS, Ayudhya RPKN, Marzinke MA, Piper J, Devlin B, Nuttall J, McGowan I, Hendrix CW, Cranston RD; MTN 026 team. Acceptability of a Dapivirine/Placebo Gel Administered Rectally to HIV-1 Seronegative Adults (MTN-026). AIDS Behav. 2022 May;26(5):1333-1346. doi: 10.1007/s10461-021-03490-8. Epub 2021 Oct 17.
Derived from this study: PubMed 34498980Cranston RD, Brown E, Bauermeister J, Dunne EF, Hoesley C, Ho K, Johnson S, Lucas J, Dominguez-Islas C, Gundacker H, Peda M, Jacobson CE, Kramzer L, Singh D, Dezzutti CS, Kunjara Na Ayudhya RP, Brand RM, Wang L, Marzinke MA, Piper J, Devlin B, Nuttall J, McGowan I, Hendrix CW. A Randomized, Double Blind, Placebo-Controlled, Phase 1 Safety, and Pharmacokinetic Study of Dapivirine Gel (0.05%) Administered Rectally to HIV-1 Seronegative Adults (MTN-026). AIDS Res Hum Retroviruses. 2022 Apr;38(4):257-268. doi: 10.1089/AID.2021.0071. Epub 2021 Dec 6.

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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.

Ross D. Cranston, MD, FRCP study chair

Fundació Lluita Contra la Sida, Hospital Universitari Germans Trias I Pujol

3 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dapivirine gel in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in 2 countries.

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 15 inclusion and 37 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 19 Oct 2021. 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, Thailand. 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?

Yes. Results are posted in the registry (first posted 7 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Frequency of Grade 2 or Higher Adverse Events (AEs) (time frame: Measured after the participant has started study product until the participant's study termination at approximately Day 40). The study lists 5 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 NCT03239483, which also lists 2 linked publications.

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 19 Oct 2021.