HIV InfectionsPhase 1NCT04047420

Safety and Pharmacokinetic Study of Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Administered Rectally

A Phase 1 study testing TAF/EVG Insert in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: TAF/EVG Insert
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 2 sitesUnited States
Study dates: 11 Dec 2019to 7 Apr 2021
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Individuals who are 18 years of age or older at Screening, verified per site standard operating procedure (SOP)
Able and willing to provide written informed consent to be screened for and enrolled in MTN-039
HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in the study protocol and willing to receive HIV test results
Able and willing to provide adequate locator information, as defined in site SOP
Able to communicate in spoken and written English
Available for all visits and able and willing to comply with all study procedural requirements

Show all 16Show fewer

In general good health at Screening and Enrollment, as determined by the site Investigator of Record (IoR) or designee
At Screening, history of consensual receptive anal intercourse (RAI) at least once in lifetime per participant report
Willing not to 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 comply with abstinence and other protocol requirements as outlined in the study protocol
For participants of childbearing potential: a negative pregnancy test at Screening and Enrollment
For participants of childbearing potential: Per participant report at Enrollment, using an effective method of contraception for at least 30 days (inclusive) prior to Enrollment and intending to use an effective method for the duration of study participation. Effective methods include:
Hormonal methods
Intrauterine device (IUD) inserted at least 30 days prior to Enrollment (but not past the maximum length of recommended usage according to package instructions)
Sterilization (of participant or partner, as defined in site SOPs)
Sexually abstinent as defined by abstaining from penile-vaginal intercourse for 90 days prior to Enrollment and intending to remain abstinent for the duration of study participation; this includes having sex exclusively with individuals assigned female sex at birth

Who cannot join

At Screening:
Hemoglobin Grade 1 or higher*
Platelet count Grade 1 or higher*
Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher*
Serum creatinine greater than 1.3 times the site laboratory upper limit of normal (ULN)
International normalized ratio (INR) greater than 1.5 times the site laboratory ULN

Show all 30Show fewer

History of inflammatory bowel disease by participant report
Positive hepatitis B surface antigen (HBsAg) test result
*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) 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:
Anticoagulant medications
Non-study rectally-administered medications and any products containing nonoxynol-9 (N-9)
Known adverse reaction to any of the components of the study product
Use of approved or other investigational pre-exposure prophylaxis (PrEP) for HIV prevention within 3 months prior to Enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation
Use of post-exposure prophylaxis (PEP) for potential HIV exposure within 6 months prior to Enrollment
Condomless RAI and/or penile-vaginal intercourse with a partner who is known to be HIV-positive or whose status is unknown in the 6 months prior to Enrollment
History of transactional sex in the 12 months prior to Enrollment
Non-therapeutic injection drug use or use of non-therapeutic, non-injection stimulant drugs in the 12 months prior to Enrollment
Participation in research studies involving drugs, medical devices, genital or rectal products, or vaccines within 30 days of the Enrollment Visit
Per participant report, medical records, clinical diagnosis and/or diagnostic testing at either Screening or Enrollment:
Diagnosis or treatment of an anogenital sexually transmitted infection (STI) in the 3 months prior to enrollment (including window between Screening and Enrollment).
Symptoms, clinical or laboratory diagnosis of active pharyngeal, anorectal, or reproductive tract infection (RTI) requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines (http://www.cdc.gov/std/treatment).
Current symptomatic urinary tract infection (UTI).
Infections requiring treatment include Neisseria gonorrhea (GC), Chlamydia trachomatis (CT) infection, syphilis, active herpes simplex virus (HSV) lesions, or symptomatic genital warts, chancroid, pelvic inflammatory disease (PID), bacterial vaginosis (BV), symptomatic vaginal candidiasis, and trichomoniasis.
Note: Otherwise eligible participants with an exclusionary UTI, BV and/or candida finding may be re-tested during the screening process.
For participants of childbearing potential: Pregnant or breastfeeding at either Screening or Enrollment or planning to become pregnant 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.
For participants of childbearing potential: Last pregnancy outcome 90 days or less prior to Screening
Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate the interpretation of study outcome data, or otherwise interfere with achieving the study objectives including any significant uncontrolled active or chronic medical condition.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

Official title: A Phase 1 Open Label Safety and Pharmacokinetic Study of Rectal Administration of a Tenofovir Alafenamide/Elvitegravir Insert at Two Dose Levels

Read the detailed description

This study will evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals.

All participants will receive a single TAF/EVG Insert at Study Visit 3. After a washout period of at least 7 days, participants will receive two TAF/EVG Inserts at Study Visit 7. The inserts will be administered rectally by study staff. After each dosing visit, samples will be collected over a 3-day period.

Participants will attend 10 study visits and will be followed for approximately 6 to 13 weeks. Study visits may include physical and rectal examinations; collection of blood, urine, rectal and vaginal fluid; and interviews. The total duration of the study will be approximately 11 months.

Conditions: HIV Infections
Being tested: TAF/EVG Insert
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAF/EVG InsertDrug
TAF/EVG Insert (20/16 mg) administered rectally by study staff

Study groups in NCT04047420
Study group	Role	What they receive
Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert	Experimental	On the first dosing visit (Visit 3), participants will receive a single TAF/EVG Insert for rectal administration. On the second dosing visit (Visit 7), after a washout period of at least 7 days, participants will receive two TAF/EVG Inserts for rectal administration. Each participant will be on study for approximately 6-13 weeks. Receives: Drug: TAF/EVG Insert

What is being measured

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

Number of Participants With Grade 2 and Higher Adverse Events (AEs)
Graded per the Division of AIDS (DAIDS) Table for Grading 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 from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.
Elvitegravir (EVG) Concentration in Blood
Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose
Measured: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Elvitegravir (EVG) Concentration in Rectal Fluid
Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose
Measured: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Measured: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Tenofovir Alafenamide (TAF) Concentration in Blood
Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose
Measured: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid
Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose
Measured: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Measured: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Tenofovir (TFV) Concentration in Blood
Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose
Measured: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Tenofovir (TFV) Concentration in Rectal Fluid
Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose
Measured: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Measured: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Measured: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)

Secondary outcomes (3)

Participant Self-report Rectal Insert Acceptability - Ease of Use
Response for "Overall, how easy or difficult was it to use the study product when inserted by clinic staff?
Measured: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)
Participant Self-report Rectal Insert Acceptability - Feeling When Inserted
Response for "How did it feel to have the insert inside you?"
Measured: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert
Responses for questions related to problems with Rectal Insert
Measured: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)

Timeline

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

11 Dec 20197 Apr 2021

First posted6 Aug 2019
Study start11 Dec 2019
Primary completion3 Mar 2021
Study completion7 Apr 2021

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 (1)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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04047420
Sponsor's protocol ID: MTN-039
Other IDs: 38470
Status last verified: Dec 2023
First submitted: 5 Aug 2019
Last updated: 22 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Riddler SA, Kelly CW, Hoesley CJ, Ho KS, Piper JM, Edick S, Heard F, Doncel GF, Johnson S, Anderson PL, Brand RM, Kunjara Na Ayudhya RP, Bauermeister JA, Hillier SL, Hendrix CW. A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV Prevention. J Infect Dis. 2024 Sep 23;230(3):696-705. doi: 10.1093/infdis/jiae211.
PubMed 38655842

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?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Open Label Safety and Pharmacokinetic Study of Rectal Administration of a Tenofovir Alafenamide/Elvitegravir Insert at Two Dose Levels
ClinicalTrials.gov ID: NCT04047420
Acronym / sponsor ID: MTN-039
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Collaborators: CONRAD
Study start: 11 Dec 2019 (actual)
Primary completion: 3 Mar 2021 (actual)
Study completion: 7 Apr 2021 (actual)
First posted: 6 Aug 2019 (actual)
Results: Posted 22 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This study will evaluate the safety and pharmacokinetics of rectal administration of a tenofovir alafenamide (TAF)/elvitegravir (EVG) insert at two dose levels in HIV-uninfected individuals.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert	Experimental	Drug: TAF/EVG InsertOn the first dosing visit (Visit 3), participants will receive a single TAF/EVG Insert for rectal administration. On the second dosing visit (Visit 7), after a washout period of at least 7 days, participants will receive two TAF/EVG Inserts for rectal administration. Each participant will be on study for approximately 6-13 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Individuals who are 18 years of age or older at Screening, verified per site standard operating procedure (SOP)
Able and willing to provide written informed consent to be screened for and enrolled in MTN-039
HIV-1/2 uninfected at Screening and Enrollment, per applicable algorithm in the study protocol and willing to receive HIV test results
Able and willing to provide adequate locator information, as defined in site SOP
Able to communicate in spoken and written English

Key exclusion criteria (30 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 product
Use of approved or other investigational pre-exposure prophylaxis (PrEP) for HIV prevention within 3 months prior to Enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP during trial participation
Use of post-exposure prophylaxis (PEP) for potential HIV exposure within 6 months prior to 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
TAF/EVG InsertTAF/EVG Insert (20/16 mg) administered rectally by study staff	Drug	Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert

Primary outcome

Number of Participants With Grade 2 and Higher Adverse Events (AEs)
Time frame: Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.
Graded per the Division of AIDS (DAIDS) Table for Grading 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).
Elvitegravir (EVG) Concentration in Blood
Time frame: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose
Elvitegravir (EVG) Concentration in Rectal Fluid
Time frame: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose
Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates
Time frame: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Tenofovir Alafenamide (TAF) Concentration in Blood
Time frame: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose
Tenofovir Alafenamide (TAF) Concentration in Rectal Fluid
Time frame: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose
Tenofovir Alafenamide (TAF) Concentration in Rectal Mucosal Tissue Homogenates
Time frame: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Tenofovir (TFV) Concentration in Blood
Time frame: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Based on laboratory evaluations on samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours post dose
Tenofovir (TFV) Concentration in Rectal Fluid
Time frame: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Based on laboratory evaluations on samples collected at 2, 4, 6, 24, 48, and 72 hours post dose
Tenofovir (TFV) Concentration in Rectal Mucosal Tissue Homogenates
Time frame: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose
Tenofovir Diphosphate (TFV-DP) Concentration in Rectal Mucosal Tissue Cell Isolates
Time frame: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose)
Based on laboratory evaluations on samples collected at 2, 24, 48, and 72 hours post dose

3 secondary outcomes

Participant Self-report Rectal Insert Acceptability - Ease of Use
Time frame: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)
Participant Self-report Rectal Insert Acceptability - Feeling When Inserted
Time frame: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)
Participant Self-report Rectal Insert Acceptability - Problems With Rectal Insert
Time frame: 24 hours after each dose (Visits 4 and 8) (up to 9 weeks after first dose)

Results and safety

Results posted to the registry on 22 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tenofovir Alafenamide (TAF)/Elvitegravir (EVG) Insert	23	21

Primary outcome: Number of Participants With Grade 2 and Higher Adverse Events (AEs)

Time frame: Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.. Count of participants. Unit: Participants

Measure	One Insert n = 21	Two Inserts n = 19
Participants experiencing grade 2+ AE: Yes	1	1
Participants experiencing grade 2+ AE: No	20	18
Gastritis: Yes	0	1
Gastritis: No	21	18
Reactogenicity event: Yes	1	0
Reactogenicity event: No	20	19

Population analysed: All participants with dosing of one insert or two inserts.

Primary outcome: Elvitegravir (EVG) Concentration in Blood

Time frame: Samples collected at baseline (pre dose), 1, 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose). Median (Inter-Quartile Range). Unit: pg/mL

Measure	One Insert n = 21	Two Inserts n = 19
Baseline (Enrollment Visit)	NA (NA to NA)	–
1 hour postdosing	1010.0 (564.0 to 2050.0)	1510.0 (812.0 to 1890.0)
2 hours postdosing	1230 (605.0 to 3090.0)	2140.0 (1240.0 to 3420.0)
4 hours postdosing	1080.0 (450.0 to 1960.0)	1740.0 (933.0 to 3560.0)
6 hours postdosing	713.0 (441.0 to 1730.0)	1290.0 (825.0 to 2230.0)
24 hours postdosing	39.0 (NA to 201.5)	76.0 (35.0 to 471.0)
48 hours postdosing	NA (NA to NA)	NA (NA to NA)
72 hours postdosing	NA (NA to NA)	NA (NA to NA)

Population analysed: Baseline data were collected once at the enrollment visit prior to receiving both one insert and two inserts. Participants had post dose blood samples collected at 1, 2, 4, 6, 24, 48, and 72 hours (One insert (n=21); Two inserts (n=19))). Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))). Unable to draw sample (One insert (72-hours (n=1))).

Primary outcome: Elvitegravir (EVG) Concentration in Rectal Fluid

Time frame: Samples collected at 2, 4, 6, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose). Median (Inter-Quartile Range). Unit: ng/mL

Measure	One Insert n = 21	Two Inserts n = 19
2 hours postdosing	67542.0 (31652.0 to 338721.0)	176672.0 (50962.0 to 731606.0)
4 hours postdosing	125676.0 (72779.0 to 319693.0)	93888.5 (49922.0 to 236267.0)
6 hours postdosing	4095.5 (338.0 to 8708.0)	7791.0 (619.0 to 13131.0)
24 hours postdosing	2233.5 (574.0 to 3517.0)	2596.5 (89.1 to 18664.0)
48 hours postdosing	16.9 (2.1 to 278.0)	36.4 (1.0 to 807.5)
72 hours postdosing	5.9 (NA to 16.5)	29.1 (2.3 to 58.1)

Population analysed: Participants are randomly assigned 1:1 to post dose rectal fluid sampling at either 2, 6, and 48 hours (One insert (n=10); Two inserts (n=9)) or 4, 24, and 72 hours (One insert (n=11); Two inserts (n=10)). Missed sample collection (One insert (24-hour missed (n=1) but replaced by 48-hour sample); Two inserts (48-hour missed (n=1))).

Primary outcome: Elvitegravir (EVG) Concentration in Rectal Mucosal Tissue Homogenates

Time frame: Samples collected at 2, 24, 48, and 72 hours after each dose (up to 9 weeks after first dose). Median (Inter-Quartile Range). Unit: ng/mg

Measure	One Insert n = 21	Two Inserts n = 19
2 hours postdosing	5.4 (0.6 to 10.2)	9.0 (5.3 to 35.3)
24 hours postdosing	NA (NA to NA)	0.1 (NA to 0.7)
48 hours postdosing	NA (NA to NA)	NA (NA to NA)
72 hours postdosing	NA (NA to NA)	NA (NA to NA)

Population analysed: Participants are randomly assigned 1:1 to post dose rectal tissue sampling at either 2 and 48 hours (One insert (n=10)); Two inserts (n=9)) or 24 and 72 hours (One insert (n=11); Two inserts (n=10)). Missed sample collection (One insert (24-hour missed (n=1)); Two inserts (48-hour missed (n=1) and 72-hour missed (n=1))).

3 secondary outcomes are reported in the full results.

Adverse events

Group	Serious adverse events	Other adverse events	Deaths
Baseline (Pre-dosing)	0 of 23 (0%)	3 of 23 (13%)	0 of 23
One Insert	0 of 21 (0%)	4 of 21 (19%)	0 of 21
Two Inserts	0 of 19 (0%)	4 of 19 (21.1%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38655842Riddler SA, Kelly CW, Hoesley CJ, Ho KS, Piper JM, Edick S, Heard F, Doncel GF, Johnson S, Anderson PL, Brand RM, Kunjara Na Ayudhya RP, Bauermeister JA, Hillier SL, Hendrix CW. A Phase 1 Clinical Trial to Assess the Safety and Pharmacokinetics of a Tenofovir Alafenamide/Elvitegravir Insert Administered Rectally for HIV Prevention. J Infect Dis. 2024 Sep 23;230(3):696-705. doi: 10.1093/infdis/jiae211.
Individual participant dataSharing planned: Undecided

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

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.

Sharon A. Riddler, MD, MPH study chair

University of Pittsburgh

2 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 TAF/EVG Insert in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 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 16 inclusion and 30 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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 22 Dec 2023). 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?

Number of Participants With Grade 2 and Higher Adverse Events (AEs) (time frame: Measured from Enrollment through Final Contact at Visit 11 with a median (IQR) of 76 (47, 292) days. COVID restrictions delayed first dosing 9-10 months in 5 participants. Follow-up time from first dosing was a median (IQR) of 34 (22, 39) days.). The study lists 11 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 NCT04047420, 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 22 Dec 2023.