HIV InfectionsPhase 1NCT03408899

Evaluating the Safety and Pharmacokinetics of PC-1005 Administered Rectally to HIV-1 Seronegative Adults

A Phase 1 study testing PC-1005 gel 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 PC-1005 gel when used as a rectal microbicide in HIV-uninfected men and women (cis or transgender) with a history of consensual receptive anal intercourse. 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?: PC-1005 gel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 2 sitesUnited States
Study dates: 19 Jun 2018to 19 Apr 2019
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

Men and women (cis or transgender) who are 18 years or older 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 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

At Screening, history of consensual receptive anal intercourse (RAI) at least once in their lifetime per participant report
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 follow abstinence requirements for the duration of study participation (See the protocol for additional information)
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 and intending to use an effective method for the duration of study participation; these include:
Hormonal methods, excluding vaginal rings
Intrauterine device (IUD) inserted at least 42 days prior to Enrollment (but not past the maximum length of recommended usage according to package instructions)
Sterilization of participant or partner at least 42 days prior to Enrollment
Self-identifies as having sex with women exclusively

Who cannot join

At Screening:
Hemoglobin Grade 1 or higher*
Platelet count Grade 1 or higher*
White blood count Grade 2 or higher*
Aspartate aminotransferase (AST) or alanine transaminase (ALT) Grade 1 or higher*
Serum creatinine greater than 1.3x the site laboratory upper limit of normal (ULN)

Show all 32Show fewer

International normalized ratio (INR) greater than 1.5x the site laboratory ULN
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 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.
Known adverse reaction to latex or polyurethane (ever)
Anticipated use of and/or unwillingness to abstain from the following medications during study participation:
Anticoagulant medications
Rectally-administered medications
Known adverse reaction to any of the components of the study product
Use of pre-exposure prophylaxis (PrEP) for HIV prevention within 1 month 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 the 3 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
Non-therapeutic injection drug use 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
Gynecologic, genital, or rectal procedure (e.g., tubal ligation, dilation and curettage, piercing, hemorrhoidal resection, polyp removal) 60 days or less prior to Enrollment, or rectal biopsy, 7 days or less prior to Enrollment. Note: Colposcopy and cervical biopsies for evaluation of an abnormal Pap test as well as IUD insertion/removal are not exclusionary. Anoscopy and endoscopy without rectal biopsies are not exclusionary
Per participant report, medical records, clinical diagnosis and/or diagnostic testing at either Screening or Enrollment:
Diagnosis or treatment of any anogenital sexually transmitted infection (STI) in the past 3 months (including window between Screening and Enrollment)
Symptoms, clinical or laboratory diagnosis of active pharyngeal, anorectal infection 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, anogenital sores or ulcers, or symptomatic genital warts, chancroid, pelvic inflammatory disease (PID), symptomatic bacterial vaginosis (BV), symptomatic vaginal candidiasis, other vaginitis, and trichomoniasis.
Note: Otherwise eligible participants with an exclusionary UTI, BV and/or candida finding may be re-tested during the screening process.
Note: HSV-1 or HSV-2 seropositive diagnosis with no active lesions is permitted since treatment is not required.
Participants who meet any of the following additional criteria will be excluded from the study:
Pregnant or breastfeeding at either Screening or Enrollment or planning to become pregnant or begin 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 any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.

Trial locations and contacts

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 Safety and Pharmacokinetic Study of PC-1005 (MIV-150/Zinc Acetate/Carrageenan Gel) Administered Rectally to HIV-1 Seronegative Adults

Read the detailed description

PC-1005 is a multipurpose prevention technology (MPT) microbicide in development that is active against HIV, HPV, and HSV-2. This study will evaluate the safety and pharmacokinetics of PC-1005 gel when administered rectally.

The study will enroll HIV-uninfected men and women (cis or transgender) with a history of consensual receptive anal intercourse. All participants will receive 3 single escalating doses of rectally administered PC-1005: 4 mL, 16 mL and 32 mL.

The study includes a total of 9 clinic visits and 1 follow-up contact by phone or in person. Participants will receive doses of PC-1005 at Visits 3, 5, and 7. A 2-to-6 week washout period will follow each dosing visit. If no adverse events that preclude continuation to the next dose are identified during this period, participants will receive the next scheduled dose of PC-1005. Participation in this study will last approximately 3 to 5 months.

Study visits will include physical examinations, throat swabs, behavioral assessments and interviews, and collection of blood, urine, rectal tissue, and cervical, vaginal, and rectal fluid.

Conditions: HIV Infections
Being tested: PC-1005 gel
Keywords: Microbicides
Medical subject headings: HIV Infections

What participants receive

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

PC-1005 gelDrug
PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL, 16 mL, and 32 mL doses administered rectally.

Study groups in NCT03408899
Study group	Role	What they receive
PC-1005	Experimental	All participants will receive 3 single escalating doses of PC-1005 gel during Visits 3, 5, and 7, with a 2-to-6-week washout period between dosing visits. Each participant will be on study for approximately 3 to 5 months. Receives: Drug: PC-1005 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)
AEs are 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 through participants' last study visit which will occur at Month 3 to 5, depending on the participant
MIV-150 Concentrations in Plasma
Descriptive statistics such as the mean and median and corresponding 95% confidence intervals will be used to describe the MIV-150 concentrations in all biological matrices assessed at all scheduled time points
Measured: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant
MIV-150 Concentrations in Rectal Fluid
Descriptive statistics such as the mean and median and corresponding 95% confidence intervals will be used to describe the MIV-150 concentrations in all biological matrices assessed at all scheduled time points
Measured: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant
MIV-150 Concentrations in Rectal Mucosal Tissue Homogenates
Descriptive statistics such as the mean and median and corresponding 95% confidence intervals will be used to describe the MIV-150 concentrations in all biological matrices assessed at all scheduled time points
Measured: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

Secondary outcomes (5)

Participant Self-report Gel Acceptability - Ease of Use
Response for "Overall, how easy or difficult was it to use the gel when applied by clinic staff?" at exit self-interview questionnaire.
Measured: Through study completion, approximately 3-5 months for each participant
Participant Self-report Gel Acceptability - Feeling When Inserted
Response for "Overall, how did it feel to have the gel inside you?" at exit self-interview questionnaire.
Measured: Through study completion, approximately 3-5 months for each participant
Participant Self-report Gel Acceptability - Problems With Gel Use
Responses for questions related to problem with gel use at exit self-interview questionnaire
Measured: Through study completion, approximately 3-5 months for each participant
Participant Self-report Gel Acceptability - Gel Acceptability
Response for questions related to gel acceptability at exit self-interview questionnaire.
Measured: Through study completion, approximately 3-5 months for each participant
MIV-150 Concentrations in Vaginal Fluid
Descriptive statistics such as the mean and median and corresponding 95% confidence intervals will be used to describe the MIV-150 concentrations in all biological matrices assessed at all scheduled time points
Measured: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

Timeline

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

19 Jun 201819 Apr 2019

First posted24 Jan 2018
Study start19 Jun 2018
Primary completion19 Apr 2019
Study completion19 Apr 2019

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: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03408899
Sponsor's protocol ID: MTN-037
Other IDs: 35122
Status last verified: Apr 2023
First submitted: 18 Jan 2018
Last updated: 14 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Ho K, Hoesley C, Anderson PL, Fernandez-Romero JA, Friedland BA, Kelly CW, Jiao Y, Edick S, Brand R, Kunjara Na Ayudhya RP, Zyhowski A, Hartman DJ, Reddy NB, Al-Khouja A, Piper J, Bauermeister JA, Teleshova N, Melo C, Cornejal N, Barnable P, Singh D, Scheckter R, McClure T, Hillier SL, Hendrix CW; MTN-037 Study Team. Phase I Dose Volume Escalation of Rectally Administered PC-1005 to Assess Safety, Pharmacokinetics, and Antiviral Pharmacodynamics as a Multipurpose Prevention Technology (MTN-037). J Acquir Immune Defic Syndr. 2024 Dec 1;97(4):379-386. doi: 10.1097/QAI.0000000000003506.
PubMed 39808074

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 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Safety and Pharmacokinetic Study of PC-1005 (MIV-150/Zinc Acetate/Carrageenan Gel) Administered Rectally to HIV-1 Seronegative Adults
ClinicalTrials.gov ID: NCT03408899
Acronym / sponsor ID: MTN-037
Conditions: HIV Infections
Keywords: Microbicides
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 19 Jun 2018 (actual)
Primary completion: 19 Apr 2019 (actual)
Study completion: 19 Apr 2019 (actual)
First posted: 24 Jan 2018 (actual)
Results: Posted 14 Apr 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

Study visits will include physical examinations, throat swabs, behavioral assessments and interviews, and collection of blood, urine, rectal tissue, and cervical, vaginal, and rectal fluid.

Study design

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

Arm	Type	Receives
PC-1005	Experimental	Drug: PC-1005 gelAll participants will receive 3 single escalating doses of PC-1005 gel during Visits 3, 5, and 7, with a 2-to-6-week washout period between dosing visits. Each participant will be on study for approximately 3 to 5 months.

Who may qualify

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

Key inclusion criteria (15 listed)

Men and women (cis or transgender) who are 18 years or older 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 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 (32 listed)

At Screening:
Known adverse reaction to latex or polyurethane (ever)
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 pre-exposure prophylaxis (PrEP) for HIV prevention within 1 month prior to Enrollment, and/or anticipated use and/or unwillingness to abstain from PrEP 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
PC-1005 gelPC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL, 16 mL, and 32 mL doses administered rectally.	Drug	PC-1005

Primary outcome

Frequency of Grade 2 or Higher Adverse Events (AEs)
Time frame: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant
AEs are 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).
MIV-150 Concentrations in Plasma
Time frame: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant
Descriptive statistics such as the mean and median and corresponding 95% confidence intervals will be used to describe the MIV-150 concentrations in all biological matrices assessed at all scheduled time points
MIV-150 Concentrations in Rectal Fluid
Time frame: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant
Descriptive statistics such as the mean and median and corresponding 95% confidence intervals will be used to describe the MIV-150 concentrations in all biological matrices assessed at all scheduled time points
MIV-150 Concentrations in Rectal Mucosal Tissue Homogenates
Time frame: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant
Descriptive statistics such as the mean and median and corresponding 95% confidence intervals will be used to describe the MIV-150 concentrations in all biological matrices assessed at all scheduled time points

5 secondary outcomes

Participant Self-report Gel Acceptability - Ease of Use
Time frame: Through study completion, approximately 3-5 months for each participant
Participant Self-report Gel Acceptability - Feeling When Inserted
Time frame: Through study completion, approximately 3-5 months for each participant
Participant Self-report Gel Acceptability - Problems With Gel Use
Time frame: Through study completion, approximately 3-5 months for each participant
Participant Self-report Gel Acceptability - Gel Acceptability
Time frame: Through study completion, approximately 3-5 months for each participant
MIV-150 Concentrations in Vaginal Fluid
Time frame: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant

Results and safety

Results posted to the registry on 14 Apr 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
All Enrolled Participants	13	12

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

Time frame: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant. Count of participants. Unit: Participants

Measure	4 mL n = 13	16 mL n = 12	32 mL n = 12
Value	1	2	0

Primary outcome: MIV-150 Concentrations in Plasma

Time frame: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant. Median (Inter-Quartile Range). Unit: pg/mL

Measure	4 mL n = 13	16 mL n = 12	32 mL n = 12
Predosing	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
1 hour postdosing	74.0 (52.0 to 86.0)	164.0 (87.0 to 187.0)	158.5 (110.0 to 267.5)
2 hours postdosing	66.5 (45.0 to 83.5)	183.5 (162.0 to 211.0)	171.0 (98.0 to 316.0)
3 hours postdosing	37.0 (23.0 to 54.0)	134.0 (84.0 to 191.5)	143.0 (66.0 to 172.5)
4 hours postdosing	24.0 (13.0 to 48.0)	86.5 (63.0 to 143.5)	105.0 (40.0 to 138.5)
5-6 hours postdosing	13.0 (11.0 to 28.0)	57.0 (42.5 to 88.0)	63.5 (25.0 to 121.0)
24 hours postdosing	0 (0 to 0)	0 (0 to 0)	0 (0 to 22.0)
48 hours postdosing	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

Population analysed: Participants are randomly assigned 1:1:1 to provide samples of rectal fluid 48 hours after one of the three dose administrations. One participant missed 2 hour postdosing plasma sample collection at 4mL dosing visit. One participant missed 1 hour postdosing plasma sample collection at 16mL dosing visit. One participant missed 24 hour postdosing plasma sample collection at 32mL dosing visit.

Primary outcome: MIV-150 Concentrations in Rectal Fluid

Time frame: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant. Median (Inter-Quartile Range). Unit: ng/mL

Measure	4 mL n = 13	16 mL n = 12	32 mL n = 12
0.5-1 hour postdosing	122.0 (13.2 to 11464.0)	135.0 (20.2 to 3691.0)	104.0 (72.8 to 7854.0)
1.5-3 hour postdosing	19.3 (14.1 to 41.9)	23.2 (10.8 to 420.0)	4582.0 (116.0 to 7272.0)
3.5-5 hour postdosing	19.6 (7.8 to 66.7)	14.9 (3.1 to 37.0)	39.7 (4.8 to 419.0)
24 hour postdosing	0 (0 to 0)	5.9 (2.5 to 6.8)	0 (0 to 131.0)
48 hour postdosing	0 (0 to 0)	0 (0 to 16.9)	0 (0 to 0)

Population analysed: Participants are randomized 1:1:1:1 to provide samples of rectal fluid in one of the following time periods after dose administration : 0.5-1 hour; 1.5-3 hours; 3.5-5 hours, or 24 hours. Participants are randomly assigned 1:1:1 to provide samples of rectal fluid 48 hours after one of the three dose administrations.

Primary outcome: MIV-150 Concentrations in Rectal Mucosal Tissue Homogenates

Time frame: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant. Median (Inter-Quartile Range). Unit: ng/mL

Measure	4 mL n = 13	16 mL n = 12	32 mL n = 12
0.5-1 hour postdosing	1.4 (0.8 to 1.9)	46.0 (30.7 to 831.0)	79.7 (11.9 to 116.0)
1.5-3 hour postdosing	0 (0 to 3.6)	12.7 (4.8 to 313.0)	35.8 (2.5 to 186.0)
3.5-5 hour postdosing	0 (0 to 0.9)	4.8 (0 to 6.5)	0 (0 to 0)
24 hour postdosing	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)
48 hour postdosing	0 (0 to 0)	0 (0 to 0)	0 (0 to 0)

Population analysed: Three participants are randomized to provide rectal tissue sample in one of the following time periods after dose administration : 0.5-1 hour; 1.5-3 hours; 3.5-5 hours, or 24 hours. Four participants are randomized to provide rectal tissue sample 48 hours after each of the three dose administrations. Two participants had late sample at 4mL dose.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From 4mL dose administration date to end of the study, approximately 3-5 months for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
4 mL	0 of 13 (0%)	3 of 13 (23.1%)	0 of 13
16 mL	0 of 12 (0%)	3 of 12 (25%)	0 of 12
32 mL	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39808074Ho K, Hoesley C, Anderson PL, Fernandez-Romero JA, Friedland BA, Kelly CW, Jiao Y, Edick S, Brand R, Kunjara Na Ayudhya RP, Zyhowski A, Hartman DJ, Reddy NB, Al-Khouja A, Piper J, Bauermeister JA, Teleshova N, Melo C, Cornejal N, Barnable P, Singh D, Scheckter R, McClure T, Hillier SL, Hendrix CW; MTN-037 Study Team. Phase I Dose Volume Escalation of Rectally Administered PC-1005 to Assess Safety, Pharmacokinetics, and Antiviral Pharmacodynamics as a Multipurpose Prevention Technology (MTN-037). J Acquir Immune Defic Syndr. 2024 Dec 1;97(4):379-386. doi: 10.1097/QAI.0000000000003506.

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.

Craig Hendrix, MD study chair

Johns Hopkins University

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 PC-1005 gel 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 15 inclusion and 32 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 14 Apr 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 14 Apr 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?

Frequency of Grade 2 or Higher Adverse Events (AEs) (time frame: Measured through participants' last study visit which will occur at Month 3 to 5, depending on the participant). The study lists 4 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 NCT03408899, 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 14 Apr 2023.