HIV PreventionPhase 1PREVENTNCT04032717
Griffithsin-based Rectal Microbicide for PREvention of Viral ENTry (PREVENT)
A Phase 1 study testing Q-Griffithsin (Q-GRFT) enema in people with HIV Prevention, run by Rhonda Brand at 1 site in United States.
Trial summary
This is the first-in-human clinical study to see if a single dose of an investigational enema made from a modified plant protein called Q-Griffithsin is safe, tolerated, and acceptable for use by healthy adults 18-45 years of age who practice receptive anal intercourse. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- Q-Griffithsin (Q-GRFT) enema
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2019to 4 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 18 through 45 years at screening, verified per site SOP
- Male participants, born male; female participants, born female.
- Availability to return for all study visits, barring unforeseen circumstances
- Willing and able to
- communicate in English
- provide written informed consent to take part in the study
Show all 31Show fewer
- provide adequate locator information, as defined in site SOP
- Must agree
- not to participate in other concurrent interventional and/or drug trials
- to use study-provided condoms for vaginal or anal intercourse for the duration of the study
- to avoid insertion of anything in the vagina or rectum (e.g., penis, sex toy, medication, enemas) 72 hours before and after study product exposure and rectal sampling visits
- Understands and agrees to local STI reporting requirements
- HIV-1 seronegative at screening and enrollment
- A history of RAI at least 5 times in lifetime and once in the prior year. (Required to assure that participants are comfortable with study procedures and study product administration.)
- Must be in general good health in the opinion of the investigator
- Using an effective method of contraception and intending to continue use of an effective method for the duration of study participation. Acceptable methods include:
- Males
- male condoms
- sterilization of participant or partner
- partner use of hormonal contraception or intrauterine device [IUD]
- identifies as a man who has sex with men exclusively
- and/or sexually abstinent for the past 90 days
- Females
- hormonal methods
- IUD inserted at least 28 days prior to enrollment
- sterilization of participant or partner
- and/or sexually abstinent for the past 90 days
- In addition to the criteria listed above, female participants must meet the following criteria:
- Not pregnant or breastfeeding
- Regular menstrual cycles of approximately 21 to 35 days apart with no untreated intermenstrual bleeding
- Note: This criterion is not applicable to participants using continuous combination oral contraceptive pills or progestin-only methods (such as Depo-Provera or levonorgestrel-releasing IUD), as the absence of regular menstrual cycles is an expected, normal consequence in this context.
Who cannot join
- Undergoing or completed gender reassignment
- Participant reports any of the following at Screening:
- Post-exposure prophylaxis for HIV exposure within 4 weeks prior to screening
- Condomless insertive or receptive anal intercourse with more than one partner in the past six months
- Known HIV-positive sexual partner within the last 6 months
- History of STI in the last 3 months
Show all 46Show fewer
- Transactional sex within the last 12 months
- Non-therapeutic injection drug use in the 12 months prior to screening
- Any use of methamphetamine, gamma hydroxybutyrate, cocaine or heroin in the 12 months prior to screening
- History of recurrent urticaria
- Use of antiretroviral medications with activity against HIV within the 4 weeks prior to the Enrollment, including PrEP with Truvada®
- Use of systemic immunomodulatory medications within the 4 weeks prior to the Enrollment
- Use of rectally administered medications or products (including condoms) containing Nonoxynol-9 (N-9) within the 4 weeks prior to the Enrollment
- Participating in another research study involving drugs or medical devices within the 4 weeks prior to the Enrollment
- Has plans to relocate away from the study site area during the period of study participation
- Per participant report at screening, anticipated use and/or unwillingness to abstain from the following medications during the period of study participation:
- Heparin, including Lovenox® (enoxaparin sodium)
- Warfarin
- Plavix® (clopidogrel bisulfate)
- Any other drugs that are associated with increased likelihood of bleeding following mucosal biopsy (e.g., daily high dose aspirin > than 81 mg, NSAIDs, or Pradaxa®)
- Rectally or vaginally administered medications (including over-the-counter products)
- Antiretroviral medications with activity against HIV
- History of significant gastrointestinal bleeding in the opinion of the investigator
- Abnormalities of the colorectal mucosa, or significant symptom(s), which in the opinion of the clinician represents a contraindication to protocol-required biopsies (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external hemorrhoids).
- At screening: participant-reported symptoms, and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current CDC guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include CT, GC, syphilis, active HSV lesions, chancroid, genital sores or ulcers, or symptomatic genital warts requiring treatment.
- Note:
- HSV-1 or HSV-2 seropositive diagnosis with no active lesions is allowed, since treatment is not required
- Has any of the following laboratory abnormalities at Screening:
- White blood cell count Grade 2 or higher
- Hemoglobin Grade 1 or higher
- Platelet count Grade 1 or higher
- International Normalized Ratio (INR) Grade 2 or higher
- Calculated creatinine clearance ≤ 70 mL/minute using the Cockcroft-Gault equation:
- ♀: (140 - age in yrs) x (weight in kg) x (0.85)/72 x (serum Cr in mg/dL)
- ♂: (140 - age in yrs) x (weight in kg) /72 x (serum Cr in mg/dL)
- Grade 2 or higher ALT and/or AST
- Grade 2 or higher Total bilirubin
- Positive for Hepatitis B surface antigen (HBsAg)
- Positive for Hepatitis C antibody (HCV Ab)
- Positive for HIV
- Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease
- In addition to the criteria listed above, female participants will be excluded if they meet any of the following criteria:
- Participant reports any of the following at Screening:
- Last pregnancy outcome or gynecological surgery 90 days or less prior to screening
- Intends to become pregnant during the period of study participation
- Chronic and/or recurrent symptomatic vaginal candidiasis
Trial locations and contacts
1 site in 1 country.
United States1 site
HIV/AIDS Clinical Research Unit / University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Randomized, Double-Blind Phase 1 Safety and Pharmacokinetic Study of Q-Griffithsin Enema Administered Rectally to HIV-1 Seronegative Adults
This is the first-in-human clinical study to see if a single dose of an investigational enema made from a modified plant protein called Q-Griffithsin is safe, tolerated, and acceptable for use by healthy adults 18-45 years of age who practice receptive anal intercourse.
Read the detailed description
A microbicide is a drug or agent designed to prevent transmission of HIV. Griffithsin, or "GRFT", is an investigational product that is being developed as a microbicide. GRFT is a naturally occurring protein originally isolated from the red alga Griffithsia found in the South Pacific Ocean. GRFT is one of the most powerful, broad-spectrum antivirals ever tested and its activity is under study for potential therapeutic applications against several viral pathogens including HIV, herpes simplex virus type-2, human papillomavirus (HPV), and hepatitis C. GRFT can be formulated into a number of delivery vehicles including gels, films, suppositories and even simple enemas or rinses.
The product is intended for use prior to sexual activity by people who practice receptive anal intercourse (RAI), and thus represent the population most vulnerable to HIV-1 transmission due to the high concentration of HIV target cells in the rectal mucosa and the presence of mucosal trauma commonly associated with RAI. For the purposes of this study GRFT has been genetically modified to produce a more stable compound less prone to oxidation, Q-GRFT.
Up to 21 HIV-uninfected individuals between the ages of 18 - 45 years will be enrolled in this study at the University of Pittsburgh, the only study site. Participants will be screened to exclude those with HIV infection, and anorectal sexually transmitted infections (STIs) (Visit 1). Up to 28 days after screening, eligible participants will return for a baseline visit (Visit 2), be assigned to a study arm, and undergo sample collection including flexible sigmoidoscopy with collection of colorectal biopsies.
The first 3 participants will be assigned to Arm 1 and receive a clinician administered single dose exposure of open-label Q-GRFT. Once the participants in Arm 1 complete Visit 4, study activity will be paused while the study Protocol Safety Review Team (PSRT) conducts an interim review of the clinical and laboratory data. In the absence of any significant safety concerns, the PSRT will be asked to approve enrollment of Study Arms 2 and 3. The remaining 18 participants will be assigned 2:1 in a randomized and blinded fashion to either Study Arm 2 (Q-GRFT) or 3 (placebo), respectively.
At Visit 3, participants will receive a clinician-administered single-dose exposure followed by flexible sigmoidoscopy with collection of colorectal biopsies at 1-hr and PK sampling of blood and rectal fluid at 1-hr and 4-hr. Participants will return to clinic the next day (Visit 4) for colorectal biopsies and 24-hr PK sampling. Participants in Arm 1 will additionally return for PK sampling including colorectal biopsies at 48 hrs (Visit 4a) following Visit 3. Participants will be contacted by study staff approximately 3 days after Visit 4 to collect safety information.
Participants will return for a final study visit, Visit 5, 4 weeks +/- 1 week after Visit 4/4a to collect blood samples for PK and immunogenicity assessments. A final study exit call for safety will occur within one week after the final study visit.
- Conditions
- HIV Prevention
- Being tested
- Q-Griffithsin (Q-GRFT) enema, Placebo enema
- Keywords
- microbicide, enema, receptive anal intercourse, HIV prevention, HIV transmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-Griffithsin (Q-GRFT) enemaDrug
Also called Study product enema
Investigational enema composed of 4.2mL Q-Griffithsin (Q-GRFT) 9.6mg/mL combined with approximately 120.8mL of 0.9% sodium chloride solution to yield an active enema study product that will contain and deliver a dose of approximately 40mg of Q-GRFT
Placebo enemaOther
Approximately 125mL of 0.9% sodium chloride solution
| Study group | Role | What they receive |
|---|---|---|
| Open-label Q-GRFT enema | Experimental | Open-label Q-GRFT enema administered rectally once as a single dose (Arm 1) Receives: Drug: Q-Griffithsin (Q-GRFT) enema |
| Randomized, blinded Q-GRFT enema | Experimental | Blinded Q-GRFT enema administered rectally once as a single dose (Arm 2) Receives: Drug: Q-Griffithsin (Q-GRFT) enema |
| Randomized, blinded placebo enema | Placebo comparator | Blinded placebo enema administered once as a single dose (Arm 3) Receives: Other: Placebo enema |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and frequency of adverse events Grade 2 or higher and genitourinary adverse events Grade 1 or higher
Safety analysis will be conducted on all participants who have receive study product. The number and the frequency of ≥ Grade 2 adverse events (AEs) and ≥ Grade 1 Genitourinary AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Version 2.1 (March 2017), Addendum 1 Female Genital Grading Table for Use in Microbicide Studies (November 2007), and/or Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification dated May 2012) to this table will be tabulated for each of the three methods of administration from Baseline through the final study contact. To determine whether AEs are occurring excessively, the proportion of subjects that experience an AE will be calculated for each method of administration. Additional safety analyses will also tabulate the number and type of AEs observed overall, and by severity, site, and study product. AEs that lead to discontinuation of study participation will be tabulated separately.
Measured: Baseline through the final study contact, or about 8 weeks
The proportion of participants who report product characteristics to be considered a barrier in study product use, operationalized as having a rating of lower than 3 on a 5-point Likert scale, in disliking or likelihood of future use
One day after study product administration, participants will complete an acceptability questionnaire to provide descriptive statistics on participants' opinions on the enema's characteristics, application process, the applicator design and the use-regimen, as well as the degree to which participants believe these characteristics and side-effects could pose barriers in future sustained use. On a 5-point Likert scale, with 1 being completely unacceptable and 5 being highly acceptable, the distributions of scores on all product characteristics will be examined to determine product characteristics that pose or could pose significant barriers in current or future product use.
Measured: Once 24 hours post-dose
Area under the concentration-time curve (AUC) of Q-GRFT
AUC of Q-GRFT as measured in plasma, rectal fluid, rectal mucosal tissue homogenates, and enema fluid effluent.
Measured: Pre-dose and 1, 4, and 24 hours post-dose
Maximum concentration (Cmax) of Q-GRFT
Cmax of Q-GRFT as measured in plasma, rectal fluid, rectal mucosal tissue homogenates, and enema fluid effluent.
Measured: Pre-dose and 1, 4, and 24 hours post-dose
Time to maximum concentration (Tmax) of Q-GRFT
Tmax of Q-GRFT as measured in plasma, rectal fluid, rectal mucosal tissue homogenates, and enema fluid effluent .
Measured: Pre-dose and 1, 4, and 24 hours post-dose
Minimum concentration (Cmin) of Q-GRFT
Cmin of Q-GRFT as measured in plasma, rectal fluid, rectal mucosal tissue homogenates, and enema fluid effluent.
Measured: Pre-dose and 1, 4, and 24 hours post-dose
Half-life (t½) of Q-GRFT
t½ of Q-GRFT as measured in plasma, rectal fluid, rectal mucosal tissue homogenates, and enema fluid effluent.
Measured: Pre-dose and 1, 4, and 24 hours post-dose
Secondary outcomes (1)
Change in humoral antibody responses to Q-GRFT in blood by ELISA and PBMC Q-GRFT antigen stimulation
The titer of immunoglobulins in blood and rectal secretions will be assessed. Lymphocytes collected from peripheral blood will be stimulated with Q-GRFT and an ELISPot assay used to quantify number of B-cells that produce specific antibodies.
Measured: Baseline and 4 weeks post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2019
- Study start10 Jul 2019
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Why it stopped: Due to the COVID-19 pandemic, study enrollment has been prematurely terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhonda Brand
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Intrucept Biomedicine LLC
- Responsible party
- Sponsor-investigator, Rhonda Brand, University of Pittsburgh
- Investigators
- Ken Ho, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04032717
- Sponsor's protocol ID
- STUDY19030322
- Other IDs
- U19AI113182
- Acronym
- PREVENT
- Status last verified
- Jul 2023
- First submitted
- 2 Apr 2019
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The awardee institution will follow Federal grant policies concerning the sharing of research data. The awardee institution will share its information, data and resources among its own researchers and the collaborating researchers as well as with researchers at other institutions. The research team will make the results of this collaboration and any accompanying data available to the public. In accordance with Federal policies on Data Sharing, research data will be made available to researchers and/or the general public as requested. The limitations on this policy are that data will not generally be available until such a time that it is submitted for publication. Also, all human subjects' rights to privacy with respect to any human tissue samples to be used as a part of this study will be approved by the appropriate regulatory boards, protected and de-identified.
Publications
Shrivastava-Ranjan P, Lo MK, Chatterjee P, Flint M, Nichol ST, Montgomery JM, O'Keefe BR, Spiropoulou CF. Hantavirus Infection Is Inhibited by Griffithsin in Cell Culture. Front Cell Infect Microbiol. 2020 Nov 4;10:561502. doi: 10.3389/fcimb.2020.561502. eCollection 2020.
PubMed 33251157
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Phase 1 Safety and Pharmacokinetic Study of Q-Griffithsin Enema Administered Rectally to HIV-1 Seronegative Adults
- ClinicalTrials.gov ID
- NCT04032717
- Acronym / sponsor ID
- PREVENT / STUDY19030322
- Conditions
- HIV Prevention
- Keywords
- microbicide, enema, receptive anal intercourse, HIV prevention, HIV transmission
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the COVID-19 pandemic, study enrollment has been prematurely terminated.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rhonda BrandUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Intrucept Biomedicine LLC
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 25 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is the first-in-human clinical study to see if a single dose of an investigational enema made from a modified plant protein called Q-Griffithsin is safe, tolerated, and acceptable for use by healthy adults 18-45 years of age who practice receptive anal intercourse.
Detailed description
A microbicide is a drug or agent designed to prevent transmission of HIV. Griffithsin, or "GRFT", is an investigational product that is being developed as a microbicide. GRFT is a naturally occurring protein originally isolated from the red alga Griffithsia found in the South Pacific Ocean. GRFT is one of the most powerful, broad-spectrum antivirals ever tested and its activity is under study for potential therapeutic applications against several viral pathogens including HIV, herpes simplex virus type-2, human papillomavirus (HPV), and hepatitis C. GRFT can be formulated into a number of delivery vehicles including gels, films, suppositories and even simple enemas or rinses.
The product is intended for use prior to sexual activity by people who practice receptive anal intercourse (RAI), and thus represent the population most vulnerable to HIV-1 transmission due to the high concentration of HIV target cells in the rectal mucosa and the presence of mucosal trauma commonly associated with RAI. For the purposes of this study GRFT has been genetically modified to produce a more stable compound less prone to oxidation, Q-GRFT.
Up to 21 HIV-uninfected individuals between the ages of 18 - 45 years will be enrolled in this study at the University of Pittsburgh, the only study site. Participants will be screened to exclude those with HIV infection, and anorectal sexually transmitted infections (STIs) (Visit 1). Up to 28 days after screening, eligible participants will return for a baseline visit (Visit 2), be assigned to a study arm, and undergo sample collection including flexible sigmoidoscopy with collection of colorectal biopsies.
The first 3 participants will be assigned to Arm 1 and receive a clinician administered single dose exposure of open-label Q-GRFT. Once the participants in Arm 1 complete Visit 4, study activity will be paused while the study Protocol Safety Review Team (PSRT) conducts an interim review of the clinical and laboratory data. In the absence of any significant safety concerns, the PSRT will be asked to approve enrollment of Study Arms 2 and 3. The remaining 18 participants will be assigned 2:1 in a randomized and blinded fashion to either Study Arm 2 (Q-GRFT) or 3 (placebo), respectively.
At Visit 3, participants will receive a clinician-administered single-dose exposure followed by flexible sigmoidoscopy with collection of colorectal biopsies at 1-hr and PK sampling of blood and rectal fluid at 1-hr and 4-hr. Participants will return to clinic the next day (Visit 4) for colorectal biopsies and 24-hr PK sampling. Participants in Arm 1 will additionally return for PK sampling including colorectal biopsies at 48 hrs (Visit 4a) following Visit 3. Participants will be contacted by study staff approximately 3 days after Visit 4 to collect safety information.
Participants will return for a final study visit, Visit 5, 4 weeks +/- 1 week after Visit 4/4a to collect blood samples for PK and immunogenicity assessments. A final study exit call for safety will occur within one week after the final study visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, double-blind
| Arm | Type | Receives |
|---|---|---|
| Open-label Q-GRFT enema | Experimental | Drug: Q-Griffithsin (Q-GRFT) enemaOpen-label Q-GRFT enema administered rectally once as a single dose (Arm 1) |
| Randomized, blinded Q-GRFT enema | Experimental | Drug: Q-Griffithsin (Q-GRFT) enemaBlinded Q-GRFT enema administered rectally once as a single dose (Arm 2) |
| Randomized, blinded placebo enema | Placebo comparator | Other: Placebo enemaBlinded placebo enema administered once as a single dose (Arm 3) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (31 listed)
- Age of 18 through 45 years at screening, verified per site SOP
- Male participants, born male; female participants, born female.
- Availability to return for all study visits, barring unforeseen circumstances
- Willing and able to
- Must agree
Key exclusion criteria (46 listed)
- Undergoing or completed gender reassignment
- Participant reports any of the following at Screening:
- Per participant report at screening, anticipated use and/or unwillingness to abstain from the following medications during the period of study participation:
- History of significant gastrointestinal bleeding in the opinion of the investigator
- Abnormalities of the colorectal mucosa, or significant symptom(s), which in the opinion of the clinician represents a contraindication to protocol-required biopsies (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external hemorrhoids).
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 |
|---|---|---|
| Q-Griffithsin (Q-GRFT) enemaAlso: Study product enemaInvestigational enema composed of 4.2mL Q-Griffithsin (Q-GRFT) 9.6mg/mL combined with approximately 120.8mL of 0.9% sodium chloride solution to yield an active enema study product that will contain and deliver a dose of approximately 40mg of Q-GRFT | Drug | Open-label Q-GRFT enema, Randomized, blinded Q-GRFT enema |
| Placebo enemaApproximately 125mL of 0.9% sodium chloride solution | Other | Randomized, blinded placebo enema |
Primary outcome
The number and frequency of adverse events Grade 2 or higher and genitourinary adverse events Grade 1 or higher
Time frame: Baseline through the final study contact, or about 8 weeks
Safety analysis will be conducted on all participants who have receive study product. The number and the frequency of ≥ Grade 2 adverse events (AEs) and ≥ Grade 1 Genitourinary AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric AEs, Version 2.1 (March 2017), Addendum 1 Female Genital Grading Table for Use in Microbicide Studies (November 2007), and/or Addendum 3 Rectal Grading Table for Use in Microbicide Studies (Clarification dated May 2012) to this table will be tabulated for each of the three methods of administration from Baseline through the final study contact. To determine whether AEs are occurring excessively, the proportion of subjects that experience an AE will be calculated for each method of administration. Additional safety analyses will also tabulate the number and type of AEs observed overall, and by severity, site, and study product. AEs that lead to discontinuation of study participation will be tabulated separately.
The proportion of participants who report product characteristics to be considered a barrier in study product use, operationalized as having a rating of lower than 3 on a 5-point Likert scale, in disliking or likelihood of future use
Time frame: Once 24 hours post-dose
One day after study product administration, participants will complete an acceptability questionnaire to provide descriptive statistics on participants' opinions on the enema's characteristics, application process, the applicator design and the use-regimen, as well as the degree to which participants believe these characteristics and side-effects could pose barriers in future sustained use. On a 5-point Likert scale, with 1 being completely unacceptable and 5 being highly acceptable, the distributions of scores on all product characteristics will be examined to determine product characteristics that pose or could pose significant barriers in current or future product use.
Area under the concentration-time curve (AUC) of Q-GRFT
Time frame: Pre-dose and 1, 4, and 24 hours post-dose
AUC of Q-GRFT as measured in plasma, rectal fluid, rectal mucosal tissue homogenates, and enema fluid effluent.
Maximum concentration (Cmax) of Q-GRFT
Time frame: Pre-dose and 1, 4, and 24 hours post-dose
Cmax of Q-GRFT as measured in plasma, rectal fluid, rectal mucosal tissue homogenates, and enema fluid effluent.
Time to maximum concentration (Tmax) of Q-GRFT
Time frame: Pre-dose and 1, 4, and 24 hours post-dose
Tmax of Q-GRFT as measured in plasma, rectal fluid, rectal mucosal tissue homogenates, and enema fluid effluent .
Minimum concentration (Cmin) of Q-GRFT
Time frame: Pre-dose and 1, 4, and 24 hours post-dose
Cmin of Q-GRFT as measured in plasma, rectal fluid, rectal mucosal tissue homogenates, and enema fluid effluent.
Half-life (t½) of Q-GRFT
Time frame: Pre-dose and 1, 4, and 24 hours post-dose
t½ of Q-GRFT as measured in plasma, rectal fluid, rectal mucosal tissue homogenates, and enema fluid effluent.
1 secondary outcome
Change in humoral antibody responses to Q-GRFT in blood by ELISA and PBMC Q-GRFT antigen stimulation
Time frame: Baseline and 4 weeks post-dose
Results and safety
The study was stopped early (reason given: Due to the COVID-19 pandemic, study enrollment has been prematurely terminated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Derived from this study: PubMed 33251157Shrivastava-Ranjan P, Lo MK, Chatterjee P, Flint M, Nichol ST, Montgomery JM, O'Keefe BR, Spiropoulou CF. Hantavirus Infection Is Inhibited by Griffithsin in Cell Culture. Front Cell Infect Microbiol. 2020 Nov 4;10:561502. doi: 10.3389/fcimb.2020.561502. eCollection 2020.
- Individual participant dataSharing planned: Yes. The awardee institution will follow Federal grant policies concerning the sharing of research data. The awardee institution will share its information, data and resources among its own researchers and the collaborating researchers as well as with researchers at other institutions. The research team will make the results of this collaboration and any accompanying data available to the public. In accordance with Federal policies on Data Sharing, research data will be made available to researchers and/or the general public as requested. The limitations on this policy are that data will not generally be available until such a time that it is submitted for publication. Also, all human subjects' rights to privacy with respect to any human tissue samples to be used as a part of this study will be approved by the appropriate regulatory boards, protected and de-identified.
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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.
Ken Ho, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Q-Griffithsin (Q-GRFT) enema in people with HIV Prevention, run by Rhonda Brand at 1 site 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 31 inclusion and 46 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: stopped early, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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. 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?
The study was stopped early (reason given: Due to the COVID-19 pandemic, study enrollment has been prematurely terminated.). Results are not available in the source record.
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?
The number and frequency of adverse events Grade 2 or higher and genitourinary adverse events Grade 1 or higher (time frame: Baseline through the final study contact, or about 8 weeks). The study lists 7 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 NCT04032717, 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 6 Jul 2023.