HIV InfectionPhase 1NCT02875119
Study to Evaluate the Safety of Griffithsin in a Carrageenan Gel in Healthy Women
A Phase 1 study testing Griffithsin Gel in people with HIV Infection, run by Population Council at 1 site in United States.
Trial summary
This is a two-part study. The first part is a single-dose open label design. The second part employs a multiple dose, randomized, placebo controlled study design. Studies have demonstrated that GRFT is highly potent for HIV prevention and is effective at very low concentrations. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Griffithsin Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 1 Sep 2018
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1) Between 18 and 49 years of age (at screening), inclusive.
- 2) Willing and able to provide written informed consent.
- 3) Healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections and laboratory evaluations for hematology, liver and renal function.
- 4) HIV-negative as determined by HIV ELISA test at screening.
- 5) In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days between menses.
- 6) Normal Pap test at screening. (Documentation of normal Pap test results within 12 months prior to screening is also acceptable.)
Show all 9Show fewer
- 7) Agrees to use effective contraception for the duration of the trial. If hormonal contraception or intrauterine device (IUD)/ Intrauterine system (IUS) is being used, it must be have been used for at least 30 days prior to screening, with no planned change in method during the study. The following forms of contraception (per self-report) are permitted: same-sex relationship, male or female sterilization, oral contraceptives, contraceptive implant, contraceptive patch, IUS, IUD depo-medroxyprogesterone acetate (DMPA; Depo-Provera®).
- 8) Willing to abstain from sexual intercourse/activity including receptive vaginal, oral, digital, and anal intercourse, and the use of any vaginal products including tampons, male and female condoms, contraceptive sponges, diaphragms, cervical caps, douches, lubricants, and vibrators/dildos; starting the Screening Visit (Visit 0) through the final safety visit (Visit 3/Day 8) in the OL period; and starting 48 hours before enrollment through the final safety visit (Visit 8/Day 21) in the randomized period
- 9) Agrees to not participate in any other clinical research for the duration of this trial.
Who cannot join
- 1) History of or known sensitivity/allergy to any component of either study product.
- 2) Currently pregnant or breast-feeding, or within 3 months of last pregnancy outcome.
- 3) Participation in any other clinical research trial involving investigational or marketed products currently or within two months of participation prior to screening, including any trial of a spermicide, microbicide and/or drug.
- 4) Known bleeding disorder that could lead to prolonged or continuous bleeding with biopsy.
- 5) Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 3 months. Note: Women with a history of condylomata or genital herpes who have been asymptomatic for at least six months may be considered for eligibility.
- 6) Positive test for Neisseria gonorrhea (NG), Chlamydia trachomatis (CT), or Trichomonas vaginalis (TV) at screening.
Show all 16Show fewer
- 7) Symptomatic vulvovaginal candidiasis, bacterial vaginosis (BV), or urinary tract infection (UTI) at screening. (Participants who test positive at initial screening may be treated and re-tested once, and reconsidered for screening).
- 8) Presence of any clinically significant genital epithelial findings (e.g. abrasions, ulcerations, or lacerations, or vesicles) suspicious for STIs at screening.
- 9) History of hysterectomy or menopause.
- 10) Use of excluded contraceptive methods including Nuvaring®, condoms (male or female), contraceptive sponge, diaphragm, or cervical cap.
- 11) History of gynecological surgery or procedure within past 2 months.
- 12) History of uterine prolapse, undiagnosed vaginal bleeding or urethral obstruction within the last 3 months, including unexplained break-through bleeding requiring sanitary protection.
- 13) Known current drug abuse, including illicit drugs, or alcohol abuse.
- 14) Abnormal finding on laboratory or physical examination or a social or medical condition which, in the opinion of the investigator, would make participation in the study unsafe or would complicate interpretation of data.
- 15) Unable to comply with study requirements, including but not limited to, attending all study visits, using the gel as directed, observing abstinence throughout the study and use of allowable effective contraceptives.
- 16) History of latex allergy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: A Phase 1 Trial to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PC-6500 (Griffithsin [GRFT] in a Carrageenan Gel) in Healthy Women
This is a two-part study. The first part is a single-dose open label design. The second part employs a multiple dose, randomized, placebo controlled study design. Studies have demonstrated that GRFT is highly potent for HIV prevention and is effective at very low concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal concentration of GRFT for the prevention of HIV, based on preclinical data, will be evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be minimally absorbed systemically, if at all.
- Conditions
- HIV Infection
- Being tested
- Griffithsin Gel, Placebo Gel
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Griffithsin GelDrug
Griffithsin Gel is a large biologic molecule that is intended for vaginal rather than systemic administration. In addition, Griffithsin Gel is being developed for the prevention of HIV infection and not as a therapeutic agent. The concentration of Griffithsin Gel associated with prevention of HIV in vitro and in vivo has been established in non-clinical studies (see Section 5). Studies have demonstrated that Griffithsin Gel is highly potent for HIV prevention and is effective at very low concentrations.
One 4 mL dose of PC-6500, designed to provide an adequate vaginal concentration of GRFT for the prevention of HIV, based on preclinical data, will be evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be minimally absorbed systemically, if at all.
Placebo GelDrug
Placebo Gel
| Study group | Role | What they receive |
|---|---|---|
| Griffithsin Gel | Experimental | In the randomized period, duration of treatment will be 14 days; each of the 30 subjects will self-administer Griffithsin Gel once daily for 14 consecutive days, with 5 doses administered under clinical supervision and the remaining 9 doses administered at home. Receives: Drug: Griffithsin Gel |
| Placebo Gel | Placebo comparator | In the randomized period, duration of treatment will be 14 days; each of the 30 subjects will self-administer placebo gel once daily for 14 consecutive days, with 5 doses administered under clinical supervision and the remaining 9 doses administered at home. Receives: Drug: Placebo Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percent of participants with TEAEs, SAEs and AEs leading to premature discontinuation.
To evaluate the safety of PC-6500 gel used vaginally for a single dose; and then for 14 consecutive days of dosing. AEs will be coded in accordance with the current version of the Medical Dictionary for Regulatory Activities (MedDRA).
Measured: 10 months
Secondary outcomes (1)
Evaluation of the area under the time-concentration curve of Griffithsin gel in blood during and after dosing as assessed by (AUC0-last; AUC0-∞)
To determine the PK of Griffithsin Gel in blood after a single dose, and then after 14 days of dosing.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start1 Oct 2017
- Primary completion31 Jul 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Council
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Creasy, MD, Study chair, Population Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875119
- Sponsor's protocol ID
- 728
- Status last verified
- Nov 2018
- First submitted
- 15 Aug 2016
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Teleshova N, Keller MJ, Fernandez Romero JA, Friedland BA, Creasy GW, Plagianos MG, Ray L, Barnable P, Kizima L, Rodriguez A, Cornejal N, Melo C, Cruz Rodriguez G, Mukhopadhyay S, Calenda G, Sinkar SU, Bonnaire T, Wesenberg A, Zhang S, Kleinbeck K, Palmer K, Alami M, O'Keefe BR, Gillevet P, Hur H, Liang Y, Santone G, Fichorova RN, Kalir T, Zydowsky TM. Results of a phase 1, randomized, placebo-controlled first-in-human trial of griffithsin formulated in a carrageenan vaginal gel. PLoS One. 2022 Jan 20;17(1):e0261775. doi: 10.1371/journal.pone.0261775. eCollection 2022.
PubMed 35051209Shrivastava-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 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial to Evaluate the Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PC-6500 (Griffithsin [GRFT] in a Carrageenan Gel) in Healthy Women
- ClinicalTrials.gov ID
- NCT02875119
- Acronym / sponsor ID
- 728
- Conditions
- HIV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Population CouncilUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 23 Aug 2016 (estimated)
- 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 a two-part study. The first part is a single-dose open label design. The second part employs a multiple dose, randomized, placebo controlled study design. Studies have demonstrated that GRFT is highly potent for HIV prevention and is effective at very low concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal concentration of GRFT for the prevention of HIV, based on preclinical data, will be evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be minimally absorbed systemically, if at all.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Griffithsin Gel | Experimental | Drug: Griffithsin GelIn the randomized period, duration of treatment will be 14 days; each of the 30 subjects will self-administer Griffithsin Gel once daily for 14 consecutive days, with 5 doses administered under clinical supervision and the remaining 9 doses administered at home. |
| Placebo Gel | Placebo comparator | Drug: Placebo GelIn the randomized period, duration of treatment will be 14 days; each of the 30 subjects will self-administer placebo gel once daily for 14 consecutive days, with 5 doses administered under clinical supervision and the remaining 9 doses administered at home. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 1) Between 18 and 49 years of age (at screening), inclusive.
- 2) Willing and able to provide written informed consent.
- 3) Healthy, based on medical history, vital signs, physical examination, urinalysis, laboratory evaluations for genital infections and laboratory evaluations for hematology, liver and renal function.
- 4) HIV-negative as determined by HIV ELISA test at screening.
- 5) In the absence of the use of exogenous hormone(s), have a self-reported regular menstrual cycle, defined as having a minimum of 21 days and a maximum of 35 days between menses.
Key exclusion criteria (16 listed)
- 1) History of or known sensitivity/allergy to any component of either study product.
- 2) Currently pregnant or breast-feeding, or within 3 months of last pregnancy outcome.
- 3) Participation in any other clinical research trial involving investigational or marketed products currently or within two months of participation prior to screening, including any trial of a spermicide, microbicide and/or drug.
- 4) Known bleeding disorder that could lead to prolonged or continuous bleeding with biopsy.
- 5) Diagnosed with or treated for any STI or pelvic inflammatory disease in the last 3 months. Note: Women with a history of condylomata or genital herpes who have been asymptomatic for at least six months may be considered for eligibility.
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 |
|---|---|---|
| Griffithsin GelGriffithsin Gel is a large biologic molecule that is intended for vaginal rather than systemic administration. In addition, Griffithsin Gel is being developed for the prevention of HIV infection and not as a therapeutic agent. The concentration of Griffithsin Gel associated with prevention of HIV in vitro and in vivo has been established in non-clinical studies (see Section 5). Studies have demonstrated that Griffithsin Gel is highly potent for HIV prevention and is effective at very low concentrations. One 4 mL dose of PC-6500, designed to provide an adequate vaginal concentration of GRFT for the prevention of HIV, based on preclinical data, will be evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be minimally absorbed systemically, if at all. | Drug | Griffithsin Gel |
| Placebo GelPlacebo Gel | Drug | Placebo Gel |
Primary outcome
Number and percent of participants with TEAEs, SAEs and AEs leading to premature discontinuation.
Time frame: 10 months
To evaluate the safety of PC-6500 gel used vaginally for a single dose; and then for 14 consecutive days of dosing. AEs will be coded in accordance with the current version of the Medical Dictionary for Regulatory Activities (MedDRA).
1 secondary outcome
Evaluation of the area under the time-concentration curve of Griffithsin gel in blood during and after dosing as assessed by (AUC0-last; AUC0-∞)
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 35051209Teleshova N, Keller MJ, Fernandez Romero JA, Friedland BA, Creasy GW, Plagianos MG, Ray L, Barnable P, Kizima L, Rodriguez A, Cornejal N, Melo C, Cruz Rodriguez G, Mukhopadhyay S, Calenda G, Sinkar SU, Bonnaire T, Wesenberg A, Zhang S, Kleinbeck K, Palmer K, Alami M, O'Keefe BR, Gillevet P, Hur H, Liang Y, Santone G, Fichorova RN, Kalir T, Zydowsky TM. Results of a phase 1, randomized, placebo-controlled first-in-human trial of griffithsin formulated in a carrageenan vaginal gel. PLoS One. 2022 Jan 20;17(1):e0261775. doi: 10.1371/journal.pone.0261775. eCollection 2022.
- 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: No
Related trials for HIV Infection
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.
George Creasy, MD study chair
Population Council
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 Griffithsin Gel in people with HIV Infection, run by Population Council 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 9 inclusion and 16 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 27 Nov 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and percent of participants with TEAEs, SAEs and AEs leading to premature discontinuation. (time frame: 10 months). 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 NCT02875119, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.