A Phase 1 interventional study of TAF/EVG Vaginal Insert in Hiv and HSV, sponsored by CONRAD. Completed at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-16.
Sponsored by CONRAD · Phase 1, Interventional, and Prevention
The purpose of this Phase I study is to assess the safety, pharmacokinetics, and pharmacodynamics of a combination vaginal insert containing tenofovir alafenamide (TAF) and elvitegravir (EVG).
This study will be the first-in-human study for a vaginally administered TAF/EVG insert and will evaluate safety, PK and PD after a single dose. It is hypothesized that the combination insert will be safe and well-tolerated by study participants and that the insert will offer an expanded window of preventive activity and a regimen with flexibility and forgiveness.
This Phase I study aims to complete at least 16 healthy, non-pregnant, HIV-uninfected women aged 18-50 years who are not at risk for pregnancy and are at low risk for sexually transmitted infections (STIs) at one clinical site. The study will examine the safety, PK, PD, disintegration, and acceptability of vaginal inserts containing the combination of tenofovir alafenamide (TAF) and elvitegravir (EVG).
Participants will be randomized (1:1) into one of two sample collection time point groups:
[Timepoint group 1: 4 and 48 hours after using the single combination insert] or [Timepoint group 2: 24 and 72 hours after using the single combination insert]
There will be 5 scheduled visits:
Visit 1 (Screening/Enrollment): Volunteers will be consented and undergo tests and procedures to confirm they are eligible to continue in the study.
Visit 2 (Baseline): Once it has been confirmed that participants are eligible and willing to continue, they will be asked to complete a short baseline questionnaire about the insert. Participants will be randomized to Timepoint group 1 or Timepoint group 2 for sample collection and will then undergo baseline sampling [cervicovaginal (CV) fluid and tissue].
Visit 3 (Insert use and sampling): Participants will use a single combination insert of TAF/EVG in the clinic. Depending upon timepoint randomization, percentage disintegration of the vaginal inserts will be assessed at either 4 hours or 24 hours, and PK and PD sample collection (plasma, CV fluid, and CV tissue) will occur. Participants will also be asked to complete a short acceptability questionnaire.
Visit 4 (Post-Dose Sampling): Participants will undergo sample collection of blood for safety and PK evaluations; and CV fluid and CV tissue for PK at either 48 hours or 72 hours depending upon timepoint randomization.
Visit 5 (Post-Dose Sampling): Participants will undergo a PK sample collection (CV fluid) 7 (±2) days post dose. Participants will be asked about adverse events and concomitant medications taken. Participants will then be exited from the study, unless they have symptoms that require follow-up.
There will be 5 scheduled visits over approximately 1-3 months.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's enrollment of 16 is below the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →CONRAD is the lead sponsor of 39 studies on the registry; none are open to participants now.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Must be protected from pregnancy by one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Post-dose sampling at 4 and 48 hours or at 24 and 72 hours, per randomization
Drug: TAF/EVG Vaginal Insert
1 combination vaginal insert (20mg TAF/16mg EVG)
Number of Participants with Grade 2 or higher treatment-emergent adverse events (TEAEs)
TEAEs are defined as adverse events starting or worsening after administration of the study product; Grade is determined by the DAIDS Grading Table
Time frame: Changes from baseline up to a maximum of 12 days post-dose
Number of participants with adverse events
Adverse events for this outcome are those that are product-related urogenital in nature
Time frame: Changes from baseline up to a maximum of 12 days post-dose
systemic laboratory assessments
Number of participants with abnormal serum chemistry
Time frame: Changes from baseline up to 72 hours post-dose
Systemic Laboratory Assessments
Number of participants with abnormal complete blood count
Time frame: Changes from baseline up to 72 hours post-dose
Drug Concentrations of EVG, TFV, and TAF
Concentrations of EVG, TFV, and TAF in plasma
Time frame: From dosing to 72 hours post-dose
Drug Concentrations of EVG, TFV, and TAF
Concentrations of EVG, TFV, and TAF in CV fluid
Time frame: From dosing to a maximum of 12 days post-dose
Drug Concentrations of EVG, TFV, TFV-DP, and TAF
Concentrations of EVG, TFV, TFV-DP, TAF in CV tissue
Time frame: From dosing to 72 hours post-dose
Percent (%) inhibition of HIV in vaginal cell assay (Anti-HIV activity)
Anti-HIV activity in CV fluid
Time frame: Changes from baseline to 24 hours post-dose
Percent (%) inhibition of HSV in vaginal cell assay (Anti-HSV activity)
Anti-HSV activity in CV fluid
Time frame: Changes from baseline to 24 hours post-dose
Number of participant tissue samples demonstrating HIV-1 infectivity
p24 antigen production in CV tissue infected with HIV-1 ex vivo
Time frame: Changes from baseline to 4 hours post-dose
Disintegration of insert
Percent (%) disintegration at the first evaluation after dosing
Time frame: At 4 or 24 hours post-dose (per randomized time point)
Acceptability of insert: questionnaire
Responses to key questions on acceptability questionnaire (including prior experience with vaginal product use, initial and post-use impressions of insert, dissolution time, discharge amounts, and feelings about real-world use if insert was available for use
Time frame: At baseline and at 48 or 72 hours post-dose (per randomized time point)
HSV infectivity
HSV DNA fold change after ex vivo infection of CV tissue with HSV
Time frame: Changes from baseline to 24 hours post-dose
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2018 to primary completion in Mar 2019, 3 months.
Of 63 non-industry phase 1 interventional studies under Acquired Immunodeficiency Syndrome, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 39. This study's 3 months is below that.
Counting every sponsor, half of 139 studies reached it within 14 months; a quarter within 4 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
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