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Antiretroviral

Active for Safety Concerns (RITE PrEP Trial)

Phase 1

Recruiting

Led By Cassie Grimsley Ackerley, MD, MSc

Research Sponsored by Eastern Virginia Medical School

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Individuals between the ages of 18-59 years

Lifetime history of receptive anal intercourse

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 24 hours after last rectal dose administration of study product in each dosing phase.

Awards & highlights

RITE PrEP Trial Summary

"This trial is testing the safety and how the body processes two rectal inserts over a two-phase study. Participants will receive the inserts for 3 days in a row, followed by every other day for

Who is the study for?

The RITE PrEP study is for individuals aged 18-59 who have a history of receptive anal intercourse, are HIV-negative, and can give informed consent. They must be willing to undergo various tests including blood, urine, and rectal biopsies. Women must agree to additional cervicovaginal secretion collection. Participants should not have bowel conditions that could worsen with the study or distort anatomy.Check my eligibility

What is being tested?

This trial is testing the safety and how the body processes TAF/EVG rectal inserts compared to placebo inserts over several days. It's double-blind (neither researchers nor participants know who gets what), randomized (assigned by chance), and involves two phases with different dosing schedules.See study design

What are the potential side effects?

Potential side effects may include discomfort at the site of insertion or biopsy, allergic reactions to insert components, gastrointestinal issues due to insert ingredients or procedures involved in sample collections like biopsies.

RITE PrEP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 59 years old.

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I have had receptive anal intercourse in my life.

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I understand the study and can give my consent.

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I am willing to provide cervicovaginal samples for the study.

RITE PrEP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 24 hours after last rectal dose administration of study product in each dosing phase.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 24 hours after last rectal dose administration of study product in each dosing phase.

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 hours after last rectal dose administration of study product in each dosing phase. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency and intensity of Adverse Events

PK (Cmax) in rectal mucosal tissue

PK (Cmax) in rectal secretions

+1 more

Secondary outcome measures

Cytokine Profiles

Microbiome Profiles

PK (Cmax) in cervicovaginal secretions

+1 more

RITE PrEP Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention

2 TAF/EVG (20/16mg) rectal inserts

Group II: PlaceboPlacebo Group1 Intervention

2 Matching placebo inserts

0 / 4Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Centers for Disease Control and PreventionFED

875 Previous Clinical Trials

22,477,378 Total Patients Enrolled

Eastern Virginia Medical SchoolLead Sponsor

69 Previous Clinical Trials

14,427 Total Patients Enrolled

CONRADOTHER

58 Previous Clinical Trials

11,589 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Active have approval from the FDA?

"On a 3-point scale, Active was rated as 1 in terms of safety by our team at Power. This assessment is due to the trial being categorized as Phase 1, indicating scant data backing its safety and effectiveness."

Answered by AI

Are there currently any available slots for new participants in this medical trial?

"Indeed, the details available on clinicaltrials.gov highlight that this trial is actively in search of participants. This study was initially posted on January 16th, 2024, and underwent its latest revision on February 15th, 2024. The research aims to enroll a total of 24 individuals at one specific site."

Answered by AI

What is the number of individuals currently undergoing treatment within this medical study?

"Yes, the details on clinicaltrials.gov indicate that this trial is currently seeking volunteers. The trial was first listed on January 16th, 2024 and last modified on February 15th, 2024. This research aims to recruit a total of 24 participants from one location."

Answered by AI

What is the main objective of this clinical trial?

"The primary objective of this trial is to assess Pharmacokinetics (PK) by measuring the maximum concentration (Cmax) in blood at 24 and 72 hours post final rectal dose administration. Secondary endpoints involve evaluating PK (Cmax) in cervicovaginal secretions, specifically concentrations of TFV and EVG; examining PK (Cmax) in cervicovaginal mucosal tissues, focusing on concentrations of TFV-DP and EVG; and analyzing Microbiome Profiles to detect alterations in rectal and vaginal microbiome composition."

Answered by AI