CompletedPhase 1

Rectal Insert TAF/EVG Pre-Exposure Prophylaxis (RITE PrEP) Study

United States21 participantsStarted 2024-01-16

Plain-language summary

This is a double-blind, placebo-controlled, randomized two-phase study to evaluate the safety and pharmacokinetics (PK) of two TAF/EVG inserts administered rectally for 3 consecutive days, then every other day for 14 days.

Who can participate

Age range18 Years – 59 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Individuals between the ages of 18-59 years
✓. Able to understand and give informed consent
✓. HIV-negative and willing to be tested for HIV
✓. Willing to undergo peripheral blood, urine, rectal secretion collection, and rectal biopsy sampling
✓. For those assigned female at birth: Willing to undergo cervicovaginal secretion collection
✓. Lifetime history of receptive anal intercourse
✓. No contraindication to rectal biopsy (at the investigator's discretion)
✓. For participants of childbearing potential: Willing to use an effective method of contraception for at least 30 days prior to enrollment and for the duration of study participation. Effective methods include:

Exclusion criteria

✕. Currently infected with hepatitis virus and/or has liver disease
✕. Current or chronic history of kidney disease or CrCl \<60 ml/min
✕. History of inflammatory bowel disease or other inflammatory, infiltrative, infectious, or vascular condition of the lower GI tract which at the judgement of the investigator, may be worsened by study procedures or may significantly distort the anatomy of the distal large bowel.
✕. Significant laboratory abnormalities at baseline, including but not limited to:
✕. Hemoglobin ≤ 10 g/dL
✕. Platelet count \<100,000
✕. Aspartate aminotransferase (AST) or alanine transaminase (ALT) \>1.3x ULN
✕. Serum creatinine \>1.3x upper limit of normal (ULN)

What they're measuring

Frequency and intensity of Adverse Events

Timeframe: from enrollment until Day 57 (after last rectal dose administration of study product)

Pharmacokinetics (PK) (maximum concentration (Cmax)) in blood

Timeframe: baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.

PK (Cmax) in rectal secretions

Timeframe: baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.

PK (Cmax) in rectal mucosal tissue

Timeframe: at 24 and 72 hours after last rectal dose administration of study product in each Dosing Phase.

Trial details

NCT IDNCT06274398

SponsorEastern Virginia Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-31

View on ClinicalTrials.gov More Safety Issues trials

Who can participate

Age range18 Years – 59 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Individuals between the ages of 18-59 years
✓. Able to understand and give informed consent
✓. HIV-negative and willing to be tested for HIV
✓. Willing to undergo peripheral blood, urine, rectal secretion collection, and rectal biopsy sampling
✓. For those assigned female at birth: Willing to undergo cervicovaginal secretion collection
✓. Lifetime history of receptive anal intercourse
✓. No contraindication to rectal biopsy (at the investigator's discretion)
✓. For participants of childbearing potential: Willing to use an effective method of contraception for at least 30 days prior to enrollment and for the duration of study participation. Effective methods include:

Exclusion criteria

✕. Currently infected with hepatitis virus and/or has liver disease
✕. Current or chronic history of kidney disease or CrCl \<60 ml/min
✕. History of inflammatory bowel disease or other inflammatory, infiltrative, infectious, or vascular condition of the lower GI tract which at the judgement of the investigator, may be worsened by study procedures or may significantly distort the anatomy of the distal large bowel.
✕. Significant laboratory abnormalities at baseline, including but not limited to:
✕. Hemoglobin ≤ 10 g/dL
✕. Platelet count \<100,000
✕. Aspartate aminotransferase (AST) or alanine transaminase (ALT) \>1.3x ULN
✕. Serum creatinine \>1.3x upper limit of normal (ULN)

What they're measuring

Frequency and intensity of Adverse Events

Timeframe: from enrollment until Day 57 (after last rectal dose administration of study product)

Pharmacokinetics (PK) (maximum concentration (Cmax)) in blood

Timeframe: baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.

PK (Cmax) in rectal secretions

Timeframe: baseline and at 24, 48, and 72 hours after last rectal dose administration of study product in each Dosing Phase.

PK (Cmax) in rectal mucosal tissue

Timeframe: at 24 and 72 hours after last rectal dose administration of study product in each Dosing Phase.