CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR (NCT06560684) | Clinical Trial Compass
Active — Not RecruitingPhase 2
CROSSOVER STUDY OF ON-DEMAND PREP FORMULATIONS COMPARING RECTAL AND ORAL TENOFOVIR
United States150 participantsStarted 2024-10-29
Plain-language summary
This is a Phase 2, multi-site, two-period, open label randomized crossover (Period 1 and 2) study. Participants are randomized 1:1 to one of two 8-week on-demand product sequences - TFV douche then oral F/TDF or oral F/TDF then TFV douche - with a 2 to 4-week washout period in between. Domains of safety, acceptability, adherence, and PK/PD (sub-study only) are assessed for each product.
Who can participate
Age range18 Years
SexMALE
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Inclusion criteria
✓. Men aged 18 years or older at the time of screening informed consent
✓. Willing and able to provide informed consent to take part in the study
✓. Able to read at a level required for the study components (e.g., CASI and SMS)
✓. Have access to device and the internet for completion of study procedures
✓. Understand and agree to local STI reporting requirements
✓. Non-reactive/negative HIV test results at screening and enrollment
✓. A history of consensual RAI at least five times in their lifetime and at least once in the prior 3 months
✓. Received or self-administered an enema or rectal douche more than half the time prior to engaging in RAI in the past year.
Exclusion criteria
✕. Any reactive/positive HIV test at screening or at least one reactive/positive test result at enrollment, even if HIV infection is not confirmed
✕. History of active (including chronic) hepatitis B virus (HBV) infection, as documented by positive HBV surface antigen (HBsAg) at screening
✕. Co-enrollment in any other interventional research study that may interfere with this study (as provided by self-report or other available documentation). Exceptions may be made after consultation with the Clinical Management Committee (CMC).
What they're measuring
1
Grade 2 or higher adverse events during each study Period
Timeframe: Week 1 through 19
2
Any adverse event leading to study product discontinuation during each study Period
Timeframe: Week 1 through 19
3
Self-report on ease of use, product liking, and likelihood of future use during each study Period
Timeframe: Week 1 through 19
Trial details
NCT IDNCT06560684
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. ≥ Grade 2 clinically significant laboratory abnormality at baseline as defined by The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 dated July 2017, except for estimated glomerular filtration rate (eGFR), which must be \>75 mL/min/1.73m\^2. (Coagulation (PT/INR) results ≥ Grade 2 are not exclusionary for the main study).
✕. Significant colorectal symptom(s) as determined by medical history or by participant self-report (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, history of inflammatory bowel disease, presence of symptomatic external hemorrhoids, and presence of any painful anorectal conditions that would be tender to manipulation)
✕. 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)
✕. History of an underlying clinically significant cardiac arrhythmia or renal disease
✕. History of severe or recent cardiac or pulmonary event