Please assess the completion status of the following clinical trial:

Trial Title: Optimization of a Tenofovir Enema for HIV Prevention

Study Design Characteristics:
- Allocation: NON_RANDOMIZED
- Intervention Model: SINGLE_GROUP
- Observational Model: None
- Primary Purpose: OTHER
- Time Perspective: None
- Masking: NONE
- Phase: PHASE1
- Number of Arms: 5.0

Eligibility Criteria:
Inclusion Criteria:~1. 18 years of age or older at screening~2. Willing and able to communicate in English~3. Willing and able to provide written informed consent to take part in the study~4. Willing and able to provide adequate locator information~5. Understand and agree to local Sexually Transmitted Infection (STI) reporting requirements~6. Biologically male~7. HIV-1 uninfected at screening as documented by Combo Ag/Ab HIV-1/HIV-2 immunoassay (refer to Appendix II for confirmatory testing algorithm)~8. Available to return for all study visits, barring unforeseen circumstances~9. Per participant report at screening, a history of consensual Receptive Anal Intercourse (RAI) at least five times in lifetime and at least once in the prior 3 months (Required to ensure that participants are sufficiently sexually active to complete take-home enema study requirements)~10. Per participant report at screening, experience with receiving or self-administering an enema or douche in the past year.~11. Willing to abstain from insertion of anything (drug/medication, penis, object, sex toy, or enema including take-home enema) into the anorectum for 72 hours before and after each research unit study product exposure and 7 days after each flexible sigmoidoscopy with biopsy collection.~12. Willing to refrain from aspirin and NSAID use for one week before and after each study biopsy visit~13. Willing and able to use condoms provided by the study for all Receptive Anal Intercourse (RAI) for the duration of participation~14. Agrees not to participate in other research studies involving drugs and/ or medical devices for the duration of the study~Exclusion Criteria:~1. History of chronic Hepatitis B infection, as documented by positive HBsAg at screening~2. ≥ Grade 2 laboratory abnormality at baseline as defined by The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 dated November 2014~3. 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)~4. At screening or within the past 2 months: participant-reported symptoms and/or clinical or laboratory diagnosis of active rectal or reproductive tract infection requiring treatment per current Centers for Disease Control and Prevention (CDC) guidelines or symptomatic urinary tract infection (UTI). Infections requiring treatment include Chlamydia (CT), gonorrhea (GC), syphilis, active Herpes Simplex Virus (HSV) lesions, chancroid, genital sores or ulcers, and, if clinically indicated, genital warts. Note that HSV seropositivity with no active genital lesions is not an exclusion criterion, since treatment is not required.~5. History of an underlying cardiac arrhythmia or renal disease (including creatinine clearance \<50 mL/min using Cockcroft-Gault equation)~6. History of severe or recent cardiac or pulmonary event~7. History of aortic aneurysm~8. History of significant gastrointestinal bleeding~9. Current use of warfarin or heparin or other anticoagulant medications associated with increased risk for bleeding following mucosal biopsy (e.g., daily high dose aspirin \[\>81 mg\], NSAIDs, or Pradaxa®)~10. Use of systemic or anorectal immunomodulatory medications within 4 weeks of enrollment or planned use at any time during study participation~11. Use of pre-exposure (PrEP) and post-exposure (PEP) prophylaxis for HIV exposure within 3 weeks of enrollment or planned use within 3 weeks prior to any study visit with PK sampling.~12. Per participant report, use of any rectally administered products containing N-9 (including condoms) or investigational products within 4 weeks of enrollment, or planned use of either at any time during study participation~13. Known allergic reaction to TFV or other components of the test articles~14. Current known HIV-infected partners~15. History of recurrent urticaria~16. For JHU only: Participants whose whole body (Effective Dose Equivalent or EDE) radiation exposure, per the investigator's records and/or participant report, exceeds 5000 Millirem (mRem)/year~17. Symptoms suggestive of acute HIV seroconversion at screening and enrollment~18. Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease.

- Gender: MALE
- Minimum Age: 18 Years
- Maximum Age: None
- Healthy Volunteers: t

Study Arms:
- Product A dose (Type: ACTIVE_COMPARATOR): Product A will contain tenofovir (TFV) 220 mg in 125 mL iso-osmolar solution: Participants will have a single dose administered in clinic or a research unit, followed by various specimen collections over 8 days, according to individual sampling schedule assigned to each participant; specimens will be collected on Day 1, 2, 4, and 8.
- Product B dose (Type: ACTIVE_COMPARATOR): Product B will contain tenofovir (TFV) \*660 mg in 125 mL iso-osmolar solution: Participants will have a single dose administered in clinic or a research unit, followed by various specimen collections over 8 days, according to individual sampling schedule assigned to each participant; specimens will be collected on Day 1, 2, 4, and 8.
- Product C dose (Type: ACTIVE_COMPARATOR): Product C will contain tenofovir (TFV) \*660 mg in 125 mL hypo-osmolar solution at half the osmolarity of iso-osmolar solution: Participants will have a single dose administered in clinic or a research unit, followed by various specimen collections over 8 days, according to individual sampling schedule assigned to each participant; specimens will be collected on Day 1, 2, 4, and 8.
- Take-home normal saline (NS) enema (Type: PLACEBO_COMPARATOR): The normal saline (NS) solution will be provided following administration of Product A which is iso-osmolar. The volume of NS enema (120 mL) was selected to approximately match that of Product A (125 mL)
- Take-home half normal saline (½ NS) enema (Type: PLACEBO_COMPARATOR): The ½ normal saline (½ NS) solution will be provided following administration of Product C which is hypo-osmolar. The volume of the ½ NS enema (120 mL) was selected to approximately match that of Product C (125 mL)

Based on this trial design, predict the completion outcome and termination type (if applicable).

Answer: outcome: complete