Trial Outcomes & Findings for Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission (NCT NCT01053741)

Last Updated: 2017-05-25

Results Overview

Endoscopy will be performed to obtain biopsy specimens at baseline and following each inpatient enema exposure. Samples will be obtained at each flexible sigmoidoscopy and set aside for batch sectioning and H\&E staining. Slides will be reviewed and scored by a qualified pathologist blinded to treatment assignment using a qualitative scoring system. This scoring system uses semi-quantitative scoring that focuses on acute toxicity to epithelial cell layer similar to that seen in animal studies. This is a categorical grading scale, where 0 = Epithelial surface intact;1 = \<1/3 of surface denuded; 2 = 1/3 - 2/3rds of surface denuded;3 = More than 2/3rds of surface denuded. Six separate biopsies for each subject and each treatment intervention were analyzed in a multi-level analysis. In comparison with the baseline condition (no intervention), the odds and 95% confidence interval (CI) of having a higher epithelial denudation score were calculated for each intervention.

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

One hour

Results posted on

2017-05-25

Participant Flow

Recruitment initiated September 2008, completed October 2009. Study participants recruited from previous trial participation and advertisements posted in the medical institutions.

Participant milestones

Participant milestones
Measure	Seminal Fluid, Then Normosol-R Subjects first received 2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Than a two week pause between interventions. Followed by 2.5 mL radiolabeled Normosol-R administered rectally x1.	Normosol-R Then Seminal Fluid Subjects first received 2.5 mL radiolabeled Normosol-R administered rectally x1. Then a two week pause between interventions. Followed by 2.5 mL radiolabeled autologous seminal fluid administered rectally x1.
1st Intervention STARTED	5	6
1st Intervention COMPLETED	5	6
1st Intervention NOT COMPLETED	0	0
14 Day Washout STARTED	5	6
14 Day Washout COMPLETED	5	6
14 Day Washout NOT COMPLETED	0	0
2nd Study Intervention STARTED	5	6
2nd Study Intervention COMPLETED	5	5
2nd Study Intervention NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Seminal Fluid, Then Normosol-R Subjects first received 2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Than a two week pause between interventions. Followed by 2.5 mL radiolabeled Normosol-R administered rectally x1.	Normosol-R Then Seminal Fluid Subjects first received 2.5 mL radiolabeled Normosol-R administered rectally x1. Then a two week pause between interventions. Followed by 2.5 mL radiolabeled autologous seminal fluid administered rectally x1.
2nd Study Intervention Physician Decision	0	1

Baseline Characteristics

Effect of Seminal Fluid on the Colon Wall; Implications for HIV Transmission

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Seminal Fluid Then Normosol n=5 Participants 2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled Normosol-R administered rectally X1. Radiolabeled autologous seminal fluid: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle. Radiolabeled Normosol-R: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle.	Normosol-R Then Seminal Fluid n=5 Participants 2.5 mL radiolabeled Normosol-R administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled autologous seminal fluid administered rectally X1. Radiolabeled autologous seminal fluid: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle. Radiolabeled Normosol-R: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle.	Total n=10 Participants Total of all reporting groups
Age, Continuous	44 years n=5 Participants	40 years n=7 Participants	41.5 years n=5 Participants
Sex/Gender, Customized Male gender	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	10 participants n=5 Participants

PRIMARY outcome

Timeframe: One hour

Outcome measures

Outcome measures
Measure	Seminal Fluid n=10 Participants Seminal Fluid Intervention	Normosol-R n=10 Participants Normosol-R Intervention
Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention.	1.0 units on a scale Interval 0.92 to 1.17	1.17 units on a scale Interval 1.04 to 1.46

Adverse Events

Seminal Fluid

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Normosol-R

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Seminal Fluid n=10 participants at risk Seminal Fluid Intervention	Normosol-R n=10 participants at risk Normosol-R Intervention
Gastrointestinal disorders Gas/bloating	40.0% 4/10 • Number of events 4	30.0% 3/10 • Number of events 3

Additional Information

Associate Director, Drug Development Unit

Johns Hopkins School of Medicine

Phone: (410)614-8762

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place