Trial Outcomes & Findings for Concentrations of Raltegravir in the Semen of HIV-Infected Men (NCT NCT01045265)

Results Overview

Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.

Recruitment status

COMPLETED

Target enrollment

16 participants

Primary outcome timeframe

6 months

Results posted on

2014-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Men on Raltegravir HIV-infected men on chronic therapy with raltegravir 400 mg per day as part of antiretroviral therapy regimen.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Concentrations of Raltegravir in the Semen of HIV-Infected Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Men on Raltegravir n=16 Participants Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	48 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment Canada	16 participants n=5 Participants
CD4 Count	450 cells/mm^3 n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Determine if concentrations of raltegravir in semen exceed the 50% and 95% inhibitory concentrations of HIV during the dosing interval.

Outcome measures

Outcome measures
Measure	16 Male HIV-positive Patients n=16 Participants Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
Seminal Concentrations of Raltegravir. C-min	0.18 mg/l Interval 0.13 to 0.24
Seminal Concentrations of Raltegravir. C-max	1.91 mg/l Interval 1.46 to 4.33

SECONDARY outcome

Timeframe: 6 months

Determine the extent of raltegravir penetration into semen by obtaining semen to plasma ratios across the dosing interval.

Outcome measures

Outcome measures
Measure	16 Male HIV-positive Patients n=16 Participants Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
Semen to Plasma Raltegravir Concentrations	3.25 ratio Interval 1.46 to 5.37

SECONDARY outcome

Timeframe: 6 months

Determine the area under the concentration time curve of raltegravir in semen.

Outcome measures

Outcome measures
Measure	16 Male HIV-positive Patients n=16 Participants Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
Seminal Distribution of Raltegravir	6.83 h mg/l Interval 5.24 to 13.47

SECONDARY outcome

Timeframe: 6 months

Determine the variability in the penetration of raltegravir into the seminal compartment over the raltegravir dosing period.

Outcome measures

Outcome measures
Measure	16 Male HIV-positive Patients n=16 Participants Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
Semen to Plasma Distribution of Raltegravir	2.26 ratio Interval 1.05 to 4.45

Adverse Events

Men on Raltegravir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tony Antoniou

Maple Leaf Research

Phone: 4164657936

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60