Trial Outcomes & Findings for Concentrations of Maraviroc in the Semen of HIV-Infected Men (NCT NCT01009034)

Results Overview

We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Speciﬁ- cally, semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.

Recruitment status

COMPLETED

Target enrollment

14 participants

Primary outcome timeframe

Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample.

Results posted on

2014-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	10 Male HIV-positive Patients Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months. Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.
Overall Study STARTED	14
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	10 Male HIV-positive Patients Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months. Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Concentrations of Maraviroc in the Semen of HIV-Infected Men

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	10 Male HIV-positive Patients n=14 Participants Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months. Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.
Age, Continuous	51 years n=93 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Region of Enrollment Canada	14 participants n=93 Participants

PRIMARY outcome

Timeframe: Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample.

Population: We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals.

We used a staggered sampling approach in which semen samples were produced by participants over several days at different sampling times relative to the morning dose of antiretrovirals. Speciﬁ- cally, semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. We collected corresponding blood samples within 1 hour of the semen sample. For each participant a single value (the HIV concentration ratio) was calculated as the minimum HIV concentration in the semen over the minimum HIV concentration in the blood throughout the dosing interval.

Outcome measures

Outcome measures
Measure	10 Male HIV-positive Patients n=10 Participants Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months. Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.
Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral. dar	0.20 Inhibitory concentration ratio Interval 0.14 to 0.24
Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral. evr	0.16 Inhibitory concentration ratio Interval 0.15 to 0.23
Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral. mar	0.92 Inhibitory concentration ratio Interval 0.59 to 1.91
Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral. ral	4.32 Inhibitory concentration ratio Interval 4.1 to 5.0

SECONDARY outcome

Timeframe: Semen samples were collected 30 minutes to 1 hour before the morning dose of medication (day 1), and then at hours 1, 2, 4, 8, and 12 postdrug ingestion on days 2-6. Blood samples were collected within 1 hour of the semen sample

For each participant, the Maraviroc penetration ratio was calculated as the maximum Maraviroc concentration in the semen over the maximum Maraviroc concentration in the blood throughout the dosing interval.

Outcome measures

Outcome measures
Measure	10 Male HIV-positive Patients n=10 Participants Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months. Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.
Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval	0.62 ratio Interval 0.23 to 2.45

SECONDARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	10 Male HIV-positive Patients n=10 Participants Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months. Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period.
Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.	3.43 h*mg/L Interval 1.83 to 7.96

Adverse Events

12 Male HIV-positive Patients

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