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Concentrations of Maraviroc in the Semen of HIV-Infected Men (NCT01009034)

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ClinicalTrials.gov Identifier: NCT01009034
Recruitment Status : Completed
First Posted : November 6, 2009
Results First Posted : September 9, 2014
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Canadian Immunodeficiency Research Collaborative

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Maraviroc Concentrations in Semen
Intervention Other: Measuring semen samples
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 10 Male HIV-positive Patients
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 14
Completed 10
Not Completed 4
Reason Not Completed
Lost to Follow-up             2
Withdrawal by Subject             2
Arm/Group Title 10 Male HIV-positive Patients
Hide Arm/Group Description

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 Number of Baseline Participants 14
Hide Baseline Analysis Population Description
10 HIV+ men on maraviroc with VL <50 copies per M
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 14 participants
51
(46 to 57)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
0
   0.0%
Male
14
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 14 participants
14
1.Primary Outcome
Title Semen to Plasma Ratio of HIV Concentration During the Dosing Interval for Dar, Evr, Mar & Ral.
Hide Description 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.
Time Frame 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.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 10 Male HIV-positive Patients
Hide Arm/Group Description:

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 Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: Inhibitory concentration ratio
dar
0.20
(0.14 to 0.24)
evr
0.16
(0.15 to 0.23)
mar
0.92
(0.59 to 1.91)
ral
4.32
(4.1 to 5.0)
2.Secondary Outcome
Title Determine the Extent of Maraviroc Penetration Into Semen by Obtaining Semen to Plasma Ratios Across the Dosing Interval
Hide Description 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.
Time Frame 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 10 Male HIV-positive Patients
Hide Arm/Group Description:

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 Number of Participants Analyzed 10
Mean (Inter-Quartile Range)
Unit of Measure: ratio
0.62
(0.23 to 2.45)
3.Secondary Outcome
Title Determine the Area Under the Concentration Time Curve of Maraviroc in Semen.
Hide Description [Not Specified]
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 10 Male HIV-positive Patients
Hide Arm/Group Description:

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 Number of Participants Analyzed 10
Median (Inter-Quartile Range)
Unit of Measure: h*mg/L
3.43
(1.83 to 7.96)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 12 Male HIV-positive Patients
Hide Arm/Group Description

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.

All-Cause Mortality
12 Male HIV-positive Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
12 Male HIV-positive Patients
Affected / at Risk (%)
Total   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
12 Male HIV-positive Patients
Affected / at Risk (%)
Total   0/10 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Tony Antoniou
Organization: Maple Leaf Research
Phone: 4164657936
Responsible Party: Canadian Immunodeficiency Research Collaborative
ClinicalTrials.gov Identifier: NCT01009034     History of Changes
Other Study ID Numbers: WS 353380
First Submitted: November 5, 2009
First Posted: November 6, 2009
Results First Submitted: June 16, 2014
Results First Posted: September 9, 2014
Last Update Posted: September 9, 2014