Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-05-31

Brief Summary

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The objective of this study was to estimate the effects of a single dose of vardenafil on the blood pressure (BP) in subjects receiving maraviroc (MVC) (dosed to steady-state) and to assess the safety and tolerability of MVC in subjects receiving a single dose of vardenafil.

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Detailed Description

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Conditions

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AIDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1.

Maraviroc + Vardenafil

Group Type EXPERIMENTAL

Maraviroc

Intervention Type DRUG

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.

Vardenafil

Intervention Type DRUG

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.

2.

Maraviroc + Placebo

Group Type PLACEBO_COMPARATOR

Maraviroc

Intervention Type DRUG

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.

Placebo

Intervention Type DRUG

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.

Interventions

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Maraviroc

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.

Intervention Type DRUG

Vardenafil

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.

Intervention Type DRUG

Maraviroc

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.

Intervention Type DRUG

Placebo

Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.

Intervention Type DRUG

Other Intervention Names

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Celsentri, Selzentry Selzentry, Celsentri

Eligibility Criteria

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Inclusion Criteria

* Healthy male subjects. no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram and clinical laboratory tests.
* Body mass index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Subjects with a supine systolic BP of greater than 140 mm Hg, or a supine diastolic BP of greater than 90 mm Hg, either at Screening or at the predose measurements.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes