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

ViiV Healthcare

Status and phase: Completed; Phase 4

Conditions: AIDS

Treatments: Drug: Maraviroc; Drug: Placebo; Drug: Vardenafil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00853840

A4001074

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups, including a placebo group

1.

Experimental group

Description:

Maraviroc + Vardenafil

Treatment:

Drug: Maraviroc

Drug: Maraviroc

Drug: Vardenafil

2.

Placebo Comparator group

Description:

Maraviroc + Placebo

Treatment:

Drug: Placebo

Drug: Maraviroc

Drug: Maraviroc