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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00853840
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : June 23, 2009
Last Update Posted : January 25, 2013
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition AIDS
Interventions Drug: Maraviroc
Drug: Vardenafil
Drug: Placebo
Enrollment 18
Recruitment Details  
Pre-assignment Details All subjects received 3 to 4 days of maraviroc 300 mg twice daily (BID) before receiving single oral doses of either vardenafil 20 mg (Treatment A) or placebo (Treatment B).
Arm/Group Title Vardenafil + Maraviroc Non-matching Placebo + Maraviroc
Hide Arm/Group Description On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing. On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
Period Title: Period 1
Started 9 9
Maraviroc (Days 1 - 4) 9 9
Vardenafil or Placebo (Day 4) 9 [1] 9 [1]
Completed 9 9
Not Completed 0 0
[1]
Administered 1 hour post Maraviroc dosing
Period Title: Period 2
Started 9 9
Maraviroc (Days 1 - 3) 9 9
Vardenafil or Placebo (Day 3) 9 [1] 9 [1]
Completed 9 9
Not Completed 0 0
[1]
Administered 1 hour post Maraviroc dosing
Arm/Group Title All Subjects
Hide Arm/Group Description In this 2-way crossover study, in Period 1, all 18 subjects were randomized to receive a single dose of either vardenafil 20 mg (Treatment A) or placebo (Treatment B), subsequent to treatment with 3 to 4 days of maraviroc 300 mg BID. All subjects were then crossed over to receive the second treatment in Period 2.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
34.6  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
0
   0.0%
Male
18
 100.0%
1.Primary Outcome
Title Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Hide Description Supine BP was taken after subjects rested for 5 minutes supine. Subjects then sat for 2 minutes and stood for 2 minutes then standing BP taken. Duplicate supine and standing BP measurements were taken per the protocol. The average of the duplicate measurements was calculated prior to data analysis.
Time Frame 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose
Hide Outcome Measure Data
Hide Analysis Population Description
The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.
Arm/Group Title Maraviroc + Vardenafil (Treatment A) Maraviroc + Placebo (Treatment B)
Hide Arm/Group Description:
On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
Overall Number of Participants Analyzed 18 18
Least Squares Mean (Standard Error)
Unit of Measure: mm Hg
Supine Systolic BP: 1.5 hour post Maraviroc dose 118.36  (1.1523) 119.47  (1.1523)
Supine Diastolic BP: 1.5 hour post Maraviroc dose 68.06  (0.7184) 69.99  (0.7184)
Supine Systolic BP: 2 hour post Maraviroc dose 113.45  (1.1523) 118.44  (1.1523)
Supine Diastolic BP: 2 hour post Maraviroc dose 66.31  (0.7184) 69.27  (0.7184)
Supine Systolic BP: 2.5 hour post Maraviroc dose 114.67  (1.1523) 119.55  (1.1523)
Supine Diastolic BP: 2.5 hour post Maraviroc dose 66.98  (0.7184) 70.80  (0.7184)
Supine Systolic BP: 3 hour post Maraviroc dose 114.11  (1.1523) 116.16  (1.1523)
Supine Diastolic BP: 3 hour post Maraviroc dose 67.28  (0.7184) 69.05  (0.7184)
Supine Systolic BP: 4 hour post Maraviroc dose 115.89  (1.1523) 117.97  (1.1523)
Supine Diastolic BP: 4 hour post Maraviroc dose 68.37  (0.7184) 69.24  (0.7184)
Supine Systolic BP: 6 hour post Maraviroc dose 116.45  (1.1523) 118.75  (1.1523)
Supine Diastolic BP: 6 hour post Maraviroc dose 65.67  (0.7184) 66.52  (0.7184)
Supine Systolic BP: 8 hour post Maraviroc dose 116.61  (1.1523) 120.83  (1.1523)
Supine Diastolic BP: 8 hour post Maraviroc dose 66.34  (0.7184) 68.85  (0.7184)
Supine Systolic BP: 12 hour post Maraviroc dose 122.81  (1.1523) 124.75  (1.1523)
Supine Diastolic BP: 12 hour post Maraviroc dose 67.95  (0.7184) 70.27  (0.7184)
Standing Systolic BP: 1.5 hour post Maraviroc dose 120.82  (1.6525) 125.18  (1.6525)
Standing Diastolic BP 1.5 hour post Maraviroc dose 74.81  (1.0102) 78.74  (1.0102)
Standing Systolic BP: 2 hour post Maraviroc dose 118.49  (1.6525) 125.40  (1.6525)
Standing Diastolic BP: 2 hour post Maraviroc dose 74.90  (1.0102) 80.69  (1.0102)
Standing Systolic BP: 2.5 hour post Maraviroc dose 115.52  (1.6525) 121.32  (1.6525)
Standing Diastolic BP 2.5 hour post Maraviroc dose 72.29  (1.0102) 78.94  (1.0102)
Standing Systolic BP: 3 hour post Maraviroc dose 117.10  (1.6525) 121.37  (1.6525)
Standing Diastolic BP: 3 hour post Maraviroc dose 73.73  (1.0102) 77.38  (1.0102)
Standing Systolic BP: 4 hour post Maraviroc dose 119.35  (1.6525) 121.40  (1.6525)
Standing Diastolic BP: 4 hour post Maraviroc dose 77.29  (1.0102) 78.38  (1.0102)
Standing Systolic BP: 6 hour post Maraviroc dose 118.29  (1.6525) 120.59  (1.6525)
Standing Diastolic BP: 6 hour post Maraviroc dose 73.34  (1.0102) 76.77  (1.0102)
Standing Systolic BP: 8 hour post Maraviroc dose 120.43  (1.6525) 123.90  (1.6525)
Standing Diastolic BP: 8 hour post Maraviroc dose 74.06  (1.0102) 77.32  (1.0102)
Standing Systolic BP: 12 hour post Maraviroc dose 128.38  (1.6525) 128.65  (1.6525)
Standing Diastolic BP: 12 hour post Maraviroc dose 78.65  (1.0102) 80.91  (1.0102)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

1.5 hour post-dose for supine systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.11
Confidence Interval 90%
-3.80 to 1.59
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

1.5 hour post-dose for supine diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.93
Confidence Interval 90%
-3.55 to -0.31
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2 hour post-dose for supine systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.99
Confidence Interval 90%
-7.69 to -2.30
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2 hour post-dose for supine diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.96
Confidence Interval 90%
-4.58 to -1.34
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2.5 hour post-dose for supine systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.88
Confidence Interval 90%
-7.58 to -2.19
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2.5 hour post-dose for supine diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.82
Confidence Interval 90%
-5.44 to -2.20
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

3 hour post-dose for supine systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.05
Confidence Interval 90%
-4.74 to 0.64
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

3 hour post-dose for supine diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.76
Confidence Interval 90%
-3.38 to -0.15
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

4 hour post-dose for supine systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.08
Confidence Interval 90%
-4.77 to 0.62
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

4 hour post-dose for supine diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.88
Confidence Interval 90%
-2.49 to 0.74
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

6 hour post-dose for supine systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.30
Confidence Interval 90%
-4.99 to 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

6 hour post-dose for supine diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.85
Confidence Interval 90%
-2.47 to 0.77
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

8 hour post-dose for supine systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.22
Confidence Interval 90%
-6.91 to -1.52
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

8 hour post-dose for supine diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.51
Confidence Interval 90%
-4.13 to -0.90
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

12 hour post-dose for supine systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.94
Confidence Interval 90%
-4.63 to 0.76
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

12 hour post-dose for supine diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.32
Confidence Interval 90%
-3.94 to -0.70
Estimation Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

1.5 hour post-dose for standing systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.36
Confidence Interval 90%
-8.22 to -0.50
Estimation Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

1.5 hour post-dose for standing diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.93
Confidence Interval 90%
-6.29 to -1.56
Estimation Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2 hour post-dose for standing systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.91
Confidence Interval 90%
-10.77 to -3.05
Estimation Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2 hour post-dose for standing diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.79
Confidence Interval 90%
-8.15 to -3.42
Estimation Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2.5 hour post-dose for standing systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -5.80
Confidence Interval 90%
-9.66 to -1.94
Estimation Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2.5 hour post-dose for standing diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -6.65
Confidence Interval 90%
-9.01 to -4.29
Estimation Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

3 hour post-dose for standing systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.27
Confidence Interval 90%
-8.13 to -0.41
Estimation Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

3 hour post-dose for standing diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.65
Confidence Interval 90%
-6.01 to -1.29
Estimation Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

4 hour post-dose for standing systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.05
Confidence Interval 90%
-5.91 to 1.81
Estimation Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

4 hour post-dose for standing diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -1.09
Confidence Interval 90%
-3.46 to 1.27
Estimation Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

6 hour post-dose for standing systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.30
Confidence Interval 90%
-6.16 to 1.56
Estimation Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

6 hour post-dose for standing diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.43
Confidence Interval 90%
-5.79 to -1.06
Estimation Comments [Not Specified]
Show Statistical Analysis 29 Hide Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

8 hour post-dose for standing systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.47
Confidence Interval 90%
-7.33 to 0.39
Estimation Comments [Not Specified]
Show Statistical Analysis 30 Hide Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

8 hour post-dose for standing diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.26
Confidence Interval 90%
-5.62 to -0.90
Estimation Comments [Not Specified]
Show Statistical Analysis 31 Hide Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

12 hour post-dose for standing systolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.27
Confidence Interval 90%
-4.13 to 3.59
Estimation Comments [Not Specified]
Show Statistical Analysis 32 Hide Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

12 hour post-dose for standing diastolic BP

Vardenafil minus Placebo

A total sample size of 18 subjects provides 90% confidence intervals for the difference between vardenafil and placebo of ±5.90 on the standing diastolic BP with 98% coverage probability at each time postdose.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.26
Confidence Interval 90%
-4.62 to 0.10
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Standing and Supine Pulse Rate
Hide Description Supine pulse rate measurement was taken after subject rested for 5 minutes supine. Subject sat for 2 minutes, then stood for 2 minutes and standing measurement taken. Duplicate supine and standing pulse rate measurements taken per protocol. Average of duplicate measurements calculated prior to data analysis.
Time Frame 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose
Hide Outcome Measure Data
Hide Analysis Population Description
The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.
Arm/Group Title Maraviroc + Vardenafil (Treatment A) Maraviroc + Placebo (Treatment B)
Hide Arm/Group Description:
On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
Overall Number of Participants Analyzed 18 18
Least Squares Mean (Standard Error)
Unit of Measure: beats per minute (bpm)
Supine pulse rate: 1.5 hours post Maraviroc dose 67.56  (1.3482) 60.61  (1.3482)
Supine pulse rate: 2 hours post Maraviroc dose 66.20  (1.3482) 60.69  (1.3482)
Supine pulse rate: 2.5 hours post Maraviroc dose 61.64  (1.3482) 58.00  (1.3482)
Supine pulse rate: 3 hours post Maraviroc dose 60.42  (1.3482) 57.53  (1.3482)
Supine pulse rate: 4 hours post Maraviroc dose 60.22  (1.3482) 58.16  (1.3482)
Supine pulse rate: 6 hours post Maraviroc dose 71.39  (1.3482) 65.94  (1.3482)
Supine pulse rate: 8 hours post Maraviroc dose 67.67  (1.3482) 63.55  (1.3482)
Supine pulse rate: 12 hours post Maraviroc dose 71.25  (1.3482) 67.80  (1.3482)
Standing pulse rate: 1.5 hours post Maraviroc dose 85.78  (1.6885) 78.45  (1.6885)
Standing pulse rate: 2 hours post Maraviroc dose 85.16  (1.6885) 78.34  (1.6885)
Standing pulse rate: 2.5 hours post Maraviroc dose 82.25  (1.6885) 77.22  (1.6885)
Standing pulse rate: 3 hours post Maraviroc dose 80.05  (1.6885) 75.34  (1.6885)
Standing pulse rate: 4 hours post Maraviroc dose 79.97  (1.6885) 75.92  (1.6885)
Standing pulse rate: 6 hours post Maraviroc dose 93.53  (1.6885) 87.17  (1.6885)
Standing pulse rate: 8 hours post Maraviroc dose 84.41  (1.6885) 79.34  (1.6885)
Standing pulse rate: 12 hours post Maraviroc dose 82.47  (1.6885) 80.59  (1.6885)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

1.5 hour post-dose for supine pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.95
Confidence Interval 90%
4.18 to 9.72
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2 hour post-dose for supine pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.51
Confidence Interval 90%
2.73 to 8.28
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2.5 hour post-dose for supine pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.64
Confidence Interval 90%
0.87 to 6.42
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

3 hour post-dose for supine pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.89
Confidence Interval 90%
0.12 to 5.67
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

4 hour post-dose for supine pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.06
Confidence Interval 90%
-0.71 to 4.83
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

6 hour post-dose for supine pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.45
Confidence Interval 90%
2.68 to 8.22
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

8 hour post-dose for supine pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.12
Confidence Interval 90%
1.34 to 6.89
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

12 hour post-dose for supine pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 3.45
Confidence Interval 90%
0.68 to 6.22
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

1.5 hour post-dose for standing pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 7.33
Confidence Interval 90%
3.70 to 10.95
Estimation Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2 hour post-dose for standing pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.83
Confidence Interval 90%
3.20 to 10.45
Estimation Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

2.5 hour post-dose for standing pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.02
Confidence Interval 90%
1.40 to 8.65
Estimation Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

3 hour post-dose for standing pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.72
Confidence Interval 90%
1.09 to 8.34
Estimation Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

4 hour post-dose for standing pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.05
Confidence Interval 90%
0.43 to 7.67
Estimation Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

6 hour post-dose for standing pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 6.36
Confidence Interval 90%
2.73 to 9.98
Estimation Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

8 hour post-dose for standing pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 5.08
Confidence Interval 90%
1.45 to 8.70
Estimation Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Maraviroc + Vardenafil (Treatment A), Maraviroc + Placebo (Treatment B)
Comments

12 hour post-dose for standing pulse rate

Vardenafil minus Placebo

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Mixed Models Analysis
Comments Sequence, period, time, treatment, & time by treatment interaction as fixed effects, subject within sequence as random effect. Baseline was covariate.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1.88
Confidence Interval 90%
-1.74 to 5.51
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Postural Changes in Systolic and Diastolic Blood Pressure
Hide Description Postural change calculated as position 1 (standing) value minus the position 2 (supine) value. Baseline was the average of 3 predose measurements at each period. Means of replicates were used in calculations.
Time Frame Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg
Hide Outcome Measure Data
Hide Analysis Population Description
The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.
Arm/Group Title Maraviroc + Vardenafil (Treatment A) Maraviroc + Placebo (Treatment B)
Hide Arm/Group Description:
On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: mm Hg
Systolic Blood Pressure: Baseline 3.5  (5.01) 2.6  (4.34)
Diastolic Blood Pressure: Baseline 8.9  (4.69) 7.5  (3.41)
Systolic Blood Pressure: 6 hours 2.2  (5.96) 1.5  (5.14)
Diastolic Blood Pressure: 6 hours 8.4  (4.71) 9.6  (4.36)
Systolic Blood Pressure: 12 hours 5.9  (6.21) 3.5  (5.69)
Diastolic Blood Pressure: 12 hours 11.4  (4.66) 9.9  (4.18)
4.Secondary Outcome
Title Postural Changes in Pulse Rate
Hide Description Postural change calculated as position 1 (standing) value minus position 2 (supine) value. Baseline was the average of the 3 predose measurements at each period. Means of Replicates were used in calculations.
Time Frame Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg
Hide Outcome Measure Data
Hide Analysis Population Description
The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.
Arm/Group Title Maraviroc + Vardenafil (Treatment A) Maraviroc + Placebo (Treatment B)
Hide Arm/Group Description:
On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
Overall Number of Participants Analyzed 18 18
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Baseline 16.0  (7.32) 14.3  (8.05)
6 hours 22.9  (9.10) 20.4  (8.25)
12 hours 12.0  (6.85) 12.0  (8.60)
5.Secondary Outcome
Title Number of Subjects With Postural Hypotension
Hide Description Postural (orthostatic) hypotension defined as 1) decrease in standing-supine diastolic blood pressure (BP) greater than or equal to 10 mm Hg; 2) decrease in standing-supine systolic BP greater than or equal to 20 mm Hg; or 3) standing systolic BP less than 90 mm Hg. Assessed at Period 1 and Period 2 BP measurement timepoints post maraviroc dose.
Time Frame Period 1 and Period 2 (up to 8 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The vital sign analysis population was defined as all enrolled subjects who received at least 1 dose of study medication and had at least 1 vital sign parameter in at least 1 treatment period.
Arm/Group Title Maraviroc + Vardenafil (Treatment A) Maraviroc + Placebo (Treatment B)
Hide Arm/Group Description:
On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Maraviroc Run-In Maraviroc + Vardenafil (Treatment A) Maraviroc + Placebo (Treatment B)
Hide Arm/Group Description All subjects received 3 to 4 days of maraviroc 300 mg twice daily (BID) before receiving single oral doses of either vardenafil 20 mg (Treatment A) or placebo (Treatment B). On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was to be taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing. On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
All-Cause Mortality
Maraviroc Run-In Maraviroc + Vardenafil (Treatment A) Maraviroc + Placebo (Treatment B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Maraviroc Run-In Maraviroc + Vardenafil (Treatment A) Maraviroc + Placebo (Treatment B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/18 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Maraviroc Run-In Maraviroc + Vardenafil (Treatment A) Maraviroc + Placebo (Treatment B)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4   16   5 
Eye disorders       
Phosphenes   0/18 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Eye pain   0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Gastrointestinal disorders       
Abdominal discomfort   1/18 (5.56%)  1/18 (5.56%)  0/18 (0.00%) 
Diarrhoea   0/18 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Nausea   0/18 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Dyspepsia   0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
General disorders       
Fatigue   0/18 (0.00%)  2/18 (11.11%)  0/18 (0.00%) 
Suprapubic pain   1/18 (5.56%)  1/18 (5.56%)  0/18 (0.00%) 
Injury, poisoning and procedural complications       
Tooth fracture   1/18 (5.56%)  1/18 (5.56%)  1/18 (5.56%) 
Investigations       
Hepatic enzyme increased   0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders       
Sensation of heaviness   0/18 (0.00%)  2/18 (11.11%)  1/18 (5.56%) 
Back pain   1/18 (5.56%)  1/18 (5.56%)  1/18 (5.56%) 
Arthralgia   0/18 (0.00%)  1/18 (5.56%)  1/18 (5.56%) 
Myalgia   0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Nervous system disorders       
Headache  1  1/18 (5.56%)  8/18 (44.44%)  1/18 (5.56%) 
Dizziness   0/18 (0.00%)  2/18 (11.11%)  2/18 (11.11%) 
Somnolence   0/18 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Dizziness postural   0/18 (0.00%)  0/18 (0.00%)  1/18 (5.56%) 
Reproductive system and breast disorders       
Erection increased   0/18 (0.00%)  3/18 (16.67%)  0/18 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Nasal congestion   0/18 (0.00%)  8/18 (44.44%)  0/18 (0.00%) 
Nasal dryness   0/18 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Skin and subcutaneous tissue disorders       
Rash   0/18 (0.00%)  1/18 (5.56%)  0/18 (0.00%) 
Vascular disorders       
Hot flush   0/18 (0.00%)  8/18 (44.44%)  0/18 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (v10.1)
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.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential info other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT00853840     History of Changes
Other Study ID Numbers: A4001074
First Submitted: February 27, 2009
First Posted: March 2, 2009
Results First Submitted: May 5, 2009
Results First Posted: June 23, 2009
Last Update Posted: January 25, 2013