AIDSPhase 4NCT00853840

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

A Phase 4 study testing Maraviroc and Vardenafil in people with AIDS, run by ViiV Healthcare at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: AIDS
What is being tested?: Maraviroc and Vardenafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteBelgium
Study dates: Apr 2008to May 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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 locations and contacts

1 site in 1 country.

Belgium1 site

Pfizer Investigational Site
Brussels, 1070

Other trials in Belgium

About this study

Official title: A Randomized, Single-Blinded, Placebo-Controlled Two-Way Crossover Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc

Conditions: AIDS
Being tested: Maraviroc, Vardenafil, Placebo
Keywords: pharmacodynamics. maraviroc, vardenafil, blood pressure
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MaravirocDrug
Also called Celsentri, Selzentry
Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.
VardenafilDrug
Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.
MaravirocDrug
Also called Selzentry, Celsentri
Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.
PlaceboDrug
Maraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.

Study groups in NCT00853840
Study group	Role	What they receive
1.	Experimental	Maraviroc + Vardenafil Receives: Drug: Maraviroc; Drug: Vardenafil
2.	Placebo comparator	Maraviroc + Placebo Receives: Drug: Maraviroc; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Standing and Supine Systolic and Diastolic Blood Pressure (BP)
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.
Measured: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose

Secondary outcomes (4)

Standing and Supine Pulse Rate
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.
Measured: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose
Postural Changes in Systolic and Diastolic Blood Pressure
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.
Measured: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg
Postural Changes in Pulse Rate
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.
Measured: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg
Number of Subjects With Postural Hypotension
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.
Measured: Period 1 and Period 2 (up to 8 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2008May 2008

First posted2 Mar 2009 (estimated)
Study startApr 2008
Primary completionMay 2008
Study completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AIDSStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00853840
Sponsor's protocol ID: A4001074
Status last verified: Jan 2013
First submitted: 27 Feb 2009
Last updated: 25 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All AIDS trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single-Blinded, Placebo-Controlled Two-Way Crossover Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc
ClinicalTrials.gov ID: NCT00853840
Acronym / sponsor ID: A4001074
Conditions: AIDS
Keywords: pharmacodynamics. maraviroc, vardenafil, blood pressure
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: Apr 2008
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 2 Mar 2009 (estimated)
Results: Posted 23 Jun 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
1.	Experimental	Drug: Maraviroc, Drug: VardenafilMaraviroc + Vardenafil
2.	Placebo comparator	Drug: Maraviroc, Drug: PlaceboMaraviroc + Placebo

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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).

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MaravirocAlso: Celsentri, SelzentryMaraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.	Drug	1.
VardenafilMaraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Vardenafil 20 mg.	Drug	1.
MaravirocAlso: Selzentry, CelsentriMaraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.	Drug	2.
PlaceboMaraviroc 300 mg twice daily for 3 - 4 days plus a single oral dose of Placebo.	Drug	2.

Primary outcome

Standing and Supine Systolic and Diastolic Blood Pressure (BP)
Time frame: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose
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.

4 secondary outcomes

Standing and Supine Pulse Rate
Time frame: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose
Postural Changes in Systolic and Diastolic Blood Pressure
Time frame: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg
Postural Changes in Pulse Rate
Time frame: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg
Number of Subjects With Postural Hypotension
Time frame: Period 1 and Period 2 (up to 8 days)

Results and safety

Results posted to the registry on 23 Jun 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vardenafil + Maraviroc	9	9
Non-matching Placebo + Maraviroc	9	9

Primary outcome: Standing and Supine Systolic and Diastolic Blood Pressure (BP)

Time frame: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose. Least squares mean (Standard Error). Unit: mm Hg

Measure	Maraviroc + Vardenafil (Treatment A) n = 18	Maraviroc + Placebo (Treatment B) n = 18
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)

Maraviroc + Vardenafil (Treatment A) vs Maraviroc + Placebo (Treatment B): Mean Difference (Final Values): -1.11 (90% CI -3.80 to 1.59), Mixed Models Analysis
Maraviroc + Vardenafil (Treatment A) vs Maraviroc + Placebo (Treatment B): Mean Difference (Final Values): -1.93 (90% CI -3.55 to -0.31), Mixed Models Analysis
Maraviroc + Vardenafil (Treatment A) vs Maraviroc + Placebo (Treatment B): Mean Difference (Final Values): -4.99 (90% CI -7.69 to -2.30), Mixed Models Analysis

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Maraviroc Run-In	0 of 18 (0%)	4 of ?	Not reported
Maraviroc + Vardenafil (Treatment A)	0 of 18 (0%)	16 of ?	Not reported
Maraviroc + Placebo (Treatment B)	0 of 18 (0%)	5 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for AIDS

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Maraviroc and Vardenafil in people with AIDS, run by ViiV Healthcare at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standing and Supine Systolic and Diastolic Blood Pressure (BP) (time frame: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00853840.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2013.