Drug-induced HypotensionNCT02626923
Study of Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in ART-Naive & First Switch Patients
An observational study of Drug-induced Hypotension, run by Nicholaos C Bellos, MD.
Trial summary
Hypotension does not occur with Maraviroc at a dose of 600 mg/day Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Drug-induced Hypotension
- Type of treatment
- Pill or oral medicine
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV impacted individual on therapy with once daily Maraviroc
Who may be able to join
- Epzicom Maraviroc once daily dosing
Who cannot join
- Maraviroc with any other back bone
About this study
Official title: Observational Study of the Safety and Efficacy of Nucleoside Reverse Transcriptase Inhibitor Backbones With Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in Antiretroviral Therapy-Naive Patients and First-Switch Subjects
Hypotension does not occur with Maraviroc at a dose of 600 mg/day
Read the detailed description
A qualitative description of orthostatic hypotension in patients receiving once daily Maraviroc at 600 mg with Epzicom measured by a validated questionnaire
- Conditions
- Drug-induced Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients on once daily Maraviroc | Maraviroc tablet 600 mg once daily 48 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypotension related to once daily Maraviroc dosing
Blood pressure lowering secondary to Maraviroc 600 mg once daily dosing
Measured: 48 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study startJul 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-induced HypotensionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicholaos C Bellos, MD
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor-investigator, Nicholaos C Bellos, MD, Southwest Infectious Disease Clinical Research, Inc.
- Investigators
- Nicholaos C Bellos, MD, Study chair, Southwest Infectious Disease, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626923
- Sponsor's protocol ID
- 759-TBC
- Status last verified
- Dec 2015
- First submitted
- 7 Dec 2015
- Last updated
- 10 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of the Safety and Efficacy of Nucleoside Reverse Transcriptase Inhibitor Backbones With Maraviroc (MVC) and Epzicom (ABC/3TC) Once-Daily in Antiretroviral Therapy-Naive Patients and First-Switch Subjects
- ClinicalTrials.gov ID
- NCT02626923
- Acronym / sponsor ID
- 759-TBC
- Conditions
- Drug-induced Hypotension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Nicholaos C Bellos, MDUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypotension does not occur with Maraviroc at a dose of 600 mg/day
Detailed description
A qualitative description of orthostatic hypotension in patients receiving once daily Maraviroc at 600 mg with Epzicom measured by a validated questionnaire
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on once daily Maraviroc | – | –Maraviroc tablet 600 mg once daily 48 weeks |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV impacted individual on therapy with once daily Maraviroc
Key inclusion criteria (1 listed)
- Epzicom Maraviroc once daily dosing
Key exclusion criteria (1 listed)
- Maraviroc with any other back bone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypotension related to once daily Maraviroc dosing
Time frame: 48 Weeks
Blood pressure lowering secondary to Maraviroc 600 mg once daily dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2015.
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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.
Nicholaos C Bellos, MD study chair
Southwest Infectious Disease, PA
Questions about this trial
What is this clinical trial studying?
An observational study of Drug-induced Hypotension, run by Nicholaos C Bellos, MD.
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 1 inclusion and 1 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 10 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hypotension related to once daily Maraviroc dosing (time frame: 48 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2015.