Acquired Immunodeficiency SyndromeHOSTNCT02322827
Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed HAART
An observational study of Acquired Immunodeficiency Syndrome and Human Immunodeficiency Virus Type, run by Olayemi Osiyemi MD at 1 site in United States.
Trial summary
This study is designed to see how HIV infected patients perform when taking a single fixed dose HIV medication compared to a regimen with multiple tablets. The study is also going to be looking at the differences in complications between the two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, Human Immunodeficiency Virus Type
- Type of treatment
- Pill or oral medicine
- How many people
- 445 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Oct 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are HIV infected and taking antiretroviral therapy
Who may be able to join
- Male or Female (gender at birth), age 18 years or older
- Documented HIV-1 infection by western blot or HIV viral load
- Prescribed antiretroviral therapy, either STR (single tablet regime) or MTR (multi tablet regimen) for at least 6 months
- Patients should have a minimum of 3 office visits
Who cannot join
- Patients who were evaluated in the hospital but never came to the clinic
Trial locations and contacts
1 site in 1 country.
United States1 site
Triple O Research Institute PA
West Palm Beach, Florida, 33401
About this study
Official title: Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed a Single Tablet Regimen (STR) Versus Multi Tablet Regimen (MTR).
This study is designed to see how HIV infected patients perform when taking a single fixed dose HIV medication compared to a regimen with multiple tablets. The study is also going to be looking at the differences in complications between the two groups.
Read the detailed description
This is a phase IV retrospective chart review of HIV infected patients in a private Infectious disease practice in West Palm Beach, FL. This chart review will assign patients into one of two groups based on their antiretroviral regimen: single tablet regimen (STR) versus multi tablet regimen (MTR). Up to 650 patient charts will be reviewed but only about 500 patients are needed for statistical analysis.
The primary objective is to look at the proportion of patients with an adherence rate greater than or equal to 95% in subjects prescribed STR versus a MTR.
Secondary Objectives:
- Differences in emergency room visits, hospitalization and readmission in patients taking a STR vs. a MTR
- Proportion of patients with HIV viral load less than 50copies/microliter
- Incidence of new onset or worsening hyperlipidemia in patients taking a STR versus a MTR
- Incidence of acute renal insufficiency
- Compare the absolute CD4 number increase between a STR and a MTR
- Compare monthly copay amounts in patients taking a STR versus a MTR
- Identify the incidence of opportunistic infections in patients taking a STR versus a MTR
- Keywords
- hiv/aids
- 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.
| Study group | Role | What they receive |
|---|---|---|
| single tablet regimen | Subjects whose most recent antiretroviral therapy consist of a single tablet regimen | |
| multiple tablet regimen | Subjects whose most recent antiretroviral therapy consist of multi tablet regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the proportion of patients with an adherence rate greater than or equal to 95% in subjects taking a STR versus a MTR
Measured: 1 year
Secondary outcomes (7)
compare differences in ER visits, hospitalizations and readmissions in patients taking a STR versus a MTR
composite
Measured: 2 years
Compare proportion of subjects with viral load less than 50 copies/microL
Measured: 1year
Identify the incidence of new onset or worsening hyperlipidemia in subjects taking a TR versus a MTR
Measured: 2 years
Identify the incidence of acute renal insufficiency in subjects taking a STR versus a MTR
Measured: 2 years
Compare the absolute CD4 number increase between a STR and a MTR
Measured: 1 year
Compare monthly copay amounts in patients prescribed STR and MTR
Measured: 1 year
Identify the incidence of opportunistic infections in subjects taking a STR versus a MTR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies 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
- Time perspective
- Retrospective
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olayemi Osiyemi MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Olayemi Osiyemi MD, Triple O Research Institute PA
- Investigators
- Olayemi Osiyemi, M.D., Principal investigator, Triple O Research Institute PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02322827
- Sponsor's protocol ID
- IN-US-236-1642
- Acronym
- HOST
- Status last verified
- Oct 2016
- First submitted
- 25 Nov 2014
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence & Health Outcome Differences Amongst HIV Infected Patients Prescribed a Single Tablet Regimen (STR) Versus Multi Tablet Regimen (MTR).
- ClinicalTrials.gov ID
- NCT02322827
- Acronym / sponsor ID
- HOST / IN-US-236-1642
- Keywords
- hiv/aids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Olayemi Osiyemi MDUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Dec 2014 (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.
This study is designed to see how HIV infected patients perform when taking a single fixed dose HIV medication compared to a regimen with multiple tablets. The study is also going to be looking at the differences in complications between the two groups.
Detailed description
This is a phase IV retrospective chart review of HIV infected patients in a private Infectious disease practice in West Palm Beach, FL. This chart review will assign patients into one of two groups based on their antiretroviral regimen: single tablet regimen (STR) versus multi tablet regimen (MTR). Up to 650 patient charts will be reviewed but only about 500 patients are needed for statistical analysis.
The primary objective is to look at the proportion of patients with an adherence rate greater than or equal to 95% in subjects prescribed STR versus a MTR.
Secondary Objectives:
- Differences in emergency room visits, hospitalization and readmission in patients taking a STR vs. a MTR
- Proportion of patients with HIV viral load less than 50copies/microliter
- Incidence of new onset or worsening hyperlipidemia in patients taking a STR versus a MTR
- Incidence of acute renal insufficiency
- Compare the absolute CD4 number increase between a STR and a MTR
- Compare monthly copay amounts in patients taking a STR versus a MTR
- Identify the incidence of opportunistic infections in patients taking a STR versus a MTR
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single tablet regimen | – | –Subjects whose most recent antiretroviral therapy consist of a single tablet regimen |
| multiple tablet regimen | – | –Subjects whose most recent antiretroviral therapy consist of multi tablet regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are HIV infected and taking antiretroviral therapy
Key inclusion criteria (4 listed)
- Male or Female (gender at birth), age 18 years or older
- Documented HIV-1 infection by western blot or HIV viral load
- Prescribed antiretroviral therapy, either STR (single tablet regime) or MTR (multi tablet regimen) for at least 6 months
- Patients should have a minimum of 3 office visits
Key exclusion criteria (1 listed)
- Patients who were evaluated in the hospital but never came to the clinic
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
Compare the proportion of patients with an adherence rate greater than or equal to 95% in subjects taking a STR versus a MTR
Time frame: 1 year
7 secondary outcomes
compare differences in ER visits, hospitalizations and readmissions in patients taking a STR versus a MTR
Time frame: 2 years
Compare proportion of subjects with viral load less than 50 copies/microL
Time frame: 1year
Identify the incidence of new onset or worsening hyperlipidemia in subjects taking a TR versus a MTR
Time frame: 2 years
Identify the incidence of acute renal insufficiency in subjects taking a STR versus a MTR
Time frame: 2 years
Compare the absolute CD4 number increase between a STR and a MTR
Time frame: 1 year
Compare monthly copay amounts in patients prescribed STR and MTR
Time frame: 1 year
Identify the incidence of opportunistic infections in subjects taking a STR versus a MTR
Time frame: 2 years
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 28 Oct 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Acquired Immunodeficiency Syndrome
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.
Olayemi Osiyemi, M.D. principal investigator
Triple O Research Institute PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Immunodeficiency Syndrome and Human Immunodeficiency Virus Type, run by Olayemi Osiyemi MD at 1 site in United States.
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 4 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 28 Oct 2016. 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 United States. 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. 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?
Compare the proportion of patients with an adherence rate greater than or equal to 95% in subjects taking a STR versus a MTR (time frame: 1 year). 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 28 Oct 2016.