Cardiovascular DiseasesNCT03081572
Platelet Function on Abacavir and Tenofovir
An observational study of Cardiovascular Diseases and Platelet Aggregation, Spontaneous, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This is a small observational study aimed at observing differences in platelet function in HIV patients on abacavir versus tenofovir based anti-HIV drugs. There is some correlation between platelet activation and cardiovascular disease- this study will act as a pilot to see if platelet activation among abacavir users… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Platelet Aggregation, Spontaneous, HIV/AIDS
- What is being tested?
- Platelet aggregation
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2018to 15 Feb 2020
- 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: HIV positive non smokers who are on a stable antiretroviral regimen containing either abacavir or tenofovir
Who may be able to join
- HIV positive
- Stable antiretroviral regimen for > 3months containing either abacavir or tenofovir
- Suppressed HIV viral load
Who cannot join
- Current cigarette smoking
- Pre-existing platelet disorder
- current or recent (last 6 months) antiplatelet therapy
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical AIDS Research and Education Center
Los Angeles, California, 90025
About this study
Official title: Differences in Platelet Function in Patients on Abacavir Versus Tenofovir Based Antiretroviral Regimens
This is a small observational study aimed at observing differences in platelet function in HIV patients on abacavir versus tenofovir based anti-HIV drugs. There is some correlation between platelet activation and cardiovascular disease- this study will act as a pilot to see if platelet activation among abacavir users may explain the correlation between abacavir and cardiovascular disease in HIV positive patients.
This study will enroll 44 participants total; 22 on abacavir-based treatment, 22 on tenofovir-based treatment. There is only one study visit which includes a blood draw, physical assessment, and review of medical history.
- Being tested
- Platelet aggregation
- Medical subject headings
- Cardiovascular Diseases, Platelet Aggregation, Spontaneous, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet aggregationDiagnostic test
Platelet aggregation
| Study group | Role | What they receive |
|---|---|---|
| Abacavir Group | HIV positive individuals currently taking an abacavir based regimen Receives: Diagnostic Test: Platelet aggregation | |
| Tenofovir Group | HIV positive individuals currently taking a tenofovir based regime Receives: Diagnostic Test: Platelet aggregation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation
Degree of platelet aggregation in response to adenosine diphosphate
Measured: At screening visit
Secondary outcomes (3)
Plasma Markers of coagulation
sGPVI
Measured: At screening visit
Plasma Markers of Coagulation
sPSelectin
Measured: At screening visit
Plasma markers of endothelial function
sICAM
Measured: At screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start30 Apr 2018
- Primary completion15 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081572
- Sponsor's protocol ID
- 5P30A1028697
- Status last verified
- Nov 2020
- First submitted
- 1 Mar 2017
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Platelet Function in Patients on Abacavir Versus Tenofovir Based Antiretroviral Regimens
- ClinicalTrials.gov ID
- NCT03081572
- Acronym / sponsor ID
- 5P30A1028697
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 30 Apr 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 16 Mar 2017 (actual)
- 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 is a small observational study aimed at observing differences in platelet function in HIV patients on abacavir versus tenofovir based anti-HIV drugs. There is some correlation between platelet activation and cardiovascular disease- this study will act as a pilot to see if platelet activation among abacavir users may explain the correlation between abacavir and cardiovascular disease in HIV positive patients.
This study will enroll 44 participants total; 22 on abacavir-based treatment, 22 on tenofovir-based treatment. There is only one study visit which includes a blood draw, physical assessment, and review of medical history.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abacavir Group | – | Diagnostic Test: Platelet aggregationHIV positive individuals currently taking an abacavir based regimen |
| Tenofovir Group | – | Diagnostic Test: Platelet aggregationHIV positive individuals currently taking a tenofovir based regime |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV positive non smokers who are on a stable antiretroviral regimen containing either abacavir or tenofovir
Key inclusion criteria (3 listed)
- HIV positive
- Stable antiretroviral regimen for > 3months containing either abacavir or tenofovir
- Suppressed HIV viral load
Key exclusion criteria (4 listed)
- Current cigarette smoking
- Pre-existing platelet disorder
- current or recent (last 6 months) antiplatelet therapy
- pregnancy
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 |
|---|---|---|
| Platelet aggregationPlatelet aggregation | Diagnostic test | Abacavir Group, Tenofovir Group |
Primary outcome
Platelet aggregation
Time frame: At screening visit
Degree of platelet aggregation in response to adenosine diphosphate
3 secondary outcomes
Plasma Markers of coagulation
Time frame: At screening visit
Plasma Markers of Coagulation
Time frame: At screening visit
Plasma markers of endothelial function
Time frame: At screening visit
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 19 Nov 2020.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cardiovascular Diseases and Platelet Aggregation, Spontaneous, run by University of California, Los Angeles 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 3 inclusion and 4 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 19 Nov 2020. 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?
Platelet aggregation (time frame: At screening visit). 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 19 Nov 2020.