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OpenTrials
Completed

NCT Number: NCT03081572

Platelet Function on Abacavir and Tenofovir

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.

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Key information

Conditions

Cardiovascular Diseases Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections HIV/AIDS Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Platelet Aggregation, Spontaneous RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical AIDS Research and Education Center

Los Angeles, California, 90025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • HIV positive
  • Stable antiretroviral regimen for > 3months containing either abacavir or tenofovir
  • Suppressed HIV viral load

Exclusion criteria

  • Current cigarette smoking
  • Pre-existing platelet disorder
  • current or recent (last 6 months) antiplatelet therapy
  • pregnancy

Treatment and study plan

Platelet aggregation

Diagnostic Test

Platelet aggregation

Primary outcomes

  1. Platelet aggregation

    Time frame: At screening visit

    Degree of platelet aggregation in response to adenosine diphosphate

Secondary outcomes

  1. Plasma Markers of coagulation

    Time frame: At screening visit

    sGPVI

  2. Plasma Markers of Coagulation

    Time frame: At screening visit

    sPSelectin

  3. Plasma markers of endothelial function

    Time frame: At screening visit

    sICAM

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Differences in Platelet Function in Patients on Abacavir Versus Tenofovir Based Antiretroviral Regimens

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 16, 2017
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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