Comparison of Virologic and Immunologic Responses to Raltegravir and Dolutegravir in the Gastrointestinal Tract of HIV-Positive Adults
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Observational

Summary: 
      This is a Phase IV, open label, observational study to compare the gastrointestinal tissue
      concentrations, inflammatory response, and viral replication of two integrase-inhibitors,
      raltegravir and dolutegravir, in HIV-infected volunteers who are virologically suppressed in
      blood plasma. The study will be comprised of 20 HIV-infected volunteers who will be enrolled
      equally into two groups. Group A will consist of 10 subjects receiving an antiretroviral
      regimen of tenofovir, emtricitabine, and raltegravir, and Group B will consist of 10 subjects
      receiving an antiretroviral regimen of tenofovir, emtricitabine, and dolutegravir.
      Participants will provide small pieces of tissue, or biopsies, which will be taken from three
      distinct locations of the large intestine during a colonoscopy procedure. These biopsies will
      be used to measure the amount of raltegravir or dolutegravir, HIV virus, and inflammatory
      markers present in the gastrointestinal tract.
    

Detailed description: 
      Purpose: To compare virologic and immunologic responses to raltegravir and dolutegravir in
      the gastrointestinal tract of HIV-positive men and women

      Participants: Twenty HIV-infected volunteers will be enrolled equally into two groups. Group
      A will consist of subjects receiving an antiretroviral regimen of raltegravir, tenofovir, and
      emtricitabine and Group B will consist of subjects receiving an antiretroviral regimen of
      dolutegravir, tenofovir, and emtricitabine.

      Procedures (methods): This is a Phase IV, open label study to compare the gastrointestinal
      tissue concentrations, cytokine response, and viral replication in gut-associated lymphoid
      tissue of two integrase-inhibitors in HIV-infected volunteers who are virologically
      suppressed in blood plasma. Subjects will undergo an observed bowel preparation, followed by
      a colonoscopy in which tissue will be obtained by a board-certified gastroenterologist from
      the terminal ileum/ascending colon, splenic flexture, and rectum/sigmoid colon. Blood plasma
      will be collected immediately prior to collection of tissue samples.
    

Intervention name(s): Raltegravir; Dolutegravir; Colonoscopy with biopsy
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): This procedure is not standard of care for patients receiving combination antiretroviral therapy (cART), but is necessary to obtain tissue samples.
Other intervention name(s): Isentress ®; Tivicay ®
Intervention MeSH terms: Raltegravir Potassium; Dolutegravir
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from University of North Carolina Infectious Diseases Clinic.
      
Keywords: HIV; Gut-associated lymphoid tissue; raltegravir; Isentress; dolutegravir; Tivicay; pharmacodynamics