Dolutegravir in Reservoirs
Condition: HIV
Intervention: dolutegravir; Triumeq; Truvada
Intervention description: Tivicay is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 50 mg of Tivicay (dolutegravir) will be taken orally once a day.; Triumeq is a fixed-dose combination drug for the treatment of HIV/AIDS. It is a combination of 600 mg abacavir, 50 mg dolutegravir and 300 mg lamivudine. Triumeq will be taken orally once daily.; Truvada is a combination of emtriva and viread, both nucleoside analog HIV-1 reverse transcriptase inhibitors. Truvada is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. One Truvada tablet (containing 200 mg/300 mg of emtricitabine and tenofovir disoproxil fumarate) will be taken orally once daily.
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Dolutegravir; Abacavir, dolutegravir, and lamivudine drug combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out how well the HIV medication dolutegravir gets into
      different parts of the body including blood plasma, special blood cells, and rectal tissue.
      Specifically, investigators want to compare how fast dolutegravir lowers the HIV viral load
      in these three different sites. In addition, as an exploratory aim, investigators seek to
      learn if there are any differences in how dolutegravir acts in males and females. Results of
      this study will provide more information about HIV medications and their limitations. In the
      future, this could help create better HIV medications that can get into these hard-to-reach
      places and eventually cure HIV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  No ARVs in the last 6 months (from date of screening)

          -  No documented or suspected resistance to integrase inhibitors (dolutegravir,
             elvitegravir, raltegravir, or bictegravir).

          -  Creatinine Clearance >50 mL/min, as calculated by the Cockcroft-Gault equation within
             90 days of screen

          -  Liver function testing, including alanine aminotransferase (ALT), aspartate
             aminotransferase (AST), and alkaline phosphatase < 5 times upper limit of normal
             within 90 days of screen

          -  Intact gastrointestinal tract

          -  Able and willing to give informed consent

          -  Willing and eligible to initiate ARV therapy with Triumeq, DTG + Truvada (TDF/FTC), or
             DTG + Descovy (FTC/TAF)

          -  Agree to receive from their provider and pay for a prescribed supply of the drug,
             Tivicay® (dolutegravir/DTG), with either Triumeq, or Truvada or Descovy as determined
             by their primary HIV provider

               -  Agree to take the prescribed medication by mouth

               -  Agree that they (the participant) is responsible for bringing these medications
                  with them to their study visits

          -  Willing to undergo serial blood and rectal tissue sampling

          -  Female participants' must be willing to have a pregnancy test done at each visit.
             Female participants of childbearing potential (FCB) must agree to either commit to
             continued abstinence from heterosexual intercourse or to use a reliable form of birth
             control such as oral contraceptive pills, intrauterine device, Nexplanon, DepoProvera,
             permanent sterilization, or another acceptable method, as determined by the
             investigator for the duration of the study. FCB are defined as sexually mature women
             who have not undergone hysterectomy or bilateral oophorectomy or have not been
             naturally postmenopausal for at least 24 consecutive months (i.e have had menses at
             any time in preceding 24 months)

        Exclusion Criteria:

          -  Pregnant or attempting to conceive now or during the course of the study

          -  Self-reported or documented current anal or rectal disease prohibiting safe anoscopy
             and biopsies, in investigator's opinion.

          -  Taking concurrent medications that interfere with DTG

          -  Bleeding diathesis

          -  Platelet count <50,000 mm3

          -  Medical condition that interferes with conduct of study, in investigator's opinion