HIV Test and Treat to Prevent HIV Transmission Among MSM and Transgender Women
Condition: HIV
Intervention: Atripla or Stribild
Intervention description: Antiretroviral therapy
Intervention MeSH terms: Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 225.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; Treatment as Prevention; Seek, Test, Treat, Retain Strategies

Summary:

      This study will recruit men and transgender women with acute or recent HIV infection. It wil
      look at how HIV medicines (ART) when given very early after HIV infection affect the amount
      of HIV in the blood, semen and rectal secretions. In addition, Investigators will be using
      modeling studies to look at whether or not this kind of HIV treatment can decrease the risk
      that a man will infect a person he has sex with and to find out how failure to take
      medications will impact spreading the virus to other people.

      In this study, one group will be randomized (like a coin toss) to start ART immediately (just
      at the time of the enrollment visit) and the other group will wait until week 24 of the study
      to start ART. Both groups will be followed for a total of 48 weeks and will continue to
      receive ART from local sources after the study is over.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult men who have sex with men, and transgender women

          -  Unaware of HIV status at enrollment in follow-up cohort

          -  High risk for HIV infection

          -  Willing to test for HIV

          -  No prior ART, including prior administration of pre- and post-exposure prophylaxis in
             the last 30 days

          -  Willing to provide informed consent

        Exclusion Criteria:

          -  Prior receipt of investigational anti-HIV vaccine

          -  Ongoing therapy with any of the following:

               1. Systemic corticosteroids. Short course less than or equal to 21 days of
                  corticosteroids is allowed

               2. Systemic chemotherapeutic agents

               3. Nephrotoxic systemic agents, including aminoglycosides, amphotericin B,
                  cidofovir, cisplatin, foscarnet, pentamidine

               4. Immunomodulatory treatments including Interleukin-2

               5. Investigational agents

          -  Known allergy/sensitivity or any hypersensitivity to components of study drugs (ART)
             or their formulations

          -  Active drug or alcohol use or dependence that would interfere with adherence to study
             requirements

          -  Serious medical or psychiatric illness that would interfere with the ability to adhere
             to study requirements

          -  Chronic or acute hepatitis B infection

          -  Use of female hormonal products based on estrogen or derivatives