FTC/RPV/TDF on T-Cell Activation, CD4+ T-Cell Count, Inflammatory Biomarkers and Viral Reservoir
Condition: HIV-1 Infection
Intervention: Emtricitabine/rilpivirine/tenofovir disoproxil fumarate
Intervention description: Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment.
Intervention MeSH terms: Tenofovir; Emtricitabine; Rilpivirine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study was done with people who were infected with HIV, but did not show any signs of
      having HIV. They were also feeling well without taking HIV medication and had low or
      undetectable levels of the virus in the blood. The purpose of this study was to see if taking
      HIV medication (antiretroviral therapy [ART]) would reduce immune activation (a signal that
      the body is fighting an infection) in people who have HIV, but did not show symptoms. Also
      this study helped determine how safe the drug was and how well people reacted to the drug.

      For this study, the following antiretroviral therapy (ART) was be provided in the form of a
      single tablet that contains three different drugs: emtricitabine/rilpivirine/tenofovir
      disoproxil fumarate (FTC/RPV/TDF). These drugs were combined as one tablet which was approved
      by the Food and Drug Administration (FDA) as a single pill to treat HIV infection. The HIV
      medication provided was one of the recommended treatments for HIV, including people with low
      viral loads (how much HIV you have in your body) who were taking HIV drugs for the first
      time. The risks seen with this HIV medication were the same that one would encounter when
      taking these drugs outside of the study.
    

Eligibility criteria:

        Inclusion Criteria:

        Step 1

          -  HIV-1 infection

          -  ART-naïve defined as ≤7 days of antiretroviral (ARV) treatment at any time prior to
             entry

          -  Documentation of HIV-1 RNA <500 copies/mL verified by at least two measurements prior
             to the screening RNA specimen

          -  Screening HIV-1 RNA <500 copies/mL using an US FDA-approved assay obtained within 60
             days prior to study entry by any laboratory that has a CLIA certification or its
             equivalent

          -  Laboratory values obtained within 60 days prior to entry by any laboratory that has a
             CLIA certification or its equivalent:

               -  Absolute neutrophil count (ANC) >=500/mm^3

               -  Hemoglobin >=8.0 g/dL

               -  Platelet count >=40,000/mm^3

               -  Aspartate aminotransferase (AST) (SGOT), alanine aminotransferase (ALT) (SGPT),
                  and alkaline phosphatase <=5 X Upper Limit of Normal (ULN)

               -  Total bilirubin <=2.5 X ULN

               -  Calculated creatinine clearance (CrCl) >=60 mL/min

          -  For females of reproductive potential, negative serum or urine pregnancy test within
             48 hours prior to study entry by any clinic or laboratory that has a CLIA
             certification or its equivalent

          -  Female subjects of reproductive potential, who are participating in sexual activity
             that could lead to pregnancy, must agree to use at least one reliable form of
             contraceptive (ie, condoms (male or female) with or without a spermicidal agent; a
             diaphragm or cervical cap with spermicide; an intrauterine device (IUD); or
             hormone-based contraceptive) while receiving the protocol-specified treatment and for
             6 weeks after stopping the medications

          -  No evidence of any exclusionary resistance mutations based on results from any
             genotype assay from any laboratory that has a Clinical Laboratory Improvement
             Amendments (CLIA) certification or its equivalent

        Step 2

          -  Completion of Step 1

          -  Ability and willingness of subject to choose to receive either open-label ART FDC
             (FTC/RPV/TDF) or no study treatment for an additional 48 weeks

          -  For females of reproductive potential, negative serum or urine pregnancy test within
             48 hours prior to the week 60 visit by any clinic or laboratory that has a CLIA
             certification or its equivalent

        Exclusion Criteria:

        Step 1

          -  Chronic hepatitis B virus (HBV) infection (documented by hepatitis B surface antigen
             (HBsAg) seropositivity)

          -  Breastfeeding

          -  Use of immunomodulators (eg, interleukins, interferons, cyclosporine), topical
             imiquimod, HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy
             within 30 days prior to study entry or plans to start immunomodulators, topical
             imiquimod, HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy
             during the study

          -  Known allergy/sensitivity or any hypersensitivity to components of study drug(s) or
             their formulation

          -  Active drug or alcohol use or dependence that, in the opinion of the site
             investigator, would interfere with adherence to study requirements

          -  Acute or serious illness requiring systemic treatment and/or hospitalization within 30
             days prior to entry

          -  Symptomatic HIV disease and/or AIDS-defining illness.

          -  Vaccinations within 7 days prior to study entry

          -  Plans to initiate hepatitis C treatment during the study

          -  Perinatally-acquired HIV

          -  Use of any of the following medications within 7 days prior to study entry:

               -  St. John's wort (Hypercium perforatum)

               -  Anticonvulsants (eg, oxacarbazepine, phenobarbital, phenytoin)

               -  Anti-infectives (eg, rifabutin, rifampin, rifapentine)

               -  Corticosteroids (eg, dexamethasone (more than 1 dose))

               -  Proton pump inhibitors (eg, esomeprazole, lansoprazole, omeprazole, pantoprazole,
                  rabeprazole)

        Step 2

          -  Plans to start immunomodulators, topical imiquimod, HIV vaccine, systemic cytotoxic
             chemotherapy, or investigational therapy during Step 2 of the study

          -  Plans to initiate hepatitis C treatment during Step 2 of the study

        NOTE: Please refer to the protocol for detailed eligibility criteria.