Early ART to Limit Infection and Establishment of Reservoir
Condition: HIV-1 Infection
MeSH terms: Infections; Communicable Diseases
Intervention: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
Intervention description: Participants received one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food or one tablet of bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg by mouth daily with or without food. Other non-study-provided ARV regimens were allowed for participants who were pregnant, breastfeeding, or unable/unwilling to take EVG/COBI/FTC/TAF or BIC/FTC/TAF, or for participants whose local health care/primary care provider preferred starting a different initial ARV regimen.
Intervention MeSH terms: Tenofovir; Emtricitabine; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Cobicistat; Emtricitabine tenofovir alafenamide; Elvitegravir; Anti-Retroviral Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The study was done to:

        -  Start antiretroviral therapy (ART) early in those recently or acutely infected with
           HIV-1

        -  See how starting ART as soon as the infection is found affects the amount of HIV-1 in
           blood and how well the body fights the HIV-1 infection

        -  Look at the amount of HIV-1 DNA (genetic material for HIV-1) seen in CD4+ T-cells
           (infection-fighting cells in blood) after 48 weeks of ART

        -  See how early treatment for HIV affects the numbers of HIV-1 infection fighting cells
           (CD4+ and CD8+ T-cells) in blood
    

Eligibility criteria:

        Inclusion Criteria:

        Appropriate documentation from medical records of diagnosis of acute HIV-1 infection (AHI)
        within 7 days prior to enrollment, that includes one of the following:

          1. A detectable HIV-1 RNA within 28 days prior to study entry AND a non-reactive HIV-1
             antibody within 7 days prior to entry OR

          2. A detectable HIV-1 RNA or a reactive HIV-1 antibody within 28 days prior to study
             entry AND a negative/indeterminate WB or negative/indeterminate Geenius HIV-1/HIV-2
             Supplemental Assay within 7 days prior to entry OR

          3. A documented non-reactive HIV-1 antibody or negative HIV-1 RNA within 90 days prior to
             study entry AND a documented reactive HIV-1 antibody or positive WB that is negative
             for p31 band or a positive Geenius HIV-1/HIV-2 Supplemental Assay that is negative for
             p31 band within 7 days prior to entry OR

          4. ARCHITECT or GSCOMBO S/CO ≥10 within 7 days prior to entry AND a non-reactive HIV-1
             antibody within 7 days prior to entry OR

          5. ARCHITECT or GSCOMBO S/CO ≥1 within 7 days prior to entry AND a non-reactive HIV-1
             antibody within 7 days prior to entry AND a known prior S/CO <0.5 within 90 days prior
             to entry OR

          6. ARCHITECT or GSCOMBO S/CO >0.5 but <10 within 7 days prior to entry AND a non-reactive
             HIV-1 antibody within 7 days prior to entry AND detectable HIV-1 RNA within 7 days
             prior to entry

        Note A: HIV-1 RNA result must be reported from an FDA-approved or CE-marked assay.

        Note B: Since characterization of Fiebig stage using samples at the time of ART initiation
        was performed with results known within 12 weeks based on standardized, centralized
        testing, an estimated Fiebig group at enrollment based on inclusion criteria as shown in
        the table above will provide additional real-time monitoring for accruals into each study
        group.

          -  Ability and willingness of candidate to provide written informed consent.

          -  Ability and willingness to initiate ART at enrollment.

          -  Ability and willingness to participate in scheduled study visits for up to 72 weeks.

          -  Female candidates of reproductive potential who are not pregnant at the time of
             enrollment and who will receive the study-provided EVG/COBI/FTC/TAF and must agree not
             to participate in the conception process (ie, active attempt to become pregnant, in
             vitro fertilization), and if participating in sexual activity that could lead to
             pregnancy, the female candidate must agree to use at least one reliable form of
             contraceptive while receiving study-provided treatment.

        Female candidates are considered to be of reproductive potential if any of the following
        conditions apply:

          -  Candidate has experienced menarche.

          -  Candidate has not undergone bilateral tubal ligation, bilateral oophorectomy, or
             hysterectomy.

          -  Candidate has not experienced menopause, defined as lack of menstruation within the
             preceding 12 months.

        Acceptable contraceptive methods include:

          -  Condoms (male or female) with or without a spermicidal agent

          -  Diaphragm or cervical cap with spermicide

          -  Intrauterine device

          -  Hormonal contraceptive

        Female candidates who are not of reproductive potential or whose male partner(s) has
        documented azoospermia are not required to use contraceptives. Any statement of
        self-reported sterility or that of her partner must be entered in the source documents.

        NOTE: Acceptable documentation of lack of reproductive potential is oral or written
        documentation from the individual.

        Female candidates who are prescribed a non-study-provided ARV regimen should discuss the
        safety of that regimen during conception and pregnancy with the prescribing physician. Such
        individuals should follow medical guidance regarding any potential need for contraception
        while using the non-study-provided ARV regimen.

        Note: Pregnant and breastfeeding women may enroll in the study provided that they meet the
        eligibility requirements and have access to non-study-provided ARV regimens.

        Exclusion Criteria:

          -  Positive HIV-1 antibody test ≥90 days prior to study entry.

          -  Active drug or alcohol use or dependence that, in the opinion of the site
             investigator, would interfere with adherence to study requirements.

          -  Any acute, chronic, or recent and clinically significant medical condition that, in
             the opinion of the site investigator, would interfere with adherence to study
             requirements or jeopardize the safety or rights of the participant.

          -  Receipt of an investigational study agent within 28 days prior to enrollment

          -  Chronic or recurrent use of medications that modify host immune response, eg, oral or
             parenteral steroids, cancer chemotherapy.

          -  AHI diagnosis within 60 days after receiving any investigational ARV or HIV-1 vaccine
             or immune prophylaxis for HIV-1 infection.

          -  Use of ARVs for pre- or post-exposure prophylaxis within 60 days prior to the
             diagnosis of AHI.