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EARLIER: Early ART to Limit Infection and Establishment of Reservoir

Sponsor
AIDS Clinical Trials Group (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02859558
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
195
Enrollment
30
Locations
3
Arms
80.2
Anticipated Duration (Months)
6.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
 Phase 2

Detailed Description

This was a Phase II, prospective, open-label two-step study to measure the effects of early ART on the establishment of HIV-1 reservoir and HIV-1-specific immunity. Participants were enrolled if they fulfilled the inclusion criteria for acute HIV-1 infection (AHI) diagnosis within 7 days prior to entry and had an enrollment visit with the immediate initiation of ART. Plasma and serum samples for Fiebig staging were collected at the time of ART initiation.

Participants were followed for up to 216 weeks (72 weeks on Step 1 and 144 weeks on Step 2). Evaluations at weeks 2 and 8 on Step 1 were performed via telephone.

The Fiebig stage-classification system was used to characterize the progression from HIV-1 exposure to HIV-1 seroconversion at the time of ART initiation. In this study, the five Fiebig stages of interest were simplified into three study groups as described below (based on HIV-1 antibody diagnostic profile at time of ART initiation).

The primary analysis was based on Step 1. Step 2 was added to the study for long term follow-up. The rationale for the extended follow-up period was to expand the number of available participants for future therapeutic and cure studies without the burden of frequent visits and the cost of study-provided laboratory testing.

Group 1: Fiebig I/II (non-reactive HIV-1 antibody)

Group 2: Fiebig III/IV (reactive HIV-1 antibody and negative or indeterminate results on the Western Blot (WB) or Geenius HIV-1/HIV-2)

Group 3: Fiebig V (reactive HIV-1 antibody and positive WB or Geenius HIV-1/HIV-2 without p31 band)

Although participants in Fiebig VI (positive WB or Geenius HIV-1/HIV-2 with p31 band) were not specifically targeted for enrollment in this study, it was possible that a small number of participants would be determined to be in Fiebig VI (positive Western blot or Geenius HIV-1/HIV-2 with p31 band) based on analysis of the entry samples. Participants who were determined to be in Fiebig VI were followed on the study for no more than 24 weeks on Step 1, allowing ample time for them to pursue alternative sources for ART. Enrolled participants without HIV or in Fiebig VI were replaced.

The study-provided regimen was single tablet regimen elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (EVG/COBI/FTC/TAF) or bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Other non-study-provided antiretroviral (ARV) regimens were also 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
195 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Antiretroviral Treatment Initiated During Acute HIV-1 Infection on Measures of HIV-1 Persistence and on HIV-1-Specific Immune Responses
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Dec 2, 2020
Anticipated Study Completion Date :
Sep 8, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Fiebig I/II

Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody).

Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
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.
Other Names:
  • Single-tablet regimen EVG/COBI/FTC/TAF or Genvoya
  • Single-tablet regimen BIC/FTC/TAF or Biktarvy

    		•
    Experimental: Arm 2: Fiebig III/IV

    Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2).

    Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
    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.
    Other Names:
  • Single-tablet regimen EVG/COBI/FTC/TAF or Genvoya
  • Single-tablet regimen BIC/FTC/TAF or Biktarvy

    		•
    Experimental: Arm 3: Fiebig V

    Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band).

    Drug: elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy
    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.
    Other Names:
  • Single-tablet regimen EVG/COBI/FTC/TAF or Genvoya
  • Single-tablet regimen BIC/FTC/TAF or Biktarvy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) [At week 48]

      Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.

    Secondary Outcome Measures

    1. HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry [At week 48]

      Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)

    2. HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry [At 48 weeks]

      Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)

    3. Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation [At week 0]

      Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 31788 Alabama CRS Birmingham Alabama United States 35294
    2 Ucsd, Avrc Crs (701) San Diego California United States 92103
    3 Harbor-UCLA Med. Ctr. CRS (603) Torrance California United States 90502
    4 Whitman Walker Health CRS (31791) Washington District of Columbia United States 20009
    5 The Ponce de Leon Center CRS (5802) Atlanta Georgia United States 30308
    6 Northwestern University CRS (2701) Chicago Illinois United States 60611
    7 Rush Univ. Med. Ctr. ACTG CRS (2702) Chicago Illinois United States 60612
    8 Massachusetts General Hospital ACTG CRS (101) Boston Massachusetts United States 02114
    9 Brigham and Women's Hosp. ACTG CRS (107) Boston Massachusetts United States 02115
    10 Washington University CRS (2101) Saint Louis Missouri United States 63110
    11 31786 New Jersey Medical School Clinical Research Center CRS Newark New Jersey United States 07103
    12 7804 Weill Cornell Chelsea CRS New York New York United States 10010
    13 Columbia Physicians and Surgeons CRS (30329) New York New York United States 10032
    14 3201 Chapel Hill CRS Chapel Hill North Carolina United States 27516
    15 Greensboro CRS (3203) Greensboro North Carolina United States 27401
    16 Univ. of Cincinnati CRS (2401) Cincinnati Ohio United States 45267
    17 The Ohio State Univ. AIDS CRS (2301) Columbus Ohio United States 43210
    18 6201 Penn Therapeutics CRS Philadelphia Pennsylvania United States 19104
    19 Pittsburgh CRS (1001) Pittsburgh Pennsylvania United States 15213
    20 The Miriam Hosp. ACTG CRS (2951) Providence Rhode Island United States 02906
    21 31443 Trinity Health and Wellness Center CRS Dallas Texas United States 75208
    22 31473 Houston AIDS Research Team (HART) CRS Houston Texas United States 77030
    23 University of Washington AIDS CRS (1401) Seattle Washington United States 98104
    24 Hospital Nossa Senhora da Conceicao CRS (12201) Porto Alegre RS Brazil 9043010
    25 Instituto de Pesquisa Clinica Evandro Chagas (12101) Rio de Janeiro Brazil 21045
    26 Malawi CRS (12001) Lilongwe Malawi
    27 San Miguel CRS (11302) San Isidro Lima Peru
    28 Barranco CRS Lima Peru 18
    29 31802 Thai Red Cross AIDS Research Center Treatment (TRC-ARC Treatment) CRS Bangkok Patumwan Thailand 10330
    30 Milton Park CRS (30313) Harare Zimbabwe

    Sponsors and Collaborators

    • AIDS Clinical Trials Group
    • National Institute of Allergy and Infectious Diseases (NIAID)

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    AIDS Clinical Trials Group
    ClinicalTrials.gov Identifier:
    NCT02859558
    Other Study ID Numbers:
    • ACTG A5354
    • 2UM1AI068636
    First Posted:
    Aug 9, 2016
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Tenofovir
    Emtricitabine
    Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
    Cobicistat
    Emtricitabine tenofovir alafenamide
    Elvitegravir
    Anti-Retroviral Agents

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled from January 2017 to December 2019 at 30 sites in Brazil, Malawi, Peru, Thailand, United States, and Zimbabwe.
    Pre-assignment Detail There was no randomization in this study. Participants who were determined to be in Fiebig VI were followed on the study for no more than 24 weeks on Step 1. Confirmed Fiebig VI and HIV negative participants were replaced.
    Arm/Group Title Arm 1: Fiebig I/II Arm 2: Fiebig III/IV Arm 3: Fiebig V Fiebig VI HIV-negative
    Arm/Group Description Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
    Period Title: Step 1
    STARTED 49 79 60 4 3
    Completed Week 48 41 68 50 0 0
    COMPLETED 37 67 49 4 0
    NOT COMPLETED 12 12 11 0 3
    Period Title: Step 1
    STARTED 25 39 21 0 0
    COMPLETED 0 0 0 0 0
    NOT COMPLETED 25 39 21 0 0

    Baseline Characteristics

    Arm/Group Title Arm 1: Fiebig I/II Arm 2: Fiebig III/IV Arm 3: Fiebig V Fiebig VI HIV-negative Total
    Arm/Group Description Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment. Total of all reporting groups
    Overall Participants 49 79 60 4 3 195
    Age (years) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [years]
    26
    30
    26
    36
    25
    27
    Age, Customized (Count of Participants)
    18-29 years
    31
    63.3%
    39
    49.4%
    36
    60%
    2
    50%
    2
    66.7%
    110
    56.4%
    30-39 years
    12
    24.5%
    18
    22.8%
    12
    20%
    0
    0%
    1
    33.3%
    43
    22.1%
    40-49 years
    4
    8.2%
    12
    15.2%
    6
    10%
    2
    50%
    0
    0%
    24
    12.3%
    50+ years
    2
    4.1%
    10
    12.7%
    6
    10%
    0
    0%
    0
    0%
    18
    9.2%
    Sex/Gender, Customized (Count of Participants)
    Cisgender
    47
    95.9%
    73
    92.4%
    60
    100%
    4
    100%
    2
    66.7%
    186
    95.4%
    Transgender Spectrum
    1
    2%
    5
    6.3%
    0
    0%
    0
    0%
    0
    0%
    6
    3.1%
    Not Reported
    1
    2%
    1
    1.3%
    0
    0%
    0
    0%
    1
    33.3%
    3
    1.5%
    Sex: Female, Male (Count of Participants)
    Female
    4
    8.2%
    12
    15.2%
    11
    18.3%
    2
    50%
    1
    33.3%
    30
    15.4%
    Male
    45
    91.8%
    67
    84.8%
    49
    81.7%
    2
    50%
    2
    66.7%
    165
    84.6%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    17
    34.7%
    30
    38%
    18
    30%
    1
    25%
    2
    66.7%
    68
    34.9%
    Not Hispanic or Latino
    32
    65.3%
    48
    60.8%
    42
    70%
    3
    75%
    1
    33.3%
    126
    64.6%
    Unknown or Not Reported
    0
    0%
    1
    1.3%
    0
    0%
    0
    0%
    0
    0%
    1
    0.5%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    12
    24.5%
    1
    1.3%
    1
    1.7%
    0
    0%
    0
    0%
    14
    7.2%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    19
    38.8%
    35
    44.3%
    39
    65%
    3
    75%
    1
    33.3%
    97
    49.7%
    White
    14
    28.6%
    36
    45.6%
    16
    26.7%
    0
    0%
    0
    0%
    66
    33.8%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    1
    25%
    0
    0%
    1
    0.5%
    Unknown or Not Reported
    4
    8.2%
    7
    8.9%
    4
    6.7%
    0
    0%
    2
    66.7%
    17
    8.7%
    Region of Enrollment (Count of Participants)
    United States
    25
    51%
    65
    82.3%
    42
    70%
    1
    25%
    0
    0%
    133
    68.2%
    Malawi
    4
    8.2%
    3
    3.8%
    3
    5%
    0
    0%
    1
    33.3%
    11
    5.6%
    Brazil
    6
    12.2%
    10
    12.7%
    8
    13.3%
    1
    25%
    0
    0%
    25
    12.8%
    Zimbabwe
    0
    0%
    0
    0%
    6
    10%
    2
    50%
    0
    0%
    8
    4.1%
    Thailand
    12
    24.5%
    1
    1.3%
    0
    0%
    0
    0%
    0
    0%
    13
    6.7%
    Peru
    2
    4.1%
    0
    0%
    1
    1.7%
    0
    0%
    2
    66.7%
    5
    2.6%
    BMI (kg/m^2) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [kg/m^2]
    22.5
    25.9
    23.8
    22.7
    23.2
    24.0
    HIV-1 RNA (log10 copies per mL) (log10(copies per mL)) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [log10(copies per mL)]
    6.4
    6.5
    5.4
    5.0
    1.6
    6.2
    HIV-1 RNA (Count of Participants)
    <40 copies per mL
    0
    0%
    0
    0%
    1
    1.7%
    1
    25%
    3
    100%
    5
    2.6%
    40 - <1000 copies per mL
    1
    2%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    1
    0.5%
    1000 - <10,000 copies per mL
    0
    0%
    2
    2.5%
    6
    10%
    0
    0%
    0
    0%
    8
    4.1%
    10,000 - <100,000 copies per mL
    9
    18.4%
    4
    5.1%
    10
    16.7%
    1
    25%
    0
    0%
    24
    12.3%
    100,000 - <1,000,000 copies per mL
    9
    18.4%
    13
    16.5%
    23
    38.3%
    1
    25%
    0
    0%
    46
    23.6%
    1,000,000 - <10,000,000 copies per mL
    17
    34.7%
    39
    49.4%
    16
    26.7%
    0
    0%
    0
    0%
    72
    36.9%
    >= 10,000,000 copies per mL
    13
    26.5%
    21
    26.6%
    4
    6.7%
    1
    25%
    0
    0%
    39
    20%
    CD4 Count (cells per mm^3) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [cells per mm^3]
    348
    383
    490
    436
    1090
    406
    CD8 Count (cells per mm^3) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [cells per mm^3]
    322
    544
    1016
    1401
    474
    613
    Cell-associated HIV-1 DNA (copies per 5 million CD4+ T-cells) [Median (Inter-Quartile Range) ]
    Integrase Assay
    7739
    15440
    10104
    4575
    0
    10507
    Gag Assay
    4455
    6357
    5388
    3990
    0
    5586

    Outcome Measures

    1. Primary Outcome
    Title Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD)
    Description Proportion of participants with 0 copies of CAHD per 5 million CD4+ blood-derived CD4+ T-cells (assayed by quantitative polymerase chain reaction [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
    Time Frame At week 48

    Outcome Measure Data

    Analysis Population Description
    Participants who maintained HIV-1 RNA<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA >200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA <50 copies/mL ), had available CAHD results from week 48 or week 49, and were enrolled during Fiebig Stage I-V.
    Arm/Group Title Arm 1: Fiebig I/II Arm 2: Fiebig III/IV Arm 3: Fiebig V
    Arm/Group Description Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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.
    Measure Participants 40 64 50
    Joint Assay (Integrase + Gag)
    0.00
    0%
    0.00
    0%
    0.00
    0%
    Integrase Assay
    0.10
    0.2%
    0.06
    0.1%
    0.10
    0.2%
    Gag Assay
    0.03
    0.1%
    0.02
    0%
    0.00
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.48
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.50
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.44
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    2. Secondary Outcome
    Title HIV-1-specific CD4+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
    Description Percent of HIV-1-specific CD4+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)
    Time Frame At week 48

    Outcome Measure Data

    Analysis Population Description
    Participants who maintained HIV-1 RNA<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA >200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA <50 copies/mL ), had available CAHD results from week 48 or week 49, had available immunology marker results where active control result is greater than or equal to the media control, and were enrolled during Fiebig Stage I-V.
    Arm/Group Title Arm 1: Fiebig I/II Arm 2: Fiebig III/IV Arm 3: Fiebig V
    Arm/Group Description Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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.
    Measure Participants 37 60 46
    CD4+ T-cell Response to Env
    0.00
    0.00
    0.08
    CD4+ T-cell Response to Gag
    0.06
    0.19
    0.14
    CD4+ T-cell Response to Nef
    0.04
    0.10
    0.10
    CD4+ T-cell Response to Pol
    0.00
    0.04
    0.04
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.39
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.46
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.056
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.025
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.072
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.47
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.086
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.18
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.88
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.061
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.042
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD4+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.54
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    3. Secondary Outcome
    Title HIV-1-specific CD8+ and T-cell Responses to Nef, Gag, Pol and Env by Flow Cytometry
    Description Percent of HIV-1-specific CD8+ T-cells expressing any cytokine/marker (CD40L, CD107a, IFNg, MIP1B, TNFa) to each of the 4 protein stimulants (nef, gag, pol and env) by flow cytometry while HIV-1 RNA is suppressed on ART. The results for a specific participant are calculated by subtracting the corresponding background control value (media control). If the result would be less than zero after background subtraction, the result was set to zero. Cytokine/Marker Names: CD40 ligand (CD40L); Cluster of Differentiation 107a (CD107a); Interferon gamma (IFNg); Macrophage Inflammatory Protein beta (MIP1B); Tumor Necrosis Factor alpha (TNFa)
    Time Frame At 48 weeks

    Outcome Measure Data

    Analysis Population Description
    Participants who maintained HIV-1 RNA<50 copies/mL at week 48 with no ART interruption of 7 or more consecutive days, no prior virologic failure (defined as having two consecutive HIV-1 RNA >200 copies/mL at week 24 or later or at any time after achieving HIV-1 RNA <50 copies/mL ), had available CAHD results from week 48 or week 49, had available immunology marker results where active control result is greater than or equal to the media control, and were enrolled during Fiebig Stage I-V.
    Arm/Group Title Arm 1: Fiebig I/II Arm 2: Fiebig III/IV Arm 3: Fiebig V
    Arm/Group Description Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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.
    Measure Participants 37 60 46
    CD8+ T-cell Response to Env
    0.00
    0.00
    0.00
    CD8+ T-cell Response to Gag
    0.15
    0.33
    0.28
    CD8+ T-cell Response to Nef
    0.03
    0.15
    0.33
    CD8+ T-cell Response to Pol
    0.00
    0.05
    0.08
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.97
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.21
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Env protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.12
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.055
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.28
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Gag protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.38
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.35
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 9
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Nef protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.045
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 10
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 2 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.085
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 11
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 1 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.044
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    Statistical Analysis 12
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Null Hypothesis: There is no difference between Arm 2 and Arm 3 in percentage of HIV-1-specific CD8+ T-cells expressing any cytokine (CD40L, CD107a, IFNg, MIP1B, TNFa) in response to Pol protein stimulant.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.60
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Wilcoxon (Mann-Whitney)
    Comments
    4. Secondary Outcome
    Title Proportion of Participants With Undetectable Cell-associated HIV-1 DNA (CAHD) Prior to ART Initiation
    Description Proportion of participants with 0 copies of CAHD per million CD4+ blood-derived CD4+ T-cells (assayed by quantitative PCR [qPCR]), assessed separately and jointly by integrase and gag assays. In order for a participant to be considered as having 0 copies of CAHD for joint assays, the participant must be found to have an undetectable CAHD result from both integrase and gag assays. If all participants in both arms had undetectable CAHD then the statistical test was not performed.
    Time Frame At week 0

    Outcome Measure Data

    Analysis Population Description
    All participants who enrolled during Fiebig Stage I-V and had available CAHD at week 0.
    Arm/Group Title Arm 1: Fiebig I/II Arm 2: Fiebig III/IV Arm 3: Fiebig V
    Arm/Group Description Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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.
    Measure Participants 48 78 60
    Joint Assay (Integrase + Gag)
    0.00
    0%
    0.01
    0%
    0.00
    0%
    Integrase Assay
    0.04
    0.1%
    0.03
    0%
    0.07
    0.1%
    Gag Assay
    0.00
    0%
    0.01
    0%
    0.00
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Results from Joint Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Results from Joint Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.64
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 3: Fiebig V
    Comments Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 3 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.69
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Results from Integrase Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.40
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Arm 1: Fiebig I/II, Arm 2: Fiebig III/IV
    Comments Results from Gag Assay. Null Hypothesis: There is no difference between Arm 1 and Arm 2 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Arm 2: Fiebig III/IV, Arm 3: Fiebig V
    Comments Results from Gag Assay. Null Hypothesis: There is no difference between Arm 2 and Arm 3 in the proportion of participants with undetectable CA-DNA.
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 1
    Comments No adjustments for multiple comparisons. P-value based on two-sided test.
    Method Fisher Exact
    Comments

    Adverse Events

    Time Frame From study entry to Week 72 or premature study discontinuation on Step 1.
    Adverse Event Reporting Description All Grade ≥3 signs and symptoms, Grade ≥2 laboratory findings, all targeted diagnoses, adverse events (AEs) that led to a change in study treatment/intervention regardless of grade, and all AEs meeting serious adverse event (SAE) definition or expediated adverse event (EAE) reporting requirement were collected. The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected Version 2.1, July 2017 was used.
    Arm/Group Title Arm 1: Fiebig I/II Arm 2: Fiebig III/IV Arm 3: Fiebig V Fiebig VI HIV-negative
    Arm/Group Description Participants enrolled during Fiebig stages I or II (non-reactive HIV-1 antibody). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stages III or IV (reactive HIV-1 antibody and negative or indeterminate results on the Western blot or Geenius HIV-1/HIV-2). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stage V (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants enrolled during Fiebig stage VI (reactive HIV-1 antibody and positive Western blot or Geenius HIV-1/HIV-2 without p31 band). elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or bictegravir/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy: 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. Participants found to be HIV negative following the results of HIV-1 RNA testing at study entry. No study treatment.
    All Cause Mortality
    Arm 1: Fiebig I/II Arm 2: Fiebig III/IV Arm 3: Fiebig V Fiebig VI HIV-negative
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/49 (0%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Serious Adverse Events
    Arm 1: Fiebig I/II Arm 2: Fiebig III/IV Arm 3: Fiebig V Fiebig VI HIV-negative
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 7/49 (14.3%) 8/79 (10.1%) 6/60 (10%) 0/4 (0%) 0/3 (0%)
    Cardiac disorders
    Pericarditis 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Abdominal pain upper 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Constipation 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Haematemesis 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Rectal fissure 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Infections and infestations
    COVID-19 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Cellulitis 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Gastroenteritis 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Groin abscess 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Hepatitis A 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Lymphadenitis bacterial 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Perirectal abscess 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Pharyngitis 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Secondary syphilis 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Investigations
    Alanine aminotransferase increased 0/49 (0%) 1/79 (1.3%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Aspartate aminotransferase increased 0/49 (0%) 1/79 (1.3%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Hepatitis B surface antigen positive 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Metabolism and nutrition disorders
    Hyperglycaemia 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Nervous system disorders
    Cervical cord compression 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Headache 1/49 (2%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Psychiatric disorders
    Adjustment disorder with depressed mood 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Anxiety 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Panic attack 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Substance-induced psychotic disorder 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Suicidal ideation 1/49 (2%) 1/79 (1.3%) 2/60 (3.3%) 0/4 (0%) 0/3 (0%)
    Suicide attempt 2/49 (4.1%) 1/79 (1.3%) 2/60 (3.3%) 0/4 (0%) 0/3 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Skin and subcutaneous tissue disorders
    Vascular skin disorder 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Other (Not Including Serious) Adverse Events
    Arm 1: Fiebig I/II Arm 2: Fiebig III/IV Arm 3: Fiebig V Fiebig VI HIV-negative
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 48/49 (98%) 67/79 (84.8%) 50/60 (83.3%) 4/4 (100%) 1/3 (33.3%)
    Blood and lymphatic system disorders
    Iron deficiency anaemia 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Neutropenia 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Thrombocytopenia 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Cardiac disorders
    Atrial fibrillation 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Palpitations 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Congenital, familial and genetic disorders
    Gilbert's syndrome 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Thalassaemia 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Endocrine disorders
    Hyperthyroidism 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Eye disorders
    Chalazion 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Gastrointestinal disorders
    Abdominal pain 1/49 (2%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Abdominal pain upper 1/49 (2%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Anal fissure 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Anogenital dysplasia 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Anorectal discomfort 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Constipation 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Diarrhoea 2/49 (4.1%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Gastrointestinal disorder 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Gastrooesophageal reflux disease 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Haematemesis 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Haemorrhoids 0/49 (0%) 1/79 (1.3%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Nausea 0/49 (0%) 2/79 (2.5%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Proctitis 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Vomiting 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    General disorders
    Fatigue 0/49 (0%) 2/79 (2.5%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Pain 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Pyrexia 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Infections and infestations
    Abscess limb 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Acarodermatitis 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Acute hepatitis C 2/49 (4.1%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Anal chlamydia infection 6/49 (12.2%) 1/79 (1.3%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Bacterial diarrhoea 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Bacterial vaginosis 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Balanitis candida 0/49 (0%) 1/79 (1.3%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Bronchitis 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    COVID-19 0/49 (0%) 2/79 (2.5%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Cellulitis 0/49 (0%) 0/79 (0%) 2/60 (3.3%) 0/4 (0%) 0/3 (0%)
    Epididymitis 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Genital herpes simplex 0/49 (0%) 2/79 (2.5%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Genitourinary chlamydia infection 1/49 (2%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Genitourinary tract gonococcal infection 0/49 (0%) 1/79 (1.3%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Gonococcal infection 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Helicobacter gastritis 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Hepatitis C 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Large intestine infection 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Latent syphilis 3/49 (6.1%) 3/79 (3.8%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Latent tuberculosis 1/49 (2%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Neurosyphilis 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Oesophageal candidiasis 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Oropharyngeal gonococcal infection 4/49 (8.2%) 1/79 (1.3%) 3/60 (5%) 0/4 (0%) 0/3 (0%)
    Perirectal abscess 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Pharyngeal chlamydia infection 1/49 (2%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Pneumonia bacterial 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Primary syphilis 2/49 (4.1%) 2/79 (2.5%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Proctitis chlamydial 1/49 (2%) 1/79 (1.3%) 2/60 (3.3%) 0/4 (0%) 0/3 (0%)
    Proctitis gonococcal 3/49 (6.1%) 3/79 (3.8%) 2/60 (3.3%) 0/4 (0%) 0/3 (0%)
    Secondary syphilis 4/49 (8.2%) 5/79 (6.3%) 3/60 (5%) 0/4 (0%) 0/3 (0%)
    Shigella infection 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Subcutaneous abscess 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Syphilis genital 2/49 (4.1%) 4/79 (5.1%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Tonsillitis 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Trichomoniasis 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Tubo-ovarian abscess 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Upper respiratory tract infection 1/49 (2%) 1/79 (1.3%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Urethritis 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Urethritis chlamydial 1/49 (2%) 1/79 (1.3%) 2/60 (3.3%) 0/4 (0%) 0/3 (0%)
    Urethritis gonococcal 1/49 (2%) 1/79 (1.3%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Urinary tract infection 2/49 (4.1%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Urinary tract infection bacterial 0/49 (0%) 2/79 (2.5%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Vulvovaginal candidiasis 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Vulvovaginitis gonococcal 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Injury, poisoning and procedural complications
    Foot fracture 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Skin laceration 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Tibia fracture 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Investigations
    Alanine aminotransferase increased 6/49 (12.2%) 5/79 (6.3%) 3/60 (5%) 0/4 (0%) 0/3 (0%)
    Aspartate aminotransferase increased 5/49 (10.2%) 5/79 (6.3%) 4/60 (6.7%) 0/4 (0%) 0/3 (0%)
    Bilirubin conjugated increased 1/49 (2%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Blood alkaline phosphatase increased 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Blood bilirubin increased 2/49 (4.1%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Blood cholesterol increased 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Blood creatine phosphokinase increased 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Blood creatinine decreased 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Blood creatinine increased 14/49 (28.6%) 10/79 (12.7%) 13/60 (21.7%) 0/4 (0%) 0/3 (0%)
    Blood glucose decreased 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Blood glucose increased 0/49 (0%) 4/79 (5.1%) 3/60 (5%) 0/4 (0%) 0/3 (0%)
    Blood magnesium decreased 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Blood sodium decreased 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Chlamydia test positive 2/49 (4.1%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Creatinine renal clearance decreased 34/49 (69.4%) 58/79 (73.4%) 45/60 (75%) 4/4 (100%) 1/3 (33.3%)
    Gamma-glutamyltransferase increased 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Glomerular filtration rate decreased 5/49 (10.2%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Hepatic enzyme increased 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Liver function test abnormal 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Lymphocyte count decreased 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Neisseria test positive 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Neutrophil count decreased 0/49 (0%) 1/79 (1.3%) 3/60 (5%) 0/4 (0%) 0/3 (0%)
    Platelet count decreased 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Prothrombin time prolonged 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Treponema test positive 2/49 (4.1%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Trichomonal test positive 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Tuberculin test positive 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Weight decreased 2/49 (4.1%) 1/79 (1.3%) 2/60 (3.3%) 0/4 (0%) 0/3 (0%)
    Metabolism and nutrition disorders
    Abnormal loss of weight 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Decreased appetite 2/49 (4.1%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Hyperglycaemia 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Hyperlipidaemia 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Hypokalaemia 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Type 2 diabetes mellitus 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Vitamin B complex deficiency 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Vitamin D deficiency 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Back pain 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Facet joint syndrome 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Rhabdomyolysis 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Spinal osteoarthritis 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts 1/49 (2%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Prostate cancer 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Nervous system disorders
    Headache 2/49 (4.1%) 1/79 (1.3%) 2/60 (3.3%) 0/4 (0%) 0/3 (0%)
    Tremor 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Psychiatric disorders
    Adjustment disorder with mixed anxiety and depressed mood 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Agitated depression 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Anxiety 2/49 (4.1%) 1/79 (1.3%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Bipolar disorder 0/49 (0%) 1/79 (1.3%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Depressed mood 1/49 (2%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Depression 1/49 (2%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Insomnia 1/49 (2%) 0/79 (0%) 2/60 (3.3%) 0/4 (0%) 0/3 (0%)
    Suicidal ideation 1/49 (2%) 0/79 (0%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Renal and urinary disorders
    Acute kidney injury 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Dysuria 1/49 (2%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Reproductive system and breast disorders
    Balanoposthitis 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Penile discharge 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Testicular pain 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Testicular swelling 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Vaginal discharge 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Vulvovaginal pruritus 0/49 (0%) 0/79 (0%) 1/60 (1.7%) 0/4 (0%) 0/3 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Skin and subcutaneous tissue disorders
    Penile ulceration 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Pruritus 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Rash 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Rash erythematous 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Rash pruritic 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Urticaria 0/49 (0%) 1/79 (1.3%) 0/60 (0%) 0/4 (0%) 0/3 (0%)
    Vascular disorders
    Hypertension 2/49 (4.1%) 3/79 (3.8%) 1/60 (1.7%) 1/4 (25%) 0/3 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    In accordance with the Clinical Trials Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.

    Results Point of Contact

    Name/Title ACTG Clinicaltrials.gov Coordinator
    Organization ACTG Network Coordinating Center, Social and Scientific Systems, a DLH Holdings Company
    Phone (301) 628-3348
    Email ACTGCT.gov@fstrf.org
    Responsible Party:
    AIDS Clinical Trials Group
    ClinicalTrials.gov Identifier:
    NCT02859558
    Other Study ID Numbers:
    • ACTG A5354
    • 2UM1AI068636
    First Posted:
    Aug 9, 2016
    Last Update Posted:
    Feb 21, 2022
    Last Verified:
    Jan 1, 2022