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Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
Overall Status
Completed
CT.gov ID
NCT01505114
Collaborator
HIV Prevention Trials Network (Other), AIDS Clinical Trials Group (Other)
594
Enrollment
13
Locations
4
Arms
41
Actual Duration (Months)
45.7
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Pre-exposure prophylaxis (PrEP) is a method of preventing HIV infection through the use of antiretroviral (ARV) medications before exposure to HIV. This study will evaluate the safety and tolerability of four ARV regimens in preventing HIV infection in men who have sex with men who may be at risk of getting HIV infection through sex and women who may be at risk of getting HIV infection through sex. The four ARV regimens being evaluated are maraviroc (MVC), MVC plus emtricitabine (FTC), MVC plus tenofovir disoproxil fumarate (TDF), and TDF plus FTC. The MVC-containing arms will be compared to TDF/FTC alone and in combination.

Condition or Disease Intervention/Treatment Phase
  • Drug: Maraviroc
  • Drug: Emtricitabine
  • Drug: Tenofovir disoproxil fumarate
  • Other: Maraviroc placebo
  • Other: Emtricitabine placebo
  • Other: Tenofovir disoproxil fumarate placebo
 Phase 2

Detailed Description

Several clinical trials are currently under way evaluating the safety and efficacy of ARV-based PrEP for preventing HIV infection. In 2010, the results of the first efficacy trial of ARV-based PrEP showed 44% fewer HIV infections among study participants receiving the study drugs (TDF and FTC) than among those receiving placebo. Although these results are promising, concerns about poor adherence, drug resistance, and toxicity prompt further exploration of ARV PrEP regimens. This trial will evaluate the safety and tolerability of PrEP using four ARV regimens in reducing HIV transmission in at-risk men who have sex with men and in at-risk women.

Participants will be randomly assigned to one of four arms: Arm 1, Arm 2, Arm 3, or Arm 4. Arm 1 will receive MVC, FTC placebo, and TDF placebo orally once daily from Week 0 through 48. Arm 2 will receive MVC, FTC, and TDF placebo orally once daily from Week 0 through 48. Arm 3 will receive MVC, FTC placebo, and TDF orally once daily from Week 0 through 48. Participants in Arm 4 will receive MVC placebo, FTC, and TDF orally once daily from Week 0 through 48.

Study visits will occur at enrollment and Weeks 2, 4, 8, 16, 24, 32, 40, 48, and 49. All study visits will include a physical examination, blood collection and storage, and HIV counseling and testing. Select study visits will include adherence counseling, surveys, behavioral assessments (including sexual behavioral assessments), urine collection, and dual-energy x-ray absorptiometry (DXA). Participants will also undergo sexual behavioral assessments randomly 12 to 13 times through Week 48 via short message service (SMS). Some female participants may opt into taking part in an interview at Week 48.

Participants who enroll in this study may also consent to be a part of two subset evaluations as part of this study: the Drug Interaction Subset or the Tissue Subset. Enrollment in these subsets will involve additional study procedures. The Drug Interaction Subset will undergo blood collection before and after a directly observed dose of study drug at the Week 2 visit. Participants in the Tissue Subset will take part in additional study procedures at select visits, including blood collection, hair collection, and rectal tissue and fluid collection (required for men; optional for women). Women involved in the Tissue Subset will also undergo cervical tissue and cervicovaginal fluid collection at select visits.

Study Design

Study Type:
Interventional
Actual Enrollment :
594 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Prevention
Official Title:
A Phase II Randomized, Double-Blind, Study of the Safety and Tolerability of Maraviroc (MVC), Maraviroc + Emtricitabine (MVC+FTC), Maraviroc + Tenofovir Disoproxil Fumarate (MVC+TDF), or Tenofovir Disoproxil Fumarate + Emtricitabine (TDF+FTC) For Pre-Exposure Prophylaxis (PrEP) To Prevent HIV Transmission in At-Risk Men Who Have Sex With Men and in At-Risk Women
Actual Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1

MVC 300 mg plus FTC placebo and TDF placebo orally once daily

Drug: Maraviroc
300-mg tablet, once daily, from Week 0 through Week 48
Other Names:
  • Selzentry
  • MVC

    • Other: Emtricitabine placebo
    Once daily from Week 0 through Week 48

    Other: Tenofovir disoproxil fumarate placebo
    Once daily from Week 0 through Week 48
    Experimental: Arm 2

    MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily

    Drug: Maraviroc
    300-mg tablet, once daily, from Week 0 through Week 48
    Other Names:
  • Selzentry
  • MVC

    • Drug: Emtricitabine
    200-mg capsule, once daily, from Week 0 through Week 48
    Other Names:
  • Emtriva
  • FTC

    • Other: Tenofovir disoproxil fumarate placebo
    Once daily from Week 0 through Week 48
    Experimental: Arm 3

    MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily

    Drug: Maraviroc
    300-mg tablet, once daily, from Week 0 through Week 48
    Other Names:
  • Selzentry
  • MVC

    • Drug: Tenofovir disoproxil fumarate
    300-mg tablet, once daily, from Week 0 through Week 48
    Other Names:
  • Viread
  • TDF

    • Other: Emtricitabine placebo
    Once daily from Week 0 through Week 48
    Experimental: Arm 4

    MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily

    Drug: Emtricitabine
    200-mg capsule, once daily, from Week 0 through Week 48
    Other Names:
  • Emtriva
  • FTC

    • Drug: Tenofovir disoproxil fumarate
    300-mg tablet, once daily, from Week 0 through Week 48
    Other Names:
  • Viread
  • TDF

    • Other: Maraviroc placebo
    Once daily from Week 0 through Week 48

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of Grade 3 or Higher Adverse Events (AEs) [Through Week 48]

      participants had Occurrence of Grade 3 or higher adverse events (AEs)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • For participants in the men's component of the study, born male. For participants in the women's component of the study, born female.

    • 18 years or older at the time of screening

    • Willing to provide informed consent for the study

    • Able to read at a level required for the study components (e.g., computer-assisted self-interview [CASI] and short message service [SMS], per the judgment of the study investigator)

    • For men, a history of receptive or insertive anal intercourse without use of condoms with at least one HIV-infected male partner or male partner of unknown HIV serostatus within 90 days of study entry (provided by self-report)

    • For women, a history of vaginal intercourse or receptive anal intercourse without use of condoms with at least one HIV-infected male partner or male partner of unknown HIV serostatus within 90 days of study entry (provided by self-report)

    • The following laboratory values must be from specimens obtained within 45 days prior to study enrollment: Nonreactive HIV test results (more information on this criterion can be found in the protocol); hemoglobin (men) greater than 11 g/dL; hemoglobin (women) greater than or equal to 10.5 g/dL; absolute neutrophil count greater than 750 cells/mm3; platelet count greater than or equal to 100,000/mm3; for men and women, calculated creatinine clearance greater than or equal to 70 mL/minute using the Cockcroft-Gault equation; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 3 times the upper limit of normal (ULN); total bilirubin less than 2.5 ULN; urine protein less than 2+; and hepatitis B surface antigen (HBsAg) negative.

    • No alcohol or substance use that, in the opinion of the study investigator, would interfere with the conduct of the study (e.g., provided by self-report or found upon medical history and examination or in available medical records)

    • No medical condition that, in the opinion of the study investigator, would interfere with the conduct of the study (e.g., provided by self-report or found upon medical history and examination or in available medical records)

    • Willing to undergo all required study procedures (including sexual assessment by CASI, use of the drug monitoring device, and SMS [i.e., texting])

    • For all women participants: If of reproductive potential (defined as girls who have reached menarche and pre-menopausal women who have not had a sterilization procedure per self-report (e.g., hysterectomy, bilateral oophorectomy, tubal ligation or salpingectomy), must have a negative serum or urine pregnancy test performed within 48 hours before initiating the protocol-specified medication(s). More information on this criterion can be found in the protocol.

    • For all women participants: If participating in sexual activity that could lead to pregnancy, must agree to use a form of contraception from the following list during the trial and for 30 days after stopping the study medication: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or hormone-base contraceptive.

    Inclusion Criteria for the Tissue Subset:

    • For men and women participating in the rectal component, willing to abstain from receptive anal intercourse and practices involving insertion of anything in the rectum (drug, enema, penis, or sex toy) for 3 days prior to rectal biopsy and for 7 days post-biopsy, to minimize risk of HIV-1 infection and bleeding complications after each procedure

    • For women participating in the vaginal component, willing to abstain from vaginal intercourse and practices involving insertion of anything in the vagina (drug, douche, penis, or sex toy) for 3 days prior to cervical biopsy and for 7 days post-biopsy, to minimize risk of HIV-1 infection and bleeding complications after each procedure

    • For women only, per participant report at screening, usual menstrual cycle with at least 21 days between menses (does not apply to participants who report using a progestin-only method of contraception at screening, e.g., Depo-Provera)

    • For women, satisfactory Pap results in the 12 calendar months prior to enrollment consistent with Grade 0 according to the Female Genital Grading Table for Use in Microbicide Studies Addendum 1 to the DAIDS Table for Grading Adult and Pediatric Adverse Events, Version 1.0, December 2004 (Clarification dated August 2009), or satisfactory evaluation with no treatment required of Grade 1 or higher Pap result per American Society for Colposcopy and Cervical Pathology (ASCCP) guidelines in the 12 calendar months prior to enrollment. If there is no document of satisfactory Pap results, the participant should be offered to have the test performed by the site prior to the enrollment visit. If they refuse, they are not eligible.

    Exclusion Criteria:

    • One or more reactive HIV test results at screening or enrollment, even if HIV infection is not confirmed

    • Coenrollment in any other HIV interventional research study (provided by self-report or other available documentation) or prior enrollment and receipt of active arm (i.e., NOT a placebo) of an HIV vaccine trial (provided by available documentation)

    • Use of ARV therapy (e.g., for post-exposure prophylaxis [PEP] or PrEP) in the 90 days prior to study entry

    • Prior history of a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption (provided by self-report or obtained from medical history or records)

    • Receipt of prohibited medications as described in the study drug package inserts or listed in the Study-Specific Populations (SSP) Manual (provided by self-report or obtained from medical history or medical records)

    • Ongoing intravenous drug use: episodic use or any use in the past 90 days (as assessed by the study investigator)

    • Known medical history of allergy to soy (soya or soybeans) or peanuts

    • Weight exceeding 300 pounds (exceeds weight limit of DXA scanners)

    • For women, pregnancy or currently breastfeeding

    Exclusion Criteria for the Tissue Subset:
    For Men and Women:

    • The following applies to men, and only to women who opt for rectal sampling: Abnormalities of the colorectal mucosa or significant colorectal symptom(s), which in the opinion of the study investigator represent a contraindication to biopsy (including but not limited to presence of any unresolved injury, infectious or inflammatory condition of the local mucosa, and presence of symptomatic external hemorrhoids)

    • Per participant report at screening, anticipated use and/or unwillingness to abstain from the following medications during the period of study participation: Heparin, including Lovenox®, Warfarin, Plavix® (clopidogrel bisulfate), or any other drugs that are associated with increased risk of bleeding following biopsy procedures in the opinion of the study investigator

    • The following applies to men, and only to women who opt for rectal sampling: Per participant report at screening, anticipated use and/or unwillingness to abstain from rectally administered medications (including over-the-counter products) for 3 days prior to rectal biopsies and for 7 days after biopsies

    • Per participant report at screening, anticipated use and/or unwillingness to abstain from the following medications for a period of 10 days before a biopsy procedure: aspirin (daily use of low-dose aspirin [no more than 81 mg] is allowed at the discretion of the Investigator of Record) or non-steroidal anti-inflammatory drugs (NSAIDS)

    • Abnormal laboratory results for coagulation tests that may indicate an increased risk of bleeding (in the opinion of the investigators)

    • Active untreated syphilis, gonorrhea, or chlamydia infection

    For Women Only:

    • Carcinoma in situ of the cervix or invasive cervical cancer. Abnormalities of the vaginal mucosa or significant vaginal symptom(s), which in the opinion of the study investigator represent a contraindication to biopsy (including but not limited to presence of any unresolved injury, and infectious or inflammatory condition of the local mucosa).

    • Hysterectomy

    • Per participant report at screening, anticipated use and/or unwillingness to abstain from vaginally administered medications (including over-the-counter products) and vaginal douching for 3 days prior to cervical biopsies and for 7 days after biopsies

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA CARE Center CRS Los Angeles California United States 90035
    2 Bridge HIV CRS San Francisco California United States 94143
    3 George Washington Univ. CRS Washington District of Columbia United States 20006
    4 Johns Hopkins University CRS Baltimore Maryland United States 21205
    5 Fenway Health (FH) CRS Boston Massachusetts United States 02215-4302
    6 New Jersey Medical School Clinical Research Center CRS Newark New Jersey United States 07103
    7 Weill Cornell Chelsea CRS New York New York United States 10010
    8 Chapel Hill CRS Chapel Hill North Carolina United States 27599
    9 Case Clinical Research Site Cleveland Ohio United States 44106
    10 Penn Therapeutics, CRS Philadelphia Pennsylvania United States 19104
    11 University of Pittsburgh CRS Pittsburgh Pennsylvania United States 15213
    12 University of Washington AIDS CRS Seattle Washington United States 98104-9929
    13 Puerto Rico AIDS Clinical Trials Unit CRS San Juan Puerto Rico 00935

    Sponsors and Collaborators

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

    Investigators

    • Study Chair: Roy M. Gulick, MD, MPH, Weill Medical College of Cornell University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT01505114
    Other Study ID Numbers:
    • HPTN 069/A5305 (NEXT Prep)
    • 11789
    • HPTN 069/A5305
    • HPTN 069
    • HPTN 069/NEXT Prep
    First Posted:
    Jan 6, 2012
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Jun 1, 2017
    Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID)
    HIV Prevention
    PrEP
    Maraviroc
    Additional relevant MeSH terms:
    Infections
    HIV Infections
    Acquired Immunodeficiency Syndrome
    Tenofovir
    Emtricitabine
    Maraviroc

    Study Results

    Participant Flow

    Recruitment Details The study started the enrollment in June 2012. Accrual will occur in a staggered fashion, with men beginning first and women beginning several months later. Accrual for the men will occur over approximately 9 months, and accrual for the women will require approximately 9 months.
    Pre-assignment Detail Exclusion--reactive HIV test results;Co-enrollment in any other HIV interventional research study; Use of ARV therapy; Prior history of any procedure altering the gastrointestinal tract or drug absorption; Receipt of prohibited medications; Known allergy to soy/peanuts; Weight>300 lbs;
    Arm/Group Title MVC Only MVC + FTC MVC + TDF TDF + FTC
    Arm/Group Description MVC 300 mg plus FTC placebo and TDF placebo orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine placebo: Once daily from Week 0 through Week 48 Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48 MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48 MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine placebo: Once daily from Week 0 through Week 48 MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48 Maraviroc placebo: Once daily from Week 0 through Week 48
    Period Title: Overall Study
    STARTED 148 148 147 151
    COMPLETED 123 135 129 128
    NOT COMPLETED 25 13 18 23

    Baseline Characteristics

    Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4 Total
    Arm/Group Description MVC 300 mg plus FTC placebo and TDF placebo orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine placebo: Once daily from Week 0 through Week 48 Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48 MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48 MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine placebo: Once daily from Week 0 through Week 48 MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48 Maraviroc placebo: Once daily from Week 0 through Week 48 Total of all reporting groups
    Overall Participants 147 151 148 148 594
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    30
    29.5
    30
    31
    30
    Age (years) [Median (Full Range) ]
    Women
    40
    36
    37
    37
    36
    Sex: Female, Male (Count of Participants)
    Female
    46
    31.3%
    45
    29.8%
    49
    33.1%
    48
    32.4%
    188
    31.6%
    Male
    101
    68.7%
    106
    70.2%
    99
    66.9%
    100
    67.6%
    406
    68.4%
    Race/Ethnicity, Customized (Count of Participants)
    American Indian/Alaskan Native
    4
    2.7%
    6
    4%
    2
    1.4%
    5
    3.4%
    17
    2.9%
    Asian
    6
    4.1%
    1
    0.7%
    5
    3.4%
    5
    3.4%
    17
    2.9%
    Black or African
    61
    41.5%
    64
    42.4%
    62
    41.9%
    51
    34.5%
    238
    40.1%
    Native Hawaiian or Pacific Islander
    1
    0.7%
    2
    1.3%
    1
    0.7%
    3
    2%
    7
    1.2%
    White
    73
    49.7%
    80
    53%
    72
    48.6%
    78
    52.7%
    303
    51%
    Other
    15
    10.2%
    14
    9.3%
    10
    6.8%
    16
    10.8%
    55
    9.3%
    education (Count of Participants)
    8th Grade or Less
    1
    0.7%
    3
    2%
    0
    0%
    1
    0.7%
    5
    0.8%
    Some High School
    10
    6.8%
    7
    4.6%
    6
    4.1%
    9
    6.1%
    32
    5.4%
    High School Graduate or Equivalent
    35
    23.8%
    27
    17.9%
    25
    16.9%
    27
    18.2%
    114
    19.2%
    Vocational/Trade/Technical School
    3
    2%
    7
    4.6%
    7
    4.7%
    6
    4.1%
    23
    3.9%
    Some College or 2 Year Degree
    51
    34.7%
    43
    28.5%
    57
    38.5%
    55
    37.2%
    206
    34.7%
    Finished College
    37
    25.2%
    40
    26.5%
    36
    24.3%
    40
    27%
    153
    25.8%
    masters or other advanced degree
    10
    6.8%
    24
    15.9%
    17
    11.5%
    10
    6.8%
    61
    10.3%
    Marital Status (Count of Participants)
    Married/Civil Union/Legal Partnership
    8
    5.4%
    9
    6%
    7
    4.7%
    14
    9.5%
    38
    6.4%
    Living with Primary Partner
    25
    17%
    21
    13.9%
    25
    16.9%
    21
    14.2%
    92
    15.5%
    Not Living with Primary Partner
    12
    8.2%
    17
    11.3%
    19
    12.8%
    14
    9.5%
    62
    10.4%
    Single/Divorced/Widowed
    102
    69.4%
    103
    68.2%
    96
    64.9%
    98
    66.2%
    399
    67.2%
    Other
    0
    0%
    1
    0.7%
    1
    0.7%
    1
    0.7%
    3
    0.5%
    Employment Status (Count of Participants)
    Full-time Employment
    56
    38.1%
    68
    45%
    59
    39.9%
    74
    50%
    257
    43.3%
    Part-time Employment
    38
    25.9%
    35
    23.2%
    36
    24.3%
    25
    16.9%
    134
    22.6%
    Not Employed
    53
    36.1%
    48
    31.8%
    52
    35.1%
    49
    33.1%
    202
    34%

    Outcome Measures

    1. Primary Outcome
    Title Occurrence of Grade 3 or Higher Adverse Events (AEs)
    Description participants had Occurrence of Grade 3 or higher adverse events (AEs)
    Time Frame Through Week 48

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
    Arm/Group Description MVC 300 mg plus FTC placebo and TDF placebo orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine placebo: Once daily from Week 0 through Week 48 Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48 MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48 MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine placebo: Once daily from Week 0 through Week 48 MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48 Maraviroc placebo: Once daily from Week 0 through Week 48
    Measure Participants 147 151 148 148
    Count of Participants [Participants]
    18
    12.2%
    24
    15.9%
    20
    13.5%
    28
    18.9%

    Adverse Events

    Time Frame 49 weeks
    Adverse Event Reporting Description
    Arm/Group Title Arm 1 Arm 2 Arm 3 Arm 4
    Arm/Group Description MVC 300 mg plus FTC placebo and TDF placebo orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine placebo: Once daily from Week 0 through Week 48 Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48 MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48 MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48 Emtricitabine placebo: Once daily from Week 0 through Week 48 MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48 Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48 Maraviroc placebo: Once daily from Week 0 through Week 48
    All Cause Mortality
    Arm 1 Arm 2 Arm 3 Arm 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/147 (0%) 1/151 (0.7%) 1/148 (0.7%) 0/148 (0%)
    Serious Adverse Events
    Arm 1 Arm 2 Arm 3 Arm 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 10/147 (6.8%) 5/151 (3.3%) 4/148 (2.7%) 11/148 (7.4%)
    Cardiac disorders
    Cardiac arrest 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Cardiac failure congestive 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Myocardial infarction 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Congenital, familial and genetic disorders
    Congenital anomaly in offspring 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    General disorders
    Malaise 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Immune system disorders
    Hypersensitivity 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Infections and infestations
    Appendicitis perforated 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Chikungunya virus infection 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Diverticulitis 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Gastroenteritis 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Gastroenteritis viral 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Influenza 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Pneumonia streptococcal 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Staphylococcal skin infection 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Urinary tract infection 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Injury, poisoning and procedural complications
    Craniocerebral injury 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Overdose 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Toxicity to various agents 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Upper limb fracture 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosus 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Clear cell renal cell carcinoma 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Nervous system disorders
    Seizure 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Pregnancy, puerperium and perinatal conditions
    Abortion late 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Abortion spontaneous 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Ectopic pregnancy 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Pre-eclampsia 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Psychiatric disorders
    Completed suicide 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Depression 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Major depression 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Suicidal ideation 1/147 (0.7%) 2 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax spontaneous 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Other (Not Including Serious) Adverse Events
    Arm 1 Arm 2 Arm 3 Arm 4
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 78/147 (53.1%) 86/151 (57%) 84/148 (56.8%) 91/148 (61.5%)
    Blood and lymphatic system disorders
    Anaemia 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Lymphadenopathy 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Neutropenia 1/147 (0.7%) 1 2/151 (1.3%) 2 1/148 (0.7%) 1 4/148 (2.7%) 5
    Cardiac disorders
    Tachycardia 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Congenital, familial and genetic disorders
    Gilbert's syndrome 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Ear and labyrinth disorders
    Ear pain 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Motion sickness 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Tympanic membrane perforation 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Vertigo 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Endocrine disorders
    Hypothyroidism 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Eye disorders
    Dry eye 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Eye irritation 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Eye pruritus 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Eye swelling 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Ocular hyperaemia 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Retinal detachment 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Vision blurred 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Gastrointestinal disorders
    Abdominal discomfort 2/147 (1.4%) 2 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Abdominal distension 2/147 (1.4%) 2 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Abdominal pain 1/147 (0.7%) 1 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Abdominal pain lower 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Abdominal pain upper 2/147 (1.4%) 2 1/151 (0.7%) 1 1/148 (0.7%) 1 2/148 (1.4%) 2
    Anal fissure 1/147 (0.7%) 1 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Anogenital dysplasia 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 1/148 (0.7%) 2
    Anorectal disorder 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Constipation 1/147 (0.7%) 1 3/151 (2%) 3 3/148 (2%) 3 0/148 (0%) 0
    Dental caries 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Diarrhoea 13/147 (8.8%) 13 6/151 (4%) 6 3/148 (2%) 3 8/148 (5.4%) 11
    Dyspepsia 1/147 (0.7%) 1 0/151 (0%) 0 2/148 (1.4%) 3 1/148 (0.7%) 1
    Dysphagia 1/147 (0.7%) 2 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Faeces soft 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Flatulence 2/147 (1.4%) 2 0/151 (0%) 0 2/148 (1.4%) 2 0/148 (0%) 0
    Food poisoning 1/147 (0.7%) 1 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Gastrooesophageal reflux disease 2/147 (1.4%) 2 1/151 (0.7%) 1 0/148 (0%) 0 3/148 (2%) 3
    Gingival recession 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Haematochezia 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Haemorrhoids 1/147 (0.7%) 1 0/151 (0%) 0 1/148 (0.7%) 2 0/148 (0%) 0
    Hiatus hernia 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 2/148 (1.4%) 2
    Lip swelling 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Mouth ulceration 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Nausea 7/147 (4.8%) 7 6/151 (4%) 6 2/148 (1.4%) 2 5/148 (3.4%) 6
    Oesophageal ulcer 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Proctalgia 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Rectal discharge 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Rectal tenesmus 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Toothache 1/147 (0.7%) 1 2/151 (1.3%) 2 0/148 (0%) 0 1/148 (0.7%) 1
    Vomiting 3/147 (2%) 3 4/151 (2.6%) 4 0/148 (0%) 0 2/148 (1.4%) 2
    General disorders
    Chest pain 1/147 (0.7%) 1 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Chills 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Early satiety 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Face oedema 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Fat tissue increased 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Fatigue 4/147 (2.7%) 4 1/151 (0.7%) 1 1/148 (0.7%) 1 1/148 (0.7%) 1
    Influenza like illness 2/147 (1.4%) 2 3/151 (2%) 3 1/148 (0.7%) 1 4/148 (2.7%) 4
    Malaise 1/147 (0.7%) 1 2/151 (1.3%) 2 0/148 (0%) 0 0/148 (0%) 0
    Pain 1/147 (0.7%) 2 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Pyrexia 1/147 (0.7%) 1 4/151 (2.6%) 4 2/148 (1.4%) 2 0/148 (0%) 0
    Hepatobiliary disorders
    Hepatic steatosis 1/147 (0.7%) 3 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Hyperbilirubinaemia 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 2/148 (1.4%) 2
    Immune system disorders
    Allergy to animal 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Anaphylactic reaction 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Drug hypersensitivity 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Food allergy 1/147 (0.7%) 2 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Hypersensitivity 2/147 (1.4%) 2 1/151 (0.7%) 2 0/148 (0%) 0 0/148 (0%) 0
    Multiple allergies 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Seasonal allergy 4/147 (2.7%) 4 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 2
    Infections and infestations
    Abdominal abscess 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Abscess neck 0/147 (0%) 0 1/151 (0.7%) 2 0/148 (0%) 0 0/148 (0%) 0
    Acarodermatitis 1/147 (0.7%) 1 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Anal abscess 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Anal chlamydia infection 0/147 (0%) 0 0/151 (0%) 0 3/148 (2%) 3 0/148 (0%) 0
    Anal infection 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Anal tinea 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Bacteriuria 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Body tinea 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Breast abscess 0/147 (0%) 0 2/151 (1.3%) 2 0/148 (0%) 0 0/148 (0%) 0
    Bronchitis 1/147 (0.7%) 1 0/151 (0%) 0 3/148 (2%) 4 0/148 (0%) 0
    Bronchitis viral 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Cellulitis 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Cellulitis of male external genital organ 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Cellulitis staphylococcal 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Chikungunya virus infection 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Chlamydial infection 4/147 (2.7%) 4 4/151 (2.6%) 6 1/148 (0.7%) 1 5/148 (3.4%) 5
    Cytomegalovirus infection 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Dermatophytosis 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Diarrhoea infectious 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Diverticulitis 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Ear infection 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Endometritis 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Epididymitis 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 2/148 (1.4%) 3
    Escherichia infection 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Eye infection 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Folliculitis 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Fungal skin infection 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Gastroenteritis 3/147 (2%) 3 2/151 (1.3%) 2 2/148 (1.4%) 2 3/148 (2%) 3
    Gastroenteritis viral 1/147 (0.7%) 1 6/151 (4%) 6 2/148 (1.4%) 2 4/148 (2.7%) 4
    Gastrointestinal infection 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Gastrointestinal viral infection 0/147 (0%) 0 1/151 (0.7%) 2 1/148 (0.7%) 1 0/148 (0%) 0
    Genital herpes 2/147 (1.4%) 2 1/151 (0.7%) 1 0/148 (0%) 0 2/148 (1.4%) 5
    Genitourinary tract gonococcal infection 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Gonorrhoea 3/147 (2%) 3 4/151 (2.6%) 4 2/148 (1.4%) 2 3/148 (2%) 3
    Herpes simplex 1/147 (0.7%) 1 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Herpes zoster 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Infected bite 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Infected skin ulcer 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Influenza 3/147 (2%) 3 0/151 (0%) 0 2/148 (1.4%) 2 1/148 (0.7%) 1
    Lyme disease 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Mastitis 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Nasopharyngitis 1/147 (0.7%) 2 3/151 (2%) 4 2/148 (1.4%) 2 5/148 (3.4%) 5
    Oesophageal candidiasis 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Onychomycosis 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Oral herpes 2/147 (1.4%) 2 1/151 (0.7%) 1 2/148 (1.4%) 2 1/148 (0.7%) 3
    Oral pustule 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Oropharyngeal gonococcal infection 4/147 (2.7%) 4 0/151 (0%) 0 3/148 (2%) 3 3/148 (2%) 3
    Otitis media 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Otitis media bacterial 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Papilloma viral infection 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Paronychia 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Pharyngeal chlamydia infection 1/147 (0.7%) 1 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Pharyngitis 1/147 (0.7%) 1 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Pharyngitis bacterial 2/147 (1.4%) 2 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Pharyngitis streptococcal 2/147 (1.4%) 2 5/151 (3.3%) 5 6/148 (4.1%) 6 2/148 (1.4%) 3
    Pneumonia 1/147 (0.7%) 1 1/151 (0.7%) 1 3/148 (2%) 3 3/148 (2%) 3
    Post procedural infection 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Postoperative wound infection 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Primary syphilis 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Proctitis bacterial 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Proctitis chlamydial 10/147 (6.8%) 11 2/151 (1.3%) 3 3/148 (2%) 4 5/148 (3.4%) 5
    Proctitis gonococcal 4/147 (2.7%) 4 5/151 (3.3%) 5 5/148 (3.4%) 5 3/148 (2%) 3
    Proctitis herpes 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Rash pustular 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 2
    Respiratory tract infection viral 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Secondary syphilis 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Sinusitis 5/147 (3.4%) 6 1/151 (0.7%) 1 2/148 (1.4%) 2 1/148 (0.7%) 1
    Sinusitis bacterial 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Skin infection 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Staphylococcal infection 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Subcutaneous abscess 1/147 (0.7%) 1 1/151 (0.7%) 1 1/148 (0.7%) 1 1/148 (0.7%) 1
    Syphilis 3/147 (2%) 3 2/151 (1.3%) 2 5/148 (3.4%) 5 3/148 (2%) 3
    Tinea cruris 0/147 (0%) 0 1/151 (0.7%) 2 0/148 (0%) 0 0/148 (0%) 0
    Tinea pedis 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Tinea versicolour 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Tonsillitis 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Tooth abscess 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Tooth infection 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Upper respiratory tract infection 3/147 (2%) 3 9/151 (6%) 10 6/148 (4.1%) 7 9/148 (6.1%) 9
    Urethritis 0/147 (0%) 0 2/151 (1.3%) 2 2/148 (1.4%) 2 0/148 (0%) 0
    Urethritis chlamydial 1/147 (0.7%) 2 6/151 (4%) 8 2/148 (1.4%) 2 3/148 (2%) 3
    Urethritis gonococcal 0/147 (0%) 0 2/151 (1.3%) 2 0/148 (0%) 0 1/148 (0.7%) 1
    Urinary tract infection 2/147 (1.4%) 2 5/151 (3.3%) 6 6/148 (4.1%) 8 2/148 (1.4%) 2
    Urinary tract infection bacterial 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Viral infection 1/147 (0.7%) 1 3/151 (2%) 3 3/148 (2%) 3 2/148 (1.4%) 2
    Viral pharyngitis 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Viral upper respiratory tract infection 8/147 (5.4%) 8 11/151 (7.3%) 12 6/148 (4.1%) 6 3/148 (2%) 3
    Vulvovaginal candidiasis 0/147 (0%) 0 2/151 (1.3%) 2 0/148 (0%) 0 2/148 (1.4%) 2
    Vulvovaginal mycotic infection 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Wound infection 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 2/148 (1.4%) 2
    Injury, poisoning and procedural complications
    Animal bite 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Arthropod bite 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Bone contusion 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Burns second degree 2/147 (1.4%) 2 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Chest injury 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Concussion 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Contusion 0/147 (0%) 0 0/151 (0%) 0 2/148 (1.4%) 2 0/148 (0%) 0
    Corneal abrasion 0/147 (0%) 0 2/151 (1.3%) 2 0/148 (0%) 0 0/148 (0%) 0
    Exposure to communicable disease 1/147 (0.7%) 2 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Eye contusion 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Eye injury 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Face injury 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Femur fracture 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Fibula fracture 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Foot fracture 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Fracture 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Hand fracture 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Human bite 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Injury 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Jaw fracture 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Joint dislocation 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Joint injury 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Laceration 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 4/148 (2.7%) 4
    Ligament sprain 1/147 (0.7%) 1 0/151 (0%) 0 2/148 (1.4%) 2 0/148 (0%) 0
    Limb injury 2/147 (1.4%) 2 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Lip injury 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Muscle strain 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Neck injury 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Overdose 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Post procedural contusion 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Post-traumatic neck syndrome 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Procedural dizziness 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Procedural headache 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Procedural nausea 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Procedural pain 2/147 (1.4%) 2 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Rib fracture 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Skin abrasion 0/147 (0%) 0 2/151 (1.3%) 2 0/148 (0%) 0 0/148 (0%) 0
    Spinal column injury 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Stress fracture 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Sunburn 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 3/148 (2%) 3
    Tendon injury 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Tooth fracture 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Traumatic iritis 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Ulna fracture 1/147 (0.7%) 2 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Upper limb fracture 2/147 (1.4%) 2 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Wrist fracture 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Investigations
    Alanine aminotransferase increased 1/147 (0.7%) 1 8/151 (5.3%) 10 5/148 (3.4%) 6 2/148 (1.4%) 3
    Aspartate aminotransferase increased 2/147 (1.4%) 2 7/151 (4.6%) 8 3/148 (2%) 3 4/148 (2.7%) 5
    Blood albumin decreased 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Blood bicarbonate decreased 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Blood bilirubin increased 2/147 (1.4%) 2 3/151 (2%) 3 2/148 (1.4%) 3 5/148 (3.4%) 8
    Blood cholesterol increased 1/147 (0.7%) 1 3/151 (2%) 3 6/148 (4.1%) 6 6/148 (4.1%) 6
    Blood creatine phosphokinase increased 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Blood creatinine increased 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 2/148 (1.4%) 2
    Blood glucose decreased 3/147 (2%) 3 2/151 (1.3%) 3 8/148 (5.4%) 9 3/148 (2%) 3
    Blood glucose increased 3/147 (2%) 6 5/151 (3.3%) 9 3/148 (2%) 3 7/148 (4.7%) 10
    Blood phosphorus decreased 9/147 (6.1%) 13 13/151 (8.6%) 13 11/148 (7.4%) 13 12/148 (8.1%) 17
    Blood phosphorus increased 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Blood potassium increased 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 1/148 (0.7%) 1
    Blood pressure decreased 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Blood pressure diastolic increased 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Blood pressure increased 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 2/148 (1.4%) 3
    Blood pressure systolic increased 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Blood triglycerides increased 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Carbon dioxide decreased 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Creatinine urine increased 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Haemoglobin decreased 2/147 (1.4%) 3 2/151 (1.3%) 2 0/148 (0%) 0 3/148 (2%) 4
    Lipids increased 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Low density lipoprotein increased 1/147 (0.7%) 1 4/151 (2.6%) 5 6/148 (4.1%) 7 6/148 (4.1%) 6
    Lymphocyte count decreased 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Neutrophil count decreased 2/147 (1.4%) 4 4/151 (2.6%) 6 2/148 (1.4%) 2 1/148 (0.7%) 1
    Protein urine present 1/147 (0.7%) 1 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Metabolism and nutrition disorders
    Abnormal loss of weight 2/147 (1.4%) 2 2/151 (1.3%) 2 0/148 (0%) 0 4/148 (2.7%) 5
    Decreased appetite 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Dehydration 2/147 (1.4%) 2 2/151 (1.3%) 2 0/148 (0%) 0 1/148 (0.7%) 1
    Diabetes mellitus 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Hypercholesterolaemia 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Hyperglycaemia 0/147 (0%) 0 2/151 (1.3%) 2 2/148 (1.4%) 3 1/148 (0.7%) 1
    Hyperlipidaemia 0/147 (0%) 0 1/151 (0.7%) 1 2/148 (1.4%) 4 1/148 (0.7%) 1
    Hypoglycaemia 3/147 (2%) 3 2/151 (1.3%) 2 4/148 (2.7%) 7 2/148 (1.4%) 2
    Hypokalaemia 3/147 (2%) 3 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Hypomagnesaemia 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Hyponatraemia 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 2 0/148 (0%) 0
    Hypophosphataemia 12/147 (8.2%) 21 15/151 (9.9%) 23 13/148 (8.8%) 19 7/148 (4.7%) 10
    Lactose intolerance 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Vitamin D deficiency 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/147 (2%) 4 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Arthritis 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Back pain 5/147 (3.4%) 6 4/151 (2.6%) 4 5/148 (3.4%) 5 2/148 (1.4%) 2
    Bone pain 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Costochondritis 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Flank pain 2/147 (1.4%) 2 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Intervertebral disc degeneration 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Intervertebral disc protrusion 1/147 (0.7%) 2 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Muscle spasms 0/147 (0%) 0 2/151 (1.3%) 2 0/148 (0%) 0 1/148 (0.7%) 1
    Muscular weakness 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Musculoskeletal chest pain 2/147 (1.4%) 2 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Musculoskeletal pain 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Musculoskeletal stiffness 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Myalgia 4/147 (2.7%) 4 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Neck pain 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 2/148 (1.4%) 2
    Pain in extremity 2/147 (1.4%) 2 1/151 (0.7%) 1 2/148 (1.4%) 2 2/148 (1.4%) 3
    Pain in jaw 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Rotator cuff syndrome 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Tendonitis 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acrochordon 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Anogenital warts 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Malignant melanoma 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Skin papilloma 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Uterine leiomyoma 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Nervous system disorders
    Amnesia 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Carpal tunnel syndrome 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Coordination abnormal 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Diabetic neuropathy 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Disturbance in attention 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Dizziness 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Dysarthria 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Facial paralysis 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Headache 8/147 (5.4%) 9 8/151 (5.3%) 8 6/148 (4.1%) 7 6/148 (4.1%) 7
    Hypoaesthesia 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Lethargy 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Loss of consciousness 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Migraine 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Motor dysfunction 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Paraesthesia 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Post-traumatic headache 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Presyncope 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Restless legs syndrome 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Syncope 0/147 (0%) 0 0/151 (0%) 0 2/148 (1.4%) 2 4/148 (2.7%) 4
    Tremor 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Psychiatric disorders
    Abnormal dreams 0/147 (0%) 0 2/151 (1.3%) 2 1/148 (0.7%) 1 0/148 (0%) 0
    Alcohol withdrawal syndrome 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Anxiety 5/147 (3.4%) 9 6/151 (4%) 6 5/148 (3.4%) 6 2/148 (1.4%) 3
    Bipolar disorder 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Confusional state 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Depression 2/147 (1.4%) 2 3/151 (2%) 5 2/148 (1.4%) 2 1/148 (0.7%) 1
    Depressive symptom 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Drug abuse 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Hallucination, auditory 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Insomnia 3/147 (2%) 3 1/151 (0.7%) 1 4/148 (2.7%) 4 1/148 (0.7%) 1
    Intentional self-injury 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Libido decreased 1/147 (0.7%) 1 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Mental disorder 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Mood swings 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Panic attack 1/147 (0.7%) 1 1/151 (0.7%) 1 1/148 (0.7%) 1 2/148 (1.4%) 2
    Post-traumatic stress disorder 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Stress 0/147 (0%) 0 2/151 (1.3%) 2 2/148 (1.4%) 2 1/148 (0.7%) 1
    Substance abuse 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Thinking abnormal 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Tobacco withdrawal symptoms 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Renal and urinary disorders
    Dysuria 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Glycosuria 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Haematuria 3/147 (2%) 3 3/151 (2%) 3 2/148 (1.4%) 3 1/148 (0.7%) 1
    Nephrolithiasis 1/147 (0.7%) 1 0/151 (0%) 0 2/148 (1.4%) 2 2/148 (1.4%) 2
    Nocturia 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Pollakiuria 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Proteinuria 8/147 (5.4%) 9 3/151 (2%) 3 4/148 (2.7%) 4 1/148 (0.7%) 1
    Renal colic 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Urethral discharge 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Reproductive system and breast disorders
    Breast pain 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Cervical dysplasia 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Erectile dysfunction 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Genital lesion 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Haematospermia 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Pelvic pain 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Penile discharge 0/147 (0%) 0 0/151 (0%) 0 2/148 (1.4%) 2 0/148 (0%) 0
    Penile pain 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Prostatitis 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 1/148 (0.7%) 1
    Pruritus genital 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Vaginal discharge 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Vulvovaginal dryness 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/147 (0.7%) 1 0/151 (0%) 0 3/148 (2%) 3 0/148 (0%) 0
    Cough 3/147 (2%) 3 2/151 (1.3%) 2 1/148 (0.7%) 1 1/148 (0.7%) 1
    Dysphonia 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Dyspnoea 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Epistaxis 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Hypoventilation 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Nasal congestion 1/147 (0.7%) 1 0/151 (0%) 0 4/148 (2.7%) 4 0/148 (0%) 0
    Oropharyngeal pain 3/147 (2%) 3 0/151 (0%) 0 2/148 (1.4%) 2 0/148 (0%) 0
    Pharyngeal inflammation 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Pleurisy 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Productive cough 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 1/148 (0.7%) 1
    Respiratory tract congestion 1/147 (0.7%) 1 2/151 (1.3%) 2 1/148 (0.7%) 1 2/148 (1.4%) 2
    Rhinitis allergic 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Sinus congestion 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Throat irritation 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Upper-airway cough syndrome 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Wheezing 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Skin and subcutaneous tissue disorders
    Acne 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Acne cystic 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Dandruff 0/147 (0%) 0 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Dermatitis 0/147 (0%) 0 1/151 (0.7%) 1 1/148 (0.7%) 1 0/148 (0%) 0
    Dermatitis contact 1/147 (0.7%) 1 1/151 (0.7%) 1 0/148 (0%) 0 0/148 (0%) 0
    Drug eruption 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Dry skin 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Eczema 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Hyperhidrosis 1/147 (0.7%) 1 0/151 (0%) 0 0/148 (0%) 0 0/148 (0%) 0
    Night sweats 0/147 (0%) 0 2/151 (1.3%) 2 0/148 (0%) 0 0/148 (0%) 0
    Pruritus 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Rash 2/147 (1.4%) 2 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Rash generalised 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Rash maculo-papular 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Rash pruritic 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 2/148 (1.4%) 2
    Skin lesion 0/147 (0%) 0 0/151 (0%) 0 0/148 (0%) 0 1/148 (0.7%) 1
    Skin ulcer 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 1/148 (0.7%) 1
    Urticaria 1/147 (0.7%) 1 1/151 (0.7%) 1 1/148 (0.7%) 1 1/148 (0.7%) 1
    Vascular disorders
    Hyperaemia 0/147 (0%) 0 0/151 (0%) 0 1/148 (0.7%) 1 0/148 (0%) 0
    Hypertension 2/147 (1.4%) 2 2/151 (1.3%) 2 2/148 (1.4%) 2 0/148 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

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

    All study abstracts and publications are subject to HPTN Publication and Public Information Policies and Clinical Trial Agreements between NIAID (DAIDS) and company collaborators. The publication or other disclosure can be delayed for up to thirty additional business days for manuscripts & five business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.

    Results Point of Contact

    Name/Title Chunyuan Wu
    Organization Fred Hutchinson cancer Research center
    Phone 206-667-5567
    Email cwu@scharp.org
    Responsible Party:
    National Institute of Allergy and Infectious Diseases (NIAID)
    ClinicalTrials.gov Identifier:
    NCT01505114
    Other Study ID Numbers:
    • HPTN 069/A5305 (NEXT Prep)
    • 11789
    • HPTN 069/A5305
    • HPTN 069
    • HPTN 069/NEXT Prep
    First Posted:
    Jan 6, 2012
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Jun 1, 2017