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CompletedNCT00381303Updated Apr 21, 2014Results posted

GRACE: A Study to Compare the Effectiveness, Safety and Tolerability of PREZISTA (Darunavir)/Ritonavir by Gender and Race When Administered With Other Antiretroviral Medications in Human Immunodeficiency Virus (HIV) Positive Women and Men.

A Phase 3 interventional study of darunavir and ritonavir in HIV and Infectious, sponsored by Tibotec, Inc. Completed at 46 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-21.

Sponsored by Tibotec, Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
429
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate any differences in the effectiveness, safety, and tolerability of PREZISTA (darunavir; DRV) 600 mg, administered with ritonavir (RTV) 100 mg twice a day on virologic response (defined as a viral load (VL) of \< 50 copies/mL) over a 48-week treatment period in HIV-positive women and men. Additional antiretroviral (ARV) agents will also be administered and will be chosen by the Investigator based on resistance testing and prior treatment history (referred to as the Optimized Background Regimen (OBR)).

Read the detailed description

This is a multi-center, open-label (doctors and patients know which drug is being administered), Phase IIIb clinical trial to evaluate differences in effectiveness, safety, and tolerability of darunavir/ritonavir by sex and/or race over a 48-week treatment period. This study will be conducted in HIV positive women and men who have been treated previously with antiretroviral therapy. This study will enroll 70% women and will be conducted in the U.S., Puerto Rico, Mexico and Canada in approximately 420 patients who will receive darunavir 600 mg and ritonavir 100 mg twice daily. The primary objective of this study is to determine the percentage of patients who achieve virologic response, defined as a viral load (VL) of \<50 copies/mL at week 48. Secondary study objectives include comparisons of endpoints between women and men as well as race across multiple parameters including but not limited to change in CD4 count from baseline to week 48, time to loss of virologic response (TLOVR), changes in metabolic parameters (blood chemistry), etc.

Within 4 weeks after the Screening Visit (initial visit with investigator to determine eligibility), the Investigator should have received all data required to determine the patient's eligibility and will construct the individual Optimized Background Regimen (OBR) that will be used during the treatment period in combination with darunavir/ritonavir for those patients enrolled in the study. The OBR will consist of additional antiretroviral (ARV) agents that will also be administered during the study chosen by the Investigator and based on resistance testing and prior treatment history. The study Sponsor will provide the following ARV agents, that may be used as options for the OBR: TMC 125 (investigational non-nucleoside reverse transcriptase inhibitor; NNRTI); Truvada (tenofovir/emtricitabine); Viread (tenofovir); Emtriva (emtricitabine); Zidovudine. Other NRTIs (nucleoside reverse transcriptase inhibitors) or NNRTIs may be used at the discretion of the Investigator, but will not be provided by the Sponsor. The Baseline Visit (Day 1) will be followed by a 48-week treatment period during which patients will be evaluated at Weeks 4, 8, 12, 16, 24, 36, 48 and at a final Follow-Up Visit during Week 52. (total of 10 visits from Screening to final visit). At a number of visits throughout the study, blood samples will be obtained to assess defined laboratory values, safety parameters and to determine concentrations of study drugs darunavir, TMC125 (if applicable) and ritonavir). Patients will be assessed for change in CD4 count and HIV-RNA throughout the study. At each visit, vital signs will be assessed and patients will be asked about any untoward medical occurrences and these will be recorded as adverse events (AEs) and/or HIV-related events. Detailed definitions and reporting procedures for AEs will be provided as part of the protocol. Study patients will receive PREZISTA (darunavir) 600 mg boosted with 100 mg of ritonavir orally (by mouth) twice a day in combination with other antiretroviral drugs for 48 weeks.

02

Conditions studied

  • HIV
  • Infectious

Keywords

  • HIV
  • AIDS
  • Immunodeficiency Virus, Human
  • Females
  • Women
  • PREZISTA
  • darunavir
  • TMC114
  • Protease Inhibitor
03

In context

Communicable Diseases

4,452 studies on the registry are indexed under Communicable Diseases; 521 are open to participants now.

This study's enrollment of 429 is above the median of 122 across 2,718 interventional studies indexed under Communicable Diseases.

Browse Communicable Diseases studies →

Lead sponsor

Tibotec, Inc is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Documented HIV infection
  • Plasma HIV-RNA >= 1000 copies/mL
  • Must be able to comply with protocol requirements

Exclusion criteria

Exclusion Criteria:

  • No prior use of PREZISTA (darunavir), TMC125, enfuvirtide, or tipranavir
  • No currently active AIDS defining illness, Category C conditions according to the Center for Disease Control [CDC] Classification System for HIV Infection (1993) with the following exceptions, which must be discussed with the Sponsor prior to enrollment: stable cutaneous Kaposi's Sarcoma, Wasting syndrome due to HIV infection
  • Not currently using an investigational drug
  • Not pregnant or breastfeeding
  • No Grade 3 or 4 laboratory abnormality as defined by DAIDS (Division of AIDS, National Institute of Allergy and Infectious Diseases).
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
429 participants (actual)

Study arms

  • Experimental
    001

    darunavir 600mg bid for 48 wks,ritonavir 100mg bid for 48 wks

    Drug: darunavir · Drug: ritonavir

Interventions

  • Drugdarunavir

    600mg bid for 48 wks

  • Drugritonavir

    100mg bid for 48 wks

06

What researchers measure

Primary outcomes

  1. Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex

    TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability

    Time frame: Week 48

  2. Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex

    TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.

    Time frame: Week 48

Secondary outcomes

  1. Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race

    Intention to Treat population (ITT)

    Time frame: Week 48

  2. Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects

    The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)

    Time frame: Week 48

  3. Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race

    TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.

    Time frame: Week 48

  4. Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA

    The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR) TLOVR non-virologic failure(VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.

    Time frame: Week 48

  5. Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values

    Observed obsevations have no imputation methods applied.

    Time frame: Baseline, Week 48

  6. Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values

    The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)

    Time frame: Week 48

  7. Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)

    Last Observation Carried Forward (LOCF) imputation method applied.

    Time frame: Week 48

  8. Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF

    The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR). The Last Observation Carried Forward (LOCF) imputation method was applied.

    Time frame: Week 48

07

Results

Posted Oct 19, 2010

Participant flow

Participant flow — Overall Study
MilestoneFemaleMale
Started287142
Completed193109
Not completed9433
Withdrew: Lost to follow-up259
Withdrew: Ae/hiv-related event226
Withdrew: Non-adherence136
Withdrew: Withdrawal by subject136
Withdrew: Virologic failure64
Withdrew: Ineligible to continue the trial21
Withdrew: Pregnancy20
Withdrew: Physician decision10
Withdrew: Physician's decision to close the site31
Withdrew: Subject moved out of state20
Withdrew: Subject taking too many different meds10
Withdrew: No virologic response by week 1210
Withdrew: Subject was too busy for appointments10
Withdrew: Subject did not continue visits10
Withdrew: Subject primary physician's decision10

Outcome measures

PrimaryNumber of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex

TLOVR - responders/non-responders per FDA TLOVR response algorithm. A subject was considered a responder at that time point and that subsequent. A subject was considered a non-responder at a time point in the following situations: discontinued treatment at that time point, a rebound value at that time point and that subsequent or at that time point and that followed by treatment discontinuation, intermittent missing values were considered a response if the immediately preceding and following visits were a response, rebound at earlier time point, or any new, unplanned ARV except in tolerability

Time frame:
Week 48
Reported as:
Number · participants
Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex
participantsFemaleMale
Number of Viral Load (VL) < 50 HIV-1 RNA Copies/mL (Time to Loss of Virologic Response[TLOVR]) Subjects by Sex14683
Statistical analysis
  • Female vs Male · Regression, Logistic · p = 0.30 (P-Value for difference (Female - Male): Test for non-inferiority (Delta=15%)) · Mean difference (final values): -9.6 · 95% CI -19.85 to 0.68Estimates from logistic regression analysis include baseline log10 viral load and baseline CD4 cell count as covariates and gender as a factor.
SecondaryNumber of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race

Intention to Treat population (ITT)

Time frame:
Week 48
Reported as:
Number · participants
Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race
participantsBlackCaucasianHispanicAsianOther
Number of VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects by Race128395921
SecondaryNumber of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects

The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)

Time frame:
Week 48
Reported as:
Number · participants
Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects
participantsFemaleMaleBlackCaucasianHispanicAsianOther
Number of Etravirine-TMC125 (ETR) Subgroup- VL < 50 HIV-1 RNA Copies/mL (TLOVR) Subjects69 ± 0.08854 ± 0.13174 ± 0.09221 ± 0.19125 ± 0.1582 ± 0.4721 ± -1.73
SecondaryDescriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race

TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.

Time frame:
Week 48
Reported as:
Number · participants
Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race
participantsBlackCaucasianHispanicAsianOther
Descriptive Statistics of [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA by Race128395921
SecondaryDescriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA

The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR) TLOVR non-virologic failure(VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.

Time frame:
Week 48
Reported as:
Number · participants
Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA
participantsFemaleMaleBlackCaucasianHispanicAsianOther
Descriptive Statistics of ETR Subgroup [TLOVR Non-virologic Failure (VF) Censored] - VL < 50 HIV-1 RNA695474212521
SecondaryDescriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values

Observed obsevations have no imputation methods applied.

Time frame:
Baseline, Week 48
Reported as:
Mean · x10^6 cells/L
Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values
x10^6 cells/LFemaleMaleBlackCaucasianHispanicAsianOther
Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using Observed Values152 ± 11.2122 ± 12.3143 ± 10.8151 ± 23.8133 ± 17.045 ± 24.5179
SecondaryDescriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values

The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR)

Time frame:
Week 48
Reported as:
Mean · x10^6 cells/L
Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values
x10^6 cells/LFemaleMaleBlackCaucasianHispanicAsianOther
Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Using Observed Values136 ± 15.8108 ± 15.1135 ± 13.5111 ± 26.798 ± 29.845 ± 24.5179
SecondaryDescriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)

Last Observation Carried Forward (LOCF) imputation method applied.

Time frame:
Week 48
Reported as:
Mean · x10^6 cells/L
Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)
x10^6 cells/LFemaleMaleBlackCaucasianHispanicAsianOther
Descriptive Statistics of Change From Baseline in CD4+ Cell Count Using the Imputation Method of Last Observation Carried Forward (LOCF)112 ± 8.8103 ± 11.2109 ± 8.9110 ± 20.4109 ± 13.545 ± 24.5138 ± 41.0
PrimaryNumber of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex

TLOVR non-virologic failure (VF) censored. This imputation method differs from the TLOVR algorithm, because subjects that dropped out for reasons other than virologic failure were censored from the time of discontinuation onwards.

Time frame:
Week 48
Reported as:
Number · participants
Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex
participantsFemaleMale
Number of TLOVR Non-virologic Failure (VF) Censored - VL < 50 HIV-1 RNA Subjects by Sex14683
SecondaryDescriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF

The Etravirine-TMC125 (ETR Subgroup population was defined as all ITT subjects who took at least 1 dose of ETR). The Last Observation Carried Forward (LOCF) imputation method was applied.

Time frame:
Week 48
Reported as:
Mean · x10^6 Cells/L
Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF
x10^6 Cells/LFemaleMaleBlackCaucasianHispanicAsianOther
Descriptive Statistics of ETR Subgroup - Change From Baseline in CD4+ Cell Count Using the Imputation Method of LOCF107 ± 12.798 ± 14.0113 ± 12.184 ± 21.790 ± 22.645 ± 24.5138 ± 41.0

Adverse events

Collected over 48 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Female—47/287 (16.4%)73/287 (25.4%)
Male—33/142 (23.2%)33/142 (23.2%)
Most frequent serious events
Showing 10 of 101
Most frequent serious events
EventFemaleMale
PneumoniaInfections and infestations10/2871/142
Chest PainGeneral disorders0/2874/142
Pneumocystis Jiroveci PneumoniaInfections and infestations1/2874/142
Angina PectorisCardiac disorders2/2872/142
Myocardial InfarctionCardiac disorders2/2872/142
Non-Cardiac Chest PainGeneral disorders2/2872/142
Bacterial PyelonephritisInfections and infestations2/2872/142
CellulitisInfections and infestations2/2872/142
DepressionPsychiatric disorders2/2872/142
Suicide AttemptPsychiatric disorders2/2872/142
Most frequent other events
Showing 10 of 16
Most frequent other events
EventFemaleMale
NauseaGastrointestinal disorders70/28720/142
DiarrhoeaGastrointestinal disorders47/28731/142
VomitingGastrointestinal disorders33/2879/142
Upper Respiratory Tract InfectionInfections and infestations30/28711/142
CoughRespiratory, thoracic and mediastinal disorders27/28712/142
HeadacheNervous system disorders26/28711/142
PyrexiaGeneral disorders14/28712/142
RashSkin and subcutaneous tissue disorders23/28711/142
Back PainMusculoskeletal and connective tissue disorders16/28711/142
DepressionPsychiatric disorders15/28710/142

Baseline characteristics

Age, Continuous
Age, Continuous(years)FemaleMaleTotal
Median43 (19 to 78)45 (21 to 78)43 (19 to 78)
Sex: Female, Male
Sex: Female, Male(Participants)FemaleMaleTotal
Female2870287
Male0142142
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)FemaleMaleTotal
Black19173264
Caucasian/White343165
Hispanic603696
Asian022
Other202
Previous Antiretroviral (ARV) Experience: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
Previous Antiretroviral (ARV) Experience: Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)(participants)FemaleMaleTotal
NNRTI: < 1 drug count8332115
NNRTI: >= 1 drug count204110314
Previous ARV experience: Protease inhibitor (PI)
Previous ARV experience: Protease inhibitor (PI)(participants)FemaleMaleTotal
PI: <211950169
PI: >=216892260
CD4+ cell count
CD4+ cell count(cells/L)FemaleMaleTotal
Median210 (1 to 868)175 (2 to 1125)200 (1 to 1125)
Plasma log10 copies/mL VL HIV-1 RNA
Plasma log10 copies/mL VL HIV-1 RNA(copies/mL)FemaleMaleTotal
Mean4.65 ± 0.8834.73 ± 0.8564.67 ± 0.874
Time since HIV-infection diagnosis
Time since HIV-infection diagnosis(years)FemaleMaleTotal
Median10.78 (0.29 to 27.62)11.91 (1.21 to 23.76)11.3 (0.29 to 27.62)
08

Study locations

46 sites
  • Birmingham, Alabama, United States
  • Phoenix, Arizona, United States
  • Los Angeles, California, United States
  • Sacramento, California, United States
  • Torrance, California, United States
  • Washington, District of Columbia, United States
  • Fort Lauderdale, Florida, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • North Palm Beach, Florida, United States
  • Orlando, Florida, United States
  • Pensacola, Florida, United States
  • Port St Lucie, Florida, United States
  • West Palm Beach, Florida, United States
  • Atlanta, Georgia, United States
  • Savannah, Georgia, United States
  • Chicago, Illinois, United States
  • Kansas City, Kansas, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Springfield, Massachusetts, United States
  • Detroit, Michigan, United States
  • Saint Louis, Missouri, United States
  • Neptune, New Jersey, United States
  • Newark, New Jersey, United States
  • Bronx, New York, United States
  • New York, New York, United States
  • Chapel Hill, North Carolina, United States
  • Durham, North Carolina, United States
  • Winston-Salem, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Austin, Texas, United States
  • Dallas, Texas, United States
  • Harlingen, Texas, United States
  • Houston, Texas, United States
  • Longview, Texas, United States
  • San Antonio, Texas, United States
  • Salt Lake City, Utah, United States
  • Charlottesville, Virginia, United States
  • Hamilton, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Ponce, Puerto Rico
  • Rio Piedras, Puerto Rico
09

References and documents

Publications

  • Tsoukas C, Gilbert L, Lewis T, Hatzakis G, Falcon R, Mrus J. Improvements in Immune Function and Activation with 48-Week Darunavir/Ritonavir-Based Therapy: GRACE Substudy. ISRN AIDS. 2013 Dec 12;2013:358294. doi: 10.1155/2013/358294. eCollection 2013. PubMed 24396625 ↗
  • Smith KY, Garcia F, Kumar P, Currier JS, Ryan R, Falcon R, Mrus J, Squires K. Assessing darunavir/ritonavir-based therapy in a racially diverse population: 48-week outcomes from GRACE. J Natl Med Assoc. 2012 Jul-Aug;104(7-8):366-76. doi: 10.1016/s0027-9684(15)30179-6. PubMed 23092052 ↗
  • Currier J, Averitt Bridge D, Hagins D, Zorrilla CD, Feinberg J, Ryan R, Falcon R, Tennenberg A, Mrus J, Squires K; GRACE (Gender, Race, And Clinical Experience) Study Group. Sex-based outcomes of darunavir-ritonavir therapy: a single-group trial. Ann Intern Med. 2010 Sep 21;153(6):349-57. doi: 10.7326/0003-4819-153-6-201009210-00002. PubMed 20855799 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00381303
Lead sponsor
Tibotec, Inc
Collaborators
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Responsible party
Sponsor
First posted
Sep 27, 2006
Start date
Nov 2006
Primary completion
Nov 2008
Completion
Dec 2008
Results posted
Oct 19, 2010
Last update
Apr 21, 2014

Study contacts

Tibotec, Inc. Clinical Trial
study director · Tibotec, Inc

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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