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BATAR: Individuals Currently Taking Boosted Atazanavir as Part of an HIV Treatment Regimen Will be Evaluated to See if Substituting Raltegravir for Nucleoside Transcriptase Inhibitors Will be Safe and Well Tolerated. (BATAR)

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ClinicalTrials.gov Identifier: NCT00931801
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : March 11, 2013
Last Update Posted : July 21, 2017
Sponsor:
Collaborators:
Bristol-Myers Squibb
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Community Research Initiative of New England

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV
Interventions Drug: atazanavir/raltegravir
Drug: atazanavir/tenofovir/emtricitabine
Enrollment 43
Recruitment Details Recruitment was initiated on 15 APR 2010 and enrolled subjects through 31 JAN 2011. Recruitment and screening took place at 10 participating sites (9 medical clinics and 1 clinical research organization). 43 subjects were enrolled.
Pre-assignment Details There were 7 participants that did not meet eligibility criteria (either due to disallowed concomitant medication use or safety labs outside of the required parameters). 2 of those 7 subjects re-screened at a later date and were confirmed eligible. 2 subjects withdrew consent after the screening visit but prior to starting the assigned treatment.
Arm/Group Title Control Arm Intervention Arm No.1 Intervention Arm No.2
Hide Arm/Group Description atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Period Title: Overall Study
Started 14 15 14
Completed 13 14 10
Not Completed 1 1 4
Reason Not Completed
Adverse Event             0             0             1
Lost to Follow-up             0             1             0
Withdrawal by Subject             1             0             0
Confirmed Virologic Failure             0             0             3
Arm/Group Title Control Arm Intervention Arm No.1 Intervention Arm No.2 Total
Hide Arm/Group Description atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily Total of all reporting groups
Overall Number of Baseline Participants 14 15 14 43
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 15 participants 14 participants 43 participants
43.5  (11.6) 47.6  (11.5) 46.6  (6.6) 45.9  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 14 participants 43 participants
Female
2
  14.3%
2
  13.3%
1
   7.1%
5
  11.6%
Male
12
  85.7%
13
  86.7%
13
  92.9%
38
  88.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 14 participants 43 participants
Hispanic or Latino
6
  42.9%
2
  13.3%
5
  35.7%
13
  30.2%
Not Hispanic or Latino
8
  57.1%
13
  86.7%
9
  64.3%
30
  69.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 15 participants 14 participants 43 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   7.1%
0
   0.0%
0
   0.0%
1
   2.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  21.4%
3
  20.0%
3
  21.4%
9
  20.9%
White
9
  64.3%
12
  80.0%
11
  78.6%
32
  74.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   7.1%
0
   0.0%
0
   0.0%
1
   2.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 15 participants 14 participants 43 participants
14 15 14 43
Mean CD4  
Mean (Standard Deviation)
Unit of measure:  Cells/mm3
Number Analyzed 14 participants 15 participants 14 participants 43 participants
544.6  (197.7) 518.5  (198.9) 533.9  (198.3) 532.0  (193.8)
1.Primary Outcome
Title Maintenance of Virologic Suppression
Hide Description To evaluate and compare maintenance of virologic suppression with raltegravir (RAL) 400mg 2x daily plus atazanavir (ATV) dosed either as ATV/ritonavir (RTV)300/100mg 1x daily or ATV 300mg 2x daily in subjects with virologic suppression on a standard regimen of ATV/RTV plus Truvada. Virologic suppression is defined as HIV RNA < 40 copies/mL.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All enrolled participants were included in this analysis of primary outcome measurement.
Arm/Group Title Control Arm Intervention Arm No.1 Intervention Arm No.2
Hide Arm/Group Description:
Continue baseline regimen of atazanavir/ritonavir 300/100mg once daily plus tenofovir and emtricitabine
switch to atazanavir/ritonavir 300/100mg once daily plus raltegravir 400mg twice daily
switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
Overall Number of Participants Analyzed 14 15 14
Measure Type: Number
Unit of Measure: participants
Virologic Response 13 14 10
Confirmed Virologic Failures 0 0 3
Withdrawal Due to AE; HIV RNA < 50 copies/mL 0 0 1
Other Withdrawal; HIV RNA < 50 copies/mL 1 1 0
2.Secondary Outcome
Title The Difference in CD4 From Baseline to Week 48
Hide Description Change in mean CD4 from Baseline to Week 48.
Time Frame Baseline and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or lab error.
Arm/Group Title Control Arm Intervention Arm No.1 Intervention Arm No.2 Total
Hide Arm/Group Description:
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
All study arms combined
Overall Number of Participants Analyzed 12 14 10 36
Mean (Standard Deviation)
Unit of Measure: cells/mm3
CD4 at Baseline 535.8  (210.9) 514.1  (205.7) 539.1  (206.2) 528.3  (201.9)
CD4 at Week 48 611.2  (218.1) 526.3  (210.5) 507.2  (201.7) 549.3  (209.5)
CD4 Change 75.4  (133.9) 12.1  (96.4) -31.9  (122.0) 21.0  (121.5)
3.Secondary Outcome
Title The Change in Adherence to Study Treatment Arm From Baseline to Week 48
Hide Description Adherence to study treatment reported as the percentage of doses of the prescribed treatment arm regimen taken, described by each subject through recall of dosing in the three days prior to the visit Baseline and Week 48 vistis. The change in adherence is reflected as the difference of the mean percentage of adherence per arm between Baseline and Week 48 visits.
Time Frame Baseline and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Values included for all enrolled participants excluding participants with confirmed virologic failure or those missing values due to early withdrawal, loss to follow-up or other error.
Arm/Group Title Control Arm Intervention Arm No.1 Intervention Arm No.2 Total
Hide Arm/Group Description:
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
All study arms combined
Overall Number of Participants Analyzed 12 13 10 35
Mean (Standard Deviation)
Unit of Measure: percentage of prescribed doses
3 Day Adherence Recall at Baseline 100  (0) 97.5  (9.2) 96.7  (10.4) 98.1  (7.8)
3 Day Adherence Recall at Week 48 100  (0) 97.5  (9.2) 95.0  (15.8) 97.6  (10)
Change in 3 Day Adherence Recall 0  (0) 0  (13.5) -1.7  (19.9) -0.5  (13)
4.Secondary Outcome
Title Change in Quality of Life From Baseline to 48 Weeks of Study Treatment
Hide Description Quality of Life was measured by self report using a standardized scale, where 0 is death and 100 is perfect health. The baseline measure was obtained prior to initiation of study treatment arm. The week 48 measure captures Quality of Life by self report at 48 weeks of study treatment.
Time Frame baseline and 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data for all participants assigned to a study treatment was analyzed except data for participants that did not have both baseline and week 48 data, including early withdrawal, virologic failure, loss to follow-up or missing data.
Arm/Group Title Control Arm Intervention Arm No.1 Intervention Arm No.2 Total
Hide Arm/Group Description:
Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
All study arms combined
Overall Number of Participants Analyzed 11 12 8 31
Mean (Standard Deviation)
Unit of Measure: units on a scale
Mean Quality of Life Score at Baseline 92.9  (8.6) 77.4  (16.1) 82.5  (11.6) 84.2  (14.1)
Mean Quality of Life Score at Week 48 90.5  (11.1) 78.2  (22.6) 81.3  (17.5) 83.3  (18.2)
Change in Quality of Life -2.5  (8.2) 0.8  (20.0) -1.3  (12.7) -0.9  (14.4)
Time Frame 48 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Arm Intervention Arm No.1 Intervention Arm No.2 Total
Hide Arm/Group Description Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily All study arms combined
All-Cause Mortality
Control Arm Intervention Arm No.1 Intervention Arm No.2 Total
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control Arm Intervention Arm No.1 Intervention Arm No.2 Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      2/15 (13.33%)      2/14 (14.29%)      5/43 (11.63%)    
Blood and lymphatic system disorders         
Deep Vein Thrombosis   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
Cardiac disorders         
Myocardial Infarction *  1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Prostate Cancer   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Psychiatric disorders         
Hospitalization for Recurrent Depression   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders         
Hospitalization due to asthma   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Arm Intervention Arm No.1 Intervention Arm No.2 Total
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/14 (64.29%)      13/15 (86.67%)      13/14 (92.86%)      35/43 (81.40%)    
Blood and lymphatic system disorders         
hypertophy of tonsils   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
lymphadenopathy   0/14 (0.00%)  0 1/15 (6.67%)  1 1/14 (7.14%)  1 2/43 (4.65%)  2
Cardiac disorders         
chest pain   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
ECG changes   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
hypertension   0/14 (0.00%)  0 1/15 (6.67%)  1 1/14 (7.14%)  1 2/43 (4.65%)  2
palpitations without chest pain   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
Ear and labyrinth disorders         
eustacian tube dysfunction   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
Endocrine disorders         
hypogonadism   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
Eye disorders         
visual disturbance   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
vitreous detachment   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Gastrointestinal disorders         
abdominal pain   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
apthous ulcer   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
changes to bowel movements   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
constipation   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
dental pain   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
diarrhea   0/14 (0.00%)  0 3/15 (20.00%)  3 3/14 (21.43%)  3 6/43 (13.95%)  6
dry throat   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
dyspepsia   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
feeling full upon awakening   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
flatulence   0/14 (0.00%)  0 1/15 (6.67%)  1 1/14 (7.14%)  1 2/43 (4.65%)  2
gastroesophageal reflux disease   0/14 (0.00%)  0 1/15 (6.67%)  1 2/14 (14.29%)  2 3/43 (6.98%)  3
GI disturbance   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
gingivitis   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
heart burn   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
nausea   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
Pharyngitis   2/14 (14.29%)  2 1/15 (6.67%)  1 2/14 (14.29%)  2 5/43 (11.63%)  5
tooth abscess   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
General disorders         
Fatigue   1/14 (7.14%)  1 0/15 (0.00%)  0 2/14 (14.29%)  2 3/43 (6.98%)  3
Nightsweats   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
Thirst   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
weight gain   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Infections and infestations         
conjunctivitis   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
Gastroenteritis   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
influenza like illness   0/14 (0.00%)  0 1/15 (6.67%)  1 1/14 (7.14%)  1 2/43 (4.65%)  2
latent mycobacterium tuberculosis Infection   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
scabies   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Sinusitis   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
STI   1/14 (7.14%)  1 2/15 (13.33%)  2 2/14 (14.29%)  2 5/43 (11.63%)  5
Injury, poisoning and procedural complications         
bone fracture   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
facial laceration   0/14 (0.00%)  0 2/15 (13.33%)  2 0/14 (0.00%)  0 2/43 (4.65%)  2
leg pain   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Musculoskeletal and connective tissue disorders         
arthralgia   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
gout   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
lower back pain   0/14 (0.00%)  0 0/15 (0.00%)  0 2/14 (14.29%)  2 2/43 (4.65%)  2
lower extremity ache   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
lower extremity pain   0/14 (0.00%)  0 0/15 (0.00%)  0 2/14 (14.29%)  2 2/43 (4.65%)  2
neck pain   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
popliteal cyst   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
shoulder pain   0/14 (0.00%)  0 1/15 (6.67%)  1 1/14 (7.14%)  1 2/43 (4.65%)  2
Nervous system disorders         
Dizziness   0/14 (0.00%)  0 1/15 (6.67%)  1 1/14 (7.14%)  1 2/43 (4.65%)  2
Headache   1/14 (7.14%)  1 3/15 (20.00%)  3 2/14 (14.29%)  2 6/43 (13.95%)  6
insomnia   0/14 (0.00%)  0 1/15 (6.67%)  1 2/14 (14.29%)  2 3/43 (6.98%)  3
light headedness   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
paresthesias   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
vivid dreams   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Psychiatric disorders         
Anxiety   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Depression   2/14 (14.29%)  2 1/15 (6.67%)  1 1/14 (7.14%)  1 4/43 (9.30%)  4
Renal and urinary disorders         
Dysuria   1/14 (7.14%)  1 1/15 (6.67%)  1 0/14 (0.00%)  0 2/43 (4.65%)  2
Renal Calculus   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Urinary Tract Infection   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
Reproductive system and breast disorders         
Erectile dysfunction   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders         
Allergic Rhinitis   2/14 (14.29%)  2 2/15 (13.33%)  2 0/14 (0.00%)  0 4/43 (9.30%)  4
Bronchitis   0/14 (0.00%)  0 3/15 (20.00%)  3 1/14 (7.14%)  2 4/43 (9.30%)  5
Cough   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Sinus Pressure   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
Upper Respiratory Congestion   1/14 (7.14%)  1 0/15 (0.00%)  0 2/14 (14.29%)  2 3/43 (6.98%)  3
Upper Respiratory Infection   0/14 (0.00%)  0 1/15 (6.67%)  2 3/14 (21.43%)  3 4/43 (9.30%)  5
Skin and subcutaneous tissue disorders         
Abscess   1/14 (7.14%)  1 1/15 (6.67%)  2 1/14 (7.14%)  1 3/43 (6.98%)  4
Angular Chelitis   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Cutaneous Sarcoidosis, worsening   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
Dermatitis   2/14 (14.29%)  2 0/15 (0.00%)  0 0/14 (0.00%)  0 2/43 (4.65%)  2
Dry Skin   0/14 (0.00%)  0 0/15 (0.00%)  0 1/14 (7.14%)  1 1/43 (2.33%)  1
Folliculitis   1/14 (7.14%)  1 1/15 (6.67%)  1 0/14 (0.00%)  0 2/43 (4.65%)  2
Groin Itch   0/14 (0.00%)  0 1/15 (6.67%)  1 0/14 (0.00%)  0 1/43 (2.33%)  1
loose nails - bilateral halux   1/14 (7.14%)  1 0/15 (0.00%)  0 0/14 (0.00%)  0 1/43 (2.33%)  1
Skin Lesion   1/14 (7.14%)  1 1/15 (6.67%)  1 0/14 (0.00%)  0 2/43 (4.65%)  2
Skin Rash, unspecified   2/14 (14.29%)  2 1/15 (6.67%)  1 1/14 (7.14%)  1 4/43 (9.30%)  4
Tinea Cruris   0/14 (0.00%)  0 0/15 (0.00%)  0 2/14 (14.29%)  2 2/43 (4.65%)  2
Social circumstances         
Substance Misuse   1/14 (7.14%)  1 1/15 (6.67%)  1 0/14 (0.00%)  0 2/43 (4.65%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Calvin J. Cohen MD, MSc, Director of Research
Organization: Community Research Initiative of New England
Phone: 617-502-1700
Responsible Party: Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00931801     History of Changes
Other Study ID Numbers: 09-102
First Submitted: June 30, 2009
First Posted: July 2, 2009
Results First Submitted: February 5, 2013
Results First Posted: March 11, 2013
Last Update Posted: July 21, 2017