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.
This study has been completed.
Sponsor:
Community Research Initiative of New England
Collaborators:
Bristol-Myers Squibb
Merck
Information provided by (Responsible Party):
Cal Cohen, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00931801
First received: June 30, 2009
Last updated: March 14, 2013
Last verified: March 2013
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Results First Received: February 5, 2013
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
HIV |
| Interventions: |
Drug: atazanavir/raltegravir Drug: atazanavir/tenofovir/emtricitabine |
Participant Flow
Recruitment Details
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| 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
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 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. |
Reporting Groups
| Description | |
|---|---|
| Control Arm | atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine |
| Intervention Arm No.1 | atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily |
| Intervention Arm No.2 | atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily |
Participant Flow: Overall Study
| Control Arm | Intervention Arm No.1 | Intervention Arm No.2 | |
|---|---|---|---|
| STARTED | 14 | 15 | 14 |
| COMPLETED | 13 | 14 | 10 |
| NOT COMPLETED | 1 | 1 | 4 |
| Adverse Event | 0 | 0 | 1 |
| Lost to Follow-up | 0 | 1 | 0 |
| Withdrawal by Subject | 1 | 0 | 0 |
| Confirmed Virologic Failure | 0 | 0 | 3 |
Baseline Characteristics
Reporting Groups
| Description | |
|---|---|
| Control Arm | atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine |
| Intervention Arm No.1 | atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily |
| Intervention Arm No.2 | atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily |
| Total | Total of all reporting groups |
Baseline Measures
| Control Arm | Intervention Arm No.1 | Intervention Arm No.2 | Total | |
|---|---|---|---|---|
|
Number of Participants
[units: participants] |
14 | 15 | 14 | 43 |
|
Age
[units: years] Mean ± Standard Deviation |
43.5 ± 11.6 | 47.6 ± 11.5 | 46.6 ± 6.6 | 45.9 ± 10.1 |
|
Gender
[units: participants] |
||||
| Female | 2 | 2 | 1 | 5 |
| Male | 12 | 13 | 13 | 38 |
|
Ethnicity (NIH/OMB)
[units: participants] |
||||
| Hispanic or Latino | 6 | 2 | 5 | 13 |
| Not Hispanic or Latino | 8 | 13 | 9 | 30 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
|
Race (NIH/OMB)
[units: participants] |
||||
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 0 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 3 | 3 | 3 | 9 |
| White | 9 | 12 | 11 | 32 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
|
Region of Enrollment
[units: participants] |
||||
| United States | 14 | 15 | 14 | 43 |
|
Mean CD4
[units: cells/mm3] Mean ± Standard Deviation |
544.6 ± 197.7 | 518.5 ± 198.9 | 533.9 ± 198.3 | 532.0 ± 193.8 |
Outcome Measures
| 1. Primary: | Maintenance of Virologic Suppression [ Time Frame: 48 weeks ] |
| 2. Secondary: | The Difference in CD4 From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] |
| 3. Secondary: | The Change in Adherence to Study Treatment Arm From Baseline to Week 48 [ Time Frame: Baseline and Week 48 ] |
| 4. Secondary: | Change in Quality of Life From Baseline to 48 Weeks of Study Treatment [ Time Frame: baseline and 48 weeks ] |
Serious Adverse Events Other Adverse Events
| Time Frame | 48 Weeks |
|---|---|
| Additional Description | No text entered. |
Frequency Threshold
| Threshold above which other adverse events are reported | 0% |
|---|
Reporting Groups
| Description | |
|---|---|
| Control Arm | Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine |
| Intervention Arm No.1 | switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily |
| Intervention Arm No.2 | switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily |
| Total | All study arms combined |
Other Adverse Events
| Control Arm | Intervention Arm No.1 | Intervention Arm No.2 | Total | |
|---|---|---|---|---|
| Total, other (not including serious) adverse events | ||||
| # participants affected / at risk | 9/14 | 13/15 | 13/14 | 35/43 |
| Blood and lymphatic system disorders | ||||
| hypertophy of tonsils † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| lymphadenopathy † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 1/14 (7.14%) | 2/43 (4.65%) |
| # events | 0 | 1 | 1 | 2 |
| Cardiac disorders | ||||
| chest pain † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| ECG changes † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| hypertension † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 1/14 (7.14%) | 2/43 (4.65%) |
| # events | 0 | 1 | 1 | 2 |
| palpitations without chest pain † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| Ear and labyrinth disorders | ||||
| eustacian tube dysfunction † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| Endocrine disorders | ||||
| hypogonadism † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| Eye disorders | ||||
| visual disturbance † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| vitreous detachment † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| Gastrointestinal disorders | ||||
| abdominal pain † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| apthous ulcer † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| changes to bowel movements † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| constipation † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| dental pain † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| diarrhea † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 3/15 (20.00%) | 3/14 (21.43%) | 6/43 (13.95%) |
| # events | 0 | 3 | 3 | 6 |
| dry throat † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| dyspepsia † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| feeling full upon awakening † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| flatulence † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 1/14 (7.14%) | 2/43 (4.65%) |
| # events | 0 | 1 | 1 | 2 |
| gastroesophageal reflux disease † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 2/14 (14.29%) | 3/43 (6.98%) |
| # events | 0 | 1 | 2 | 3 |
| GI disturbance † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| gingivitis † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| heart burn † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| nausea † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| Pharyngitis † | ||||
| # participants affected / at risk | 2/14 (14.29%) | 1/15 (6.67%) | 2/14 (14.29%) | 5/43 (11.63%) |
| # events | 2 | 1 | 2 | 5 |
| tooth abscess † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| General disorders | ||||
| Fatigue † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 2/14 (14.29%) | 3/43 (6.98%) |
| # events | 1 | 0 | 2 | 3 |
| Nightsweats † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| Thirst † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| weight gain † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| Infections and infestations | ||||
| conjunctivitis † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| Gastroenteritis † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| influenza like illness † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 1/14 (7.14%) | 2/43 (4.65%) |
| # events | 0 | 1 | 1 | 2 |
| latent mycobacterium tuberculosis Infection † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| scabies † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| Sinusitis † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| STI † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 2/15 (13.33%) | 2/14 (14.29%) | 5/43 (11.63%) |
| # events | 1 | 2 | 2 | 5 |
| Injury, poisoning and procedural complications | ||||
| bone fracture † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| facial laceration † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 2/15 (13.33%) | 0/14 (0.00%) | 2/43 (4.65%) |
| # events | 0 | 2 | 0 | 2 |
| leg pain † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| arthralgia † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| gout † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| lower back pain † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 2/14 (14.29%) | 2/43 (4.65%) |
| # events | 0 | 0 | 2 | 2 |
| lower extremity ache † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| lower extremity pain † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 2/14 (14.29%) | 2/43 (4.65%) |
| # events | 0 | 0 | 2 | 2 |
| neck pain † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| popliteal cyst † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| shoulder pain † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 1/14 (7.14%) | 2/43 (4.65%) |
| # events | 0 | 1 | 1 | 2 |
| Nervous system disorders | ||||
| Dizziness † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 1/14 (7.14%) | 2/43 (4.65%) |
| # events | 0 | 1 | 1 | 2 |
| Headache † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 3/15 (20.00%) | 2/14 (14.29%) | 6/43 (13.95%) |
| # events | 1 | 3 | 2 | 6 |
| insomnia † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 2/14 (14.29%) | 3/43 (6.98%) |
| # events | 0 | 1 | 2 | 3 |
| light headedness † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| paresthesias † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| vivid dreams † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| Psychiatric disorders | ||||
| Anxiety † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| Depression † | ||||
| # participants affected / at risk | 2/14 (14.29%) | 1/15 (6.67%) | 1/14 (7.14%) | 4/43 (9.30%) |
| # events | 2 | 1 | 1 | 4 |
| Renal and urinary disorders | ||||
| Dysuria † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 1/15 (6.67%) | 0/14 (0.00%) | 2/43 (4.65%) |
| # events | 1 | 1 | 0 | 2 |
| Renal Calculus † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| Urinary Tract Infection † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| Reproductive system and breast disorders | ||||
| Erectile dysfunction † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Allergic Rhinitis † | ||||
| # participants affected / at risk | 2/14 (14.29%) | 2/15 (13.33%) | 0/14 (0.00%) | 4/43 (9.30%) |
| # events | 2 | 2 | 0 | 4 |
| Bronchitis † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 3/15 (20.00%) | 1/14 (7.14%) | 4/43 (9.30%) |
| # events | 0 | 3 | 2 | 5 |
| Cough † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| Sinus Pressure † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| Upper Respiratory Congestion † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 2/14 (14.29%) | 3/43 (6.98%) |
| # events | 1 | 0 | 2 | 3 |
| Upper Respiratory Infection † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 3/14 (21.43%) | 4/43 (9.30%) |
| # events | 0 | 2 | 3 | 5 |
| Skin and subcutaneous tissue disorders | ||||
| Abscess † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 1/15 (6.67%) | 1/14 (7.14%) | 3/43 (6.98%) |
| # events | 1 | 2 | 1 | 4 |
| Angular Chelitis † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| Cutaneous Sarcoidosis, worsening † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| Dermatitis † | ||||
| # participants affected / at risk | 2/14 (14.29%) | 0/15 (0.00%) | 0/14 (0.00%) | 2/43 (4.65%) |
| # events | 2 | 0 | 0 | 2 |
| Dry Skin † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 1/14 (7.14%) | 1/43 (2.33%) |
| # events | 0 | 0 | 1 | 1 |
| Folliculitis † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 1/15 (6.67%) | 0/14 (0.00%) | 2/43 (4.65%) |
| # events | 1 | 1 | 0 | 2 |
| Groin Itch † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 1/15 (6.67%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 0 | 1 | 0 | 1 |
| loose nails - bilateral halux † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 0/15 (0.00%) | 0/14 (0.00%) | 1/43 (2.33%) |
| # events | 1 | 0 | 0 | 1 |
| Skin Lesion † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 1/15 (6.67%) | 0/14 (0.00%) | 2/43 (4.65%) |
| # events | 1 | 1 | 0 | 2 |
| Skin Rash, unspecified † | ||||
| # participants affected / at risk | 2/14 (14.29%) | 1/15 (6.67%) | 1/14 (7.14%) | 4/43 (9.30%) |
| # events | 2 | 1 | 1 | 4 |
| Tinea Cruris † | ||||
| # participants affected / at risk | 0/14 (0.00%) | 0/15 (0.00%) | 2/14 (14.29%) | 2/43 (4.65%) |
| # events | 0 | 0 | 2 | 2 |
| Social circumstances | ||||
| Substance Misuse † | ||||
| # participants affected / at risk | 1/14 (7.14%) | 1/15 (6.67%) | 0/14 (0.00%) | 2/43 (4.65%) |
| # events | 1 | 1 | 0 | 2 |
| † | Events were collected by systematic assessment |
|---|
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
Limitations and Caveats
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| No text entered. |
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
e-mail: ccohen@crine.org
Organization: Community Research Initiative of New England
phone: 617-502-1700
e-mail: ccohen@crine.org
No publications provided
| Responsible Party: | Cal Cohen, Community Research Initiative of New England |
| ClinicalTrials.gov Identifier: | NCT00931801 History of Changes |
| Other Study ID Numbers: | 09-102 |
| Study First Received: | June 30, 2009 |
| Results First Received: | February 5, 2013 |
| Last Updated: | March 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |