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HIV Screening

Submitted by administrator -
Abbreviation
HIV-Screen
Description

Ag&Ab enzyme immunoassay for qualitative determination of antigens or antibodies to HIV type 1 and/or type 2 in serum or plasma; and HIV-reactive IgG and IgM test using whole blood, serum, or plasma.

Category
Clinical Measures

CD4 T-cell Count

Submitted by administrator -
Abbreviation
CD4-Test
Description

Blood specimens sent to lab for CD4 testing using plasma samples; or on-site via PIMA POC CD4 analyzer (Alere Healthcare, USA) using venous whole blood samples.

Category
Clinical Measures
Division
DTMC
HEAL Study
No
Investigator(s)
Louis Cantilena, Jr., M.D, Ph.D.
Title
Double-blind, placebo-controlled, safety and pharmacology study with 75 mg dosage of GBR 12909 in cocaine experienced African American Volunteers.
Short Description
To assess the safety, tolerance, and pharmacokinetics of multiple dosages of 75mg oral GBR 12909 in cocaine experienced volunteers. Effects on WBC and ANC will be the primary hematology outcome measure.
Release Date
May 23, 2017
Description

This is a human laboratory study that will assess the clinical pharmacology, safety and tolerance of 75mg oral doses of GBR 12909, which is 1-[2-[bis(4-fluorophenyl)methoxy]ethyl]-4-(3-phenylpropyl) piperazine dihydrochloride, in cocaine experienced volunteers. Particular interest is being given to the hematological safety data.

Keywords
cocaine
gbr12909
phase 1b
stimulant
Assessments
Addiction Research Center Inventory
Blood Study Agent Level
Brief Substance Craving Scale
Change in Sexual Function Questionnaire
McLean Hospital Event Overt Aggression Checklist
Systematic Assessment for Treatment Emergent Effects
Accessibility Notice

Please note that the supplementary documents may not be fully Section 508 compliant. Please contact us for assistance.

Study Data
CPU-0005 Data
Study Links
ClinicalTrials.gov Link
CPU-0005 in NIH clinical trials registry
Study Documents
Protocol
CPU0005-Protocol.pdf
Dictionary
CPU0005-Dictionary.xlsx
Case Report Form(s)
CPU0005-CRF.pdf
Deidentification Notes
CPU0005-DeidentificationNotes.pdf
Nulled Values
CPU0005-NulledValues.csv
All Documents
CPU0005-AllDocuments.zip
Division
DTMC
HEAL Study
No
Investigator(s)
Kathryn Cunningham, Ph.D.
John Grabowski, Ph.D.
Title
Study of Interactions Between GBR 12909 and Cocaine
Short Description
This is a human laboratory clinical pharmacology study that will assess potential interactions between intravenous (i.v.) cocaine and three escalating oral doses (50, 70 and 100 mg) of GBR 12909, which is 1-[2-[bis(4-fluorophenyl)methoxy]ethyl]-4-(3-phenylpropyl) piperazine dihydrochloride.
Release Date
May 23, 2017
Description

The primary objective of this study is to determine safety of GBR 12909 administration and if there are significant interactions between GBR 12909 treatment concurrent with i.v. cocaine infusions of 20 and 40 mg by measuring adverse events and cardiovascular responses [heart rate (HR), blood pressure (BP), and electrocardiogram (ECG)]. Note: A significant interaction is defined as: more than 50% of the subjects treated with GBR 12909 experience a pharmacodynamic interaction when challenged with cocaine, which brings the stopping criteria (section 12.4.5) into effect.

Keywords
cocaine
gbr12909
interaction
phase 1b
stimulant
Assessments
Addiction Research Center Inventory
Barratt Impulsiveness Scale
Beck Depression Inventory
Blood Cocaine Level
Blood Study Agent Level
Brief Psychiatric Rating Scale
Brief Substance Craving Scale
Brief Symptom Inventory
ECG Monitoring
HIV Risk-Taking Behaviour Scale
Immediate Memory Task/Delayed Memory Task
Profile of Mood States
Visual Analog Scales
Vital Signs Monitoring
Accessibility Notice

Please note that the supplementary documents may not be fully Section 508 compliant. Please contact us for assistance.

Study Data
CPU-0004 Data
Study Links
ClinicalTrials.gov Link
CPU-0004 in NIH clinical trials registry
Study Documents
Protocol
CPU0004-Protocol.pdf
Dictionary
CPU0004-Dictionary.xlsx
Case Report Form(s)
CPU0004-CRF.pdf
Deidentification Notes
CPU0004-DeidentificationNotes.pdf
Nulled Values
CPU0004-NulledValues.csv
All Documents
CPU0004-AllDocuments.zip
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