Contact Information

Phone: (650) 522-5301
Fax: (650) 522-4813
Email: Phase4@gilead.com

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Study Location

Date: 04/23/2014
Country United States

Study Title

Study Title *

Study Product *

Adefovir (Hepsera®)

Ambrisentan (Letairis®)

Aztreonam for inhalation solution (Cayston®)

Emtricitabine (FTC; Emtriva®)

EVG + COBI + FTC + TDF (STRIBILD®)

Ranolazine (Ranexa®)

Tenofovir DF (TDF; Viread®), HBV
Tenofovir DF (TDF; Viread®), HIV

TDF + FTC (Truvada®)

TDF + FTC (Truvada® for PrEP)

TDF + FTC + EFV (ATRIPLA®)

TDF + FTC + RPV (Complera®)

Sofosbuvir (SOF; Sovaldi™)

Other  

Primary Investigator

Name *
Institution *
Complete Address * (street, city, state, zip code)

CountryUnited States
Phone *
Mobile / Pager
Email *
Curriculum vitae * (please attach)


 

Study Population / Demographics

Please Check All That Apply

HIV  Applicable  Not Applicable *
 
HIV+

HIV-

Co-Infected HBV

Co-Infected HCV

Treatment-Naive

Treatment-Experienced

Treatment Failure

Salvage
  Suppressed

Mother to Child Transmission

Pediatric

Elderly

Prevention

Gender

Testing
 
 
 
HBV  Applicable  Not Applicable *
 
Co-infected HIV

Co-infected HCV

Co-Infected HDV

Chronic Carrier

Cirrhotic Compensated

Cirrhotic Decompensated

HCC

HBeAg+

HBeAg-

Pre Liver Transplant

Post Liver Transplant
  Normal ALT

IFN Non Responder

LAM Resistant

Entecavir Resistant

Adefovir Resistant

NUC Non Responder

Treatment-Naive

Treatment-Experienced

Treatment Failure

Pediatric

Elderly
 
 
 
PAH  Applicable  Not Applicable *
 
 
WHO Classification:
 
Group I. Pulmonary Arterial Hypertension
 
Group II. Pulmonary Venous Hypertension
 
Group IIII. Pulmonary Hypertension Associated with Hypoxemia
 
Group IV. Pulmonary Hypertension due to Chronic Thrombotic Disease, Embolic disease or Both
 
Group V. Miscellaneous
Treatment-Naive

Treatment-Experienced

Add-on Therapy

Upfront Combination Therapy

Pediatric

Geriatric
 
 
 
SIHD (Stable Ischemic Heart Disease)  Applicable  Not Applicable *
 


Chronic stable angina/SIHD



Angina equivalents



Angina sub-populations (Women, Ethnicity, Geriatric, etc.)



Diabetes Mellitus



Non-obstructive CAD/Microvascular disease



Incomplete Revascularization



Health Economics/Outcomes



Other

 
 
 
CF (Cystic Fibrosis)  Applicable  Not Applicable *
 
P. aeruginosa

Infection other
than P. aeruginosa


Assessment and Outcomes
  Adults

Pediatrics
 
 
 
 
HCV  Applicable  Not Applicable *
 
Additional Information *
 
Oncology  Applicable  Not Applicable *
 
Additional Information *
 
Other  Applicable  Not Applicable *
 
Additional Information *
 

Study Proposal

Please Check All That Apply

Program Type *Interventional

Non-Interventional

 Clinical Trial

Prospective Cohort

In Vitro Research

Registry
Prospective Cohort

Retrospective Cohort

In Vitro Research

Registry

Please Check All That Apply

Scope of Trial *Safety

Efficacy

Tolerability

Diagnosis

Dose Response

Bioequivalence

Therapy

Prophylaxis
Comparative Effectiveness Research

Screening

Epidemiology

Pharmacodynamic

Pharmacokinetics

Pharmacogenetic/genomic

Pharmacoeconomics

Please Check All That Apply

Clinical Design *Single Arm

Multi-arm

Blinded

Open-label

Pilot Study

Randomized

Non-randomized

Placebo-controlled

Combination Therapy

Drug-drug Interaction

Mechanism of Action
Switch

Intensification

Adherence

Quality of Life

Resistance

Virology

Immunology

PrEP Demonstration Project

Prevention of Mother to Child Transmission

Pediatric

Seroconversion

Study Details

As you enter data, please monitor the number of maximum characters for the following fields. If the data that you have exceeds the maximum amount of characters, you can attach a separate document that contains this information.

Scientific Rationale *
0 of 1500 maximum characters
Objectives *Primary Objective:
0 of 800 maximum characters
Secondary Objective(s):
0 of 800 maximum characters
Endpoints *Primary Endpoint:
0 of 800 maximum characters
Secondary Endpoints(s):
0 of 800 maximum characters
Study Details Document (please attach)

Projected Study Design *

Projected Number of Subjects *
Projected Number
of Sites *
(if additional sites, please specify)

Additional Info:
Participating Countries *
(CTRL-Click to select multiple countries)
Estimated First Patient First Visit Date *
Estimated Last Patient Last Visit Date *
Projected Duration of Enrollment * 
Projected Duration of Treatment * 
Eligibility Criteria * (Inclusion/Exclusion)

Study Duration *
Regimens * (Include dose and mode of administration)

Product:
Dose:
Frequency:
Study Procedure / Frequency Table(if applicable, attach additional details)
Other Evaluations (e.g. Pharmacokinetics)

Statistical Methods *
References
Conference / Publication Plans *
Conference / Year


Journal / Year
Additional Comments
Upload Additional Supporting Documents *



Type of Support Requested

Budget * (Attach or fax budget spreadsheet)




Study Drug (If applicable, specify drug, strength, and total quantity needed to complete study)




Gilead Contact

Have you discussed this study proposal with a Gilead Medical Scientist and/or a Gilead Medical Affairs Director or Clinical Research Director? *



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