Contact Information

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Study Title *

Date 01/06/2009

Study Product *

Tenofovir DF (TDF; Viread®), HIV Tenofovir DF (TDF; Viread®), HBV Emtricitabine (FTC; Emtriva®) TDF + FTC (Truvada®) TDF + FTC + EFV (Atripla®) Adefovir (Hepsera®) Ambrisentan (Letairis®)

Primary Investigator

Name *     Institution *     Complete Address * (street, city, state, zip code)     Country * United StatesAfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBosnia and HerzegowinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCook IslandsCosta RicaCote D'IvoireCroatiaCubaCyprusCzech RepublicDenmarkDjiboutiDominicaDominican RepublicEast TimorEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland Islands (Malvinas)Faroe IslandsFijiFinlandFranceFrance, MetropolitanFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuineaGuinea-bissauGuyanaHaitiHeard and Mc Donald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIran (Islamic Republic of)IraqIrelandIsraelItalyJamaicaJapanJordanKazakhstanKenyaKiribatiKorea, Democratic People's Republic ofKorea, Republic ofKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyan Arab JamahiriyaLiechtensteinLithuaniaLuxembourgMacauMacedonia, The Former Yugoslav Republic ofMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesia, Federated States ofMoldova, Republic ofMonacoMongoliaMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNetherlands AntillesNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorthern Mariana IslandsNorwayOmanPakistanPalauPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarReunionRomaniaRussian FederationRwandaSaint Kitts and NevisSaint LuciaSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSeychellesSierra LeoneSingaporeSlovakia (Slovak Republic)SloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSpainSri LankaSt. HelenaSt. Pierre and MiquelonSudanSurinameSvalbard and Jan Mayen IslandsSwazilandSwedenSwitzerlandSyrian Arab RepublicTaiwanTajikistanTanzania, United Republic ofThailandTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited KingdomUnited States Minor Outlying IslandsUruguayUzbekistanVanuatuVatican City State (Holy See)VenezuelaViet NamVirgin Islands (British)Virgin Islands (U.S.)Wallis and Futuna IslandsWestern SaharaYemenYugoslaviaZaireZambiaZimbabwe     Phone *     Mobile / Pager     Email *     Curriculum vitae * (please attach)   Fax Please fax your supporting documentation to (650) 522-4813

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 MTCT Pediatric Elderly       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 (idiopathic, familial, associated with significant venous or capillary involvement, persistent pulmonary hypertension of the newborn)   Group II. Pulmonary Venous Hypertension   Group IIII. Pulmonary Hypertension Associated with Hypoxemia (eg: COPD, interstitial lung disease)   Group IV. Pulmonary Hypertension due to Chronic Thrombotic Disease, Embolic disease or Both (pulmonary embolism, TE obstruction proximal, TE obstruction distal)   Group V. Miscellaneous (eg: sarcoidosis, lymphangiomatosis, pulmonary Langerhans'-cell histiocytosis, and compression of pulmonary vessels) Treatment-Naive Treatment-Experienced Add-on Therapy Upfront Combination Therapy Pediatric Geriatric Renal Impairment Hepatic Impairment Transplant PortoPulmonary Hypertension

Study Proposal

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Program Type * Interventional Non-Interventional   Clinical Trial (International) Clinical Trial (U.S., Canada) 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 Screening Epidemiology Pharmacodynamic Pharmacokinetics Pharmacogenetic/genomic Pharmacoeconomic

Please Check All That Apply

Study 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 and/or Quality of Life Resistance Virology Immunology Metabolic Disorder

Study Details

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     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) United StatesAfghanistanAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBosnia and HerzegowinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBrunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCook IslandsCosta RicaCote D'IvoireCroatiaCubaCyprusCzech RepublicDenmarkDjiboutiDominicaDominican RepublicEast TimorEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland Islands (Malvinas)Faroe IslandsFijiFinlandFranceFrance, MetropolitanFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuineaGuinea-bissauGuyanaHaitiHeard and Mc Donald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIran (Islamic Republic of)IraqIrelandIsraelItalyJamaicaJapanJordanKazakhstanKenyaKiribatiKorea, Democratic People's Republic ofKorea, Republic ofKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyan Arab JamahiriyaLiechtensteinLithuaniaLuxembourgMacauMacedonia, The Former Yugoslav Republic ofMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMicronesia, Federated States ofMoldova, Republic ofMonacoMongoliaMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNetherlands AntillesNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorthern Mariana IslandsNorwayOmanPakistanPalauPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarReunionRomaniaRussian FederationRwandaSaint Kitts and NevisSaint LuciaSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSeychellesSierra LeoneSingaporeSlovakia (Slovak Republic)SloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSpainSri LankaSt. HelenaSt. Pierre and MiquelonSudanSurinameSvalbard and Jan Mayen IslandsSwazilandSwedenSwitzerlandSyrian Arab RepublicTaiwanTajikistanTanzania, United Republic ofThailandTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluUgandaUkraineUnited Arab EmiratesUnited KingdomUnited States Minor Outlying IslandsUruguayUzbekistanVanuatuVatican City State (Holy See)VenezuelaViet NamVirgin Islands (British)Virgin Islands (U.S.)Wallis and Futuna IslandsWestern SaharaYemenYugoslaviaZaireZambiaZimbabwe     Anticipated First Patient In * MonthJanuaryFebruaryMarchAprilMayJuneJulyAugustSeptemberOctoberNovemberDecember Day12345678910111213141516171819202122232425262728293031 Year20052006200720082009201020112012201320142015     Anticipated Last Patient Out * MonthJanuaryFebruaryMarchAprilMayJuneJulyAugustSeptemberOctoberNovemberDecember Day12345678910111213141516171819202122232425262728293031 Year20052006200720082009201020112012201320142015     Projected Duration of Enrollment *   DaysWeeksMonthsYears     Projected Duration of Treatment *   DaysWeeksYears     Eligibility Criteria * (Inclusion/Exclusion)     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 *   Fax Please fax your supporting documentation to (650) 522-4813   None

Type of Support Requested

Budget * (Attach or fax budget spreadsheet)   Fax Please fax your supporting documentation to (650) 522-4813   Not Applicable     Study Drug (If applicable, specify quantity)

Gilead Contact

Have you discussed this study proposal with a Gilead Medical Scientist and/or a Gilead Medical Affairs Director or Clinical Research Director? * Yes   No   Contact Name:

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