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Investigator's Brochure Table

         Recently distributed IBs are highlighted.

Drugs

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1ABT-267, ABT 333, ABT-450 and RitonavirAbbVieJUN 2017  
2Bedaquiline (TMC207)Janssen Research & DevelopmentDEC 2016  
3Dapivirine (Microbicide Gel)International Partnership for Microbicides MAY 2017 True
4Dapivirine (Vaginal Ring) International Partnership For Microbicides JUL 2017 True
5Dapivirine-Levonorgestrel (Vaginal Ring)International Partnership for Microbicides JUN 2016  
6Delamanid (OPC-67683)OtsukaAPR 2017  
7Dolutegravir (GSK1349572)ViiV Healthcare OCT 2016  
8Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) Gilead Sciences DEC 2016YES 
9Etravirine (TMC125, Intelence)Janssen Research & DevelopmentFEB 2016  
10GSK1265744 (Cabotegravir)ViiV Healthcare DEC 2016  
11HEC Placebo GelCONRADSEP 2011  
12Maraviroc (UK-427857) ViiV HealthcareJAN 2016  
13Raltegravir (Isentress)MerckSEP 2016YES 
14RifapentineSanofiAUG 2013  
15Rilpivirine (TMC278, Edurant) Janssen Research & DevelopmentNOV 2014  
16Tenofovir Gel CONRADJAN 2013  


Vaccines


1Ad26.ENVA.01Crucell Holland BVJUN 2013  
2Ad5HVR48.ENVA.01Crucell Holland APR 2008  
3AIDSVAX B/E Global Solutions for Infectious DiseasesMAR 2016  
4ALVAC-HIV (vCP2438)Sanofi PasteurAUG 2017 True
5Bivalent Subtype C gp120 with Aluminum Hydroxide Adjuvant NIAID/NIHJUN 2015  
6Bivalent Subtype C gp120/AS01B GlaxoSmithKline JUL 2016  
7Bivalent Subtype C gp120/MF59 GlaxoSmithKlineJUL 2016  
8DNA Mosaic-Tre env DNA VaccineDAIDS/NIAID/NIHJUL 2016  
9DNA-HIV-PT123 IPPOX MAY 2016  
10DNA-HIV-PT123/NYVAC-HIV-PT1/NYVAC-HIV-PT4 vaccine IPPOX/EuroVacc AUG 2013  
11EnvSeq-1 Vaccine (CH505TF gp120)DAIDS/NIAID/NIHAUG 2016  
12GEO-D03 and MVA-HIV62B Vaccines (Preventative)GeoVaxJUN 2013  
13GLA-SEInfectious Disease Research Institute (IDRI)MAY 2017 True
14HIV-1 Multiantigen pDNA Vaccine and Human IL-12 pDNAProfectus BioSciencesFEB 2016  
15MVA-CMDR Walter Reed Army Institute Research (WRAIR)DEC 2016  
16p24CE1/2 multivalent pDNA Vaccine expressing HIV M Group p24 Gag and p55 gag pDNA with IL-12 pDNANCI/NIAID/NIHNOV 2016  
17PENNVAX-GP and IL-12 DNA Inovio Parmaceuticals DEC 2016  
18RSV 276 LID/NIAID/NIHMAY 2017  
19RSV D46/NS2/N/deltaM2-2-HindIIILID/NIAID/NIHDEC 2016  
20RSV DeltaNS2-Delta1313-I1314LLID/NIAID/NIHMAR 2013  
21RSV LID deltaM2-2 1030sLID/NIAID/NIHMAR 2016  
22rVSV HIV Vaccines Profectus BioSciences JAN 2016  
23VRC-HIVADV014-00-VP (Multiclade rAd5 HIV-1 Vaccine) and rAd5 component vaccines VRC/NIAID AUG 2009  
24VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP Combination VRC/NIAID AUG 2012  
25VRC-HIVMAB060-00-AB (VRC01) VRC/NIAID AUG 2017 True
26VRC-HIVMAB075-00-AB (VRC07-523LS) MAR 2016  
27VRC-HIVMAB080-00-AB (VRC01LS) VRC/NIAID AUG 2017 True

ABT-267, ABT 333, ABT-450 and RitonavirDrugAbbVieJUN 2017  
Bedaquiline (TMC207)DrugJanssen Research & DevelopmentDEC 2016  
Dapivirine (Microbicide Gel)DrugInternational Partnership for Microbicides MAY 2017 True
Dapivirine (Vaginal Ring) DrugInternational Partnership For Microbicides JUL 2017 True
Dapivirine-Levonorgestrel (Vaginal Ring)DrugInternational Partnership for Microbicides JUN 2016  
Delamanid (OPC-67683)DrugOtsukaAPR 2017  
Dolutegravir (GSK1349572)DrugViiV Healthcare OCT 2016  
Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) DrugGilead Sciences DEC 2016YES 
Etravirine (TMC125, Intelence)DrugJanssen Research & DevelopmentFEB 2016  
GSK1265744 (Cabotegravir)DrugViiV Healthcare DEC 2016  
HEC Placebo GelDrugCONRADSEP 2011  
Maraviroc (UK-427857) DrugViiV HealthcareJAN 2016  
Raltegravir (Isentress)DrugMerckSEP 2016YES 
RifapentineDrugSanofiAUG 2013  
Rilpivirine (TMC278, Edurant) DrugJanssen Research & DevelopmentNOV 2014  
Tenofovir Gel DrugCONRADJAN 2013  
Ad26.ENVA.01VaccineCrucell Holland BVJUN 2013  
Ad5HVR48.ENVA.01VaccineCrucell Holland APR 2008  
AIDSVAX B/E VaccineGlobal Solutions for Infectious DiseasesMAR 2016  
ALVAC-HIV (vCP2438)VaccineSanofi PasteurAUG 2017 True
Bivalent Subtype C gp120 with Aluminum Hydroxide Adjuvant VaccineNIAID/NIHJUN 2015  
Bivalent Subtype C gp120/AS01B VaccineGlaxoSmithKline JUL 2016  
Bivalent Subtype C gp120/MF59 VaccineGlaxoSmithKlineJUL 2016  
DNA Mosaic-Tre env DNA VaccineVaccineDAIDS/NIAID/NIHJUL 2016  
DNA-HIV-PT123 VaccineIPPOX MAY 2016  
DNA-HIV-PT123/NYVAC-HIV-PT1/NYVAC-HIV-PT4 vaccine VaccineIPPOX/EuroVacc AUG 2013  
EnvSeq-1 Vaccine (CH505TF gp120)VaccineDAIDS/NIAID/NIHAUG 2016  
GEO-D03 and MVA-HIV62B Vaccines (Preventative)VaccineGeoVaxJUN 2013  
GLA-SEVaccineInfectious Disease Research Institute (IDRI)MAY 2017 True
HIV-1 Multiantigen pDNA Vaccine and Human IL-12 pDNAVaccineProfectus BioSciencesFEB 2016  
MVA-CMDR VaccineWalter Reed Army Institute Research (WRAIR)DEC 2016  
p24CE1/2 multivalent pDNA Vaccine expressing HIV M Group p24 Gag and p55 gag pDNA with IL-12 pDNAVaccineNCI/NIAID/NIHNOV 2016  
PENNVAX-GP and IL-12 DNA VaccineInovio Parmaceuticals DEC 2016  
RSV 276 VaccineLID/NIAID/NIHMAY 2017  
RSV D46/NS2/N/deltaM2-2-HindIIIVaccineLID/NIAID/NIHDEC 2016  
RSV DeltaNS2-Delta1313-I1314LVaccineLID/NIAID/NIHMAR 2013  
RSV LID deltaM2-2 1030sVaccineLID/NIAID/NIHMAR 2016  
rVSV HIV Vaccines VaccineProfectus BioSciences JAN 2016  
VRC-HIVADV014-00-VP (Multiclade rAd5 HIV-1 Vaccine) and rAd5 component vaccines VaccineVRC/NIAID AUG 2009  
VRC-HIVADV014-00-VP and VRC-HIVDNA016-00-VP Combination VaccineVRC/NIAID AUG 2012  
VRC-HIVMAB060-00-AB (VRC01) VaccineVRC/NIAID AUG 2017 True
VRC-HIVMAB075-00-AB (VRC07-523LS)Vaccine MAR 2016  
VRC-HIVMAB080-00-AB (VRC01LS) VaccineVRC/NIAID AUG 2017 True
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Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).

HomeWebsite User Feedback | Accessibility | Privacy Policy | Disclaimer
Copyright © DAIDS RSC. All rights reserved.
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201700014C, entitled NIAID DAIDS Regulatory Support Center (RSC).