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Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.

Study acronym: APR
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Eligibility criteria shortened, about 1 word

    Study description revised; Collaborators: 25 to 27; Study title revised

    Show what changed: Eligibility criteria
    Eligibility Ages Eligible for Study: WomenPeople of childbearing agepotential Inclusion Criteria: Country of origin of report Documentati [...] ntact information (name, address, etc.) Exclusion Criteria: Females• People who were not exposed to registry medications during pregnancy Male patients
    Show what changed: Study description
    [...] any major teratogenic effect when administered to pregnant womenpeople: abacavir (ZIAGEN®, ABC), abacavir/lamivudine (EPZICOM®, KI [...]
    Show what changed: Collaborators
    Alvogen KoreaInc. Strides ShasunPharma Science Limited Yung Shin Pharm. Ind. Co., Ltd. Zydus Pharmaceuticals USA, Inc.
    Show what changed: Study title
    [...] ing Any of the Registry Drugs When Administered to Pregnant WomenPeople.

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Eligibilityv28

  2. Minor

    Collaborators revised (25)

    Show what changed: Collaborators
    CelltrionDr. Reddy's Laboratories Limited

    Study Status, Sponsor/Collaboratorsv27

  3. Minor

    Collaborators: 24 to 25

    Show what changed: Collaborators
    i3 Pharmaceuticals, LLC

    Study Status, Sponsor/Collaboratorsv26

  4. Minor

    Study description expanded, about 3 words

    Collaborators: 28 to 24

    Show what changed: Study description
    [...] (CIMDUO™, 3TC/TDF), lamivudine/zidovudine (COMBIVIR®, CBV), lenacapavir (SUNLENCA, LEN) lopinavir/ritonavir (KALETRA®, ALUVIA®, LPV/r), maraviroc (S [...]
    Show what changed: Collaborators
    Accord Healthcare, Inc. Aurobindo Pharma Ltd Prinston Pharmaceutical Inc. Sandoz Canada Inc.

    Study Status, Sponsor/Collaborators, Study Descriptionv25

  5. Minor

    Collaborators reordered

    Study Status, Sponsor/Collaboratorsv24

Show 22 earlier versions

  1. Minor

    Study description expanded, about 1 word

    Collaborators: 26 to 28

    Show what changed: Study description
    [...] mide (BIKTARVY®, B/F/TAF), cabotegravir (VOCABRIA®, CABENUVA®, APRETUDE®, CAB), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, D [...] ® ATR), efavirenz/lamivudine/tenofovir disoproxil fumarate (SYMFI™/SYMFI LO™, EFV/3TC/TDF), elvitegravir (VITEKTA®, EVG), elvit [...]
    Show what changed: Collaborators
    Pharmascience Inc. Sandoz Canada Inc. Laurus Labs Limited

    Study Status, Sponsor/Collaborators, Study Descriptionv23

  2. Minor

    Study description shortened, about 59 words

    Show what changed: Study description
    [...] regnant women: abacavir (ZIAGEN®, ABC), abacavir/lamivudine combination (EPZICOM®, KIVEXA®, EPZ), abacavir/lamivudine/zidovudine combination (TRIZIVIR®, TZV), abacavir/dolutegravir/lamivudine combination (TRIUMEQ®, TRI), adefovir dipivoxil (HEPSERA®, ADV), ampren [...] E®, APV), atazanavir (REYATAZ®, ATV), atazanavir/cobicistat combination (EVOTAZ®, EVO), bictegravir/emtriciabineemtricitabine/tenofovir alafenamide (BIKTARVY®, B/F/TAF), cabotegravir (VOCABRIA®, CABENUVA®, CAB), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat combination (PREZCOBIX™, REZOLSTA™, PCX), daruna [...] [...]

    Study Status, Study Description, Contacts/Locationsv22

  3. Notable

    Enrollment target: 1600 to 24258

    Collaborators: 28 to 26

    Show what changed: Collaborators
    Hoffmann-La Roche Hetero Labs Ltd. Novartis Pharmaceuticals Strides Shasun Ltd.Limited

    Study Status, Sponsor/Collaborators, Study Design, Eligibilityv21

  4. Minor

    Study description expanded, about 5 words

    Collaborators: 29 to 28

    Show what changed: Study description
    [...] azanavir/cobicistat combination (EVOTAZ®, EVO), bictegravir/emtricitabineemtriciabine/tenofovir alafenamide combination (BIKTARVY®, B/F/TAF), cobicistat (TYBOST®, COBI), darunavir [...] VIDEX® EC, ddI), dolutegravir (TIVICAY®, DTG), dolutegravir+lamivudine+tenofovir disoproxil fumarate (acriptega/teladomyl/tendola, TLD), dolutegravir/rilpivirine combination (JULUCA™, DTG/RPV), doravirine (pifeltro™, PIF), doravirine+lamivudine+tenofovir disoproxil fumarate (delstrigo™, DEL), emtricitabine/ tenofovir alafenamide combination (DESCOVY®,DVY) efavirenz (SUSTIVA®, STOCRIN®, EFV), efavire [...] LA® ATR), efaviren [...]
    Show what changed: Collaborators
    Zentiva Group Laurus LabsCelltrion

    Study Status, Sponsor/Collaborators, Study Description, Contacts/Locationsv20

  5. Minor

    Study description expanded, about 27 words

    Site details revised; Collaborators revised (29)

    Show what changed: Study description
    The following antiretroviral drugs are followed by the Antiretroviral Pregnancy Registry (APR:, Registry) to detect any major teratogenic effect when admin [...] vir (ZIAGEN®, ABC), abacavir/lamivudine combination (EPZICOM®, KIVEXA®, EPZ), abacavir/lamivudine/zidovudine combination (TRIZIVI [...] Z®, ATV), atazanavir/cobicistat combination (EVOTAZ®, EVO), bictegravir/emtricitabine/tenofovir alafenamide combination (BIKTARVY®, B/F/TAF), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, DRV), daru [...] ine (VIDEX®, VIDEX® EC, ddI), dolutegravir (TIVICAY®, DTG), dolutegravir/rilpivirine combination (JULUCA™, DTG/RPV [...] [...]
    Show what changed: Collaborators
    Janssen Scientific Affairs Pfizer Ranbaxy Inc., aLLC Lannett SunPharma Co. Sciegen PharmaceuticalsCompany, Inc. SilarxHikma Pharmaceuticals LLC Accord Healthcare, Inc. West-WardMacleods Pharmaceuticals Ltd Laurus Labs Qilu Pharmaceutical Dr Co., Reddy's Laboratories LimitedLtd.

    Study Status, Sponsor/Collaborators, Study Description, Contacts/Locationsv19

  6. Minor

    Study description expanded, about 42 words

    Collaborators: 28 to 29

    Show what changed: Study description
    [...] regnant women: abacavir (ZIAGEN®, ABC), abacavir/lamivudine combination (EPZICOM®, EPZ), abacavir/lamivudine/zidovudine combination (TRIZIVIR®, TZV), abacavir/dolutegravir/lamivudine combination (TRIUMEQ®, TRI), adefovir dipivoxil (HEPSERA®, ADV), amprenavir (AGENERASE®, APV), atazanavir (REYATAZ®, ATV), atazanavir/cobicistat combination (EVOTAZ®, EVO), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat combination (PREZCOBIX™, REZOLSTA™, PCX), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, ddI), dolutegravir (TIVICAY®, DTG), emtricitabine/ te [...] [...]
    Show what changed: Collaborators
    Janssen R&DScientific IrelandAffairs Ranbaxy Inc., a SunPharma Co. Strides ArcolabShasun Ltd. West-Ward PharmaceuticalsPharmaceutical Zentiva CorporationGroup

    Study Status, Sponsor/Collaborators, Study Descriptionv18

  7. Minor

    Collaborators revised (28)

    Show what changed: Collaborators
    SunshineDr. LakeReddy's PharmaLaboratories Co., Ltd.Limited

    Study Status, Sponsor/Collaboratorsv17

  8. Minor

    Collaborators: 26 to 28

    Show what changed: Collaborators
    Amneal Pharmaceuticals, LLC West-Ward Pharmaceuticals Corporation

    Study Status, Sponsor/Collaboratorsv16

  9. Minor

    Study description shortened, about 22 words

    Collaborators: 25 to 26

    Show what changed: Study description
    [...] /lamivudine (EPZICOM®, EPZ), abacavir/lamivudine/zidovudine combination (TRIZIVIR®, TZV), abacavir/dolutegravir/lamivudine combination (TRIUMEQ®, TRI), adefovir dipivoxil (HEPSERA®, ADV)*, amprenavir (AGENERASE®, APV), atazanavir sulfate (REYATAZ®, ATV), atazanavir/cobicistat combination (EVOTAZ®, EVO), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat combination (PREZCOBIX™, PCX), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, DDIddI), dolutegravir (TIVICAY®, DTG), efavirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitabine/ tenofovir diso [...] [...]
    Show what changed: Collaborators
    Hetero Labs Ltd. Novartis Pharmaceuticals Prinston Pharmaceutical Inc. Alvogen Korea

    Study Status, Sponsor/Collaborators, Study Descriptionv15

  10. Minor

    Enrollment target: 1600

    Primary completion date: Jan 2099; Completion date: Jan 2015 to Jan 2099; Study description expanded, about 20 words; and 1 more

    Show all 5 changes in this update
    • Minor Enrollment target: 1600
    • Minor Primary completion date: Jan 2099
    • Minor Completion date: Jan 2015 to Jan 2099
    • Minor Study description expanded, about 20 words
      Show what changed
      [...] bacavir/lamivudine/zidovudine combination (TRIZIVIR®, TZV), abacavir/dolutegravir/lamivudine combination (TRIUMEQ®, TRI), adefovir dipivoxil (HEPSERA®, ADV)*, amprenavir (AGENERASE®, APV), atazanavir sulfate (REYATAZ®, ATV), atazanavir/cobicistat combination (EVOTAZ®, EVO), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat combination (PREZCOBIX™, PCX), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, ddIDDI), dolutegravir (TIVICAY®, DTG), efavirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitab [...] isoproxil fumarate combination (ATRIPLA, ATR®), e [...]
    • Minor Collaborators: 23 to 25
      Show what changed
      HECHoffmann-La PharmRoche Hetero Lupin USAPharmaceuticals, Inc. IPCAPrinston Sandoz Silarx LaboratoriesPharmaceuticals Inc Sunshine Lake Pharma Co., Ltd. Prinston Pharma Roche Pharma AG ViiV Healthcare (represented by GlaxoSmithKline)

    Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Contacts/Locationsv14

  11. Minor

    Study description expanded, about 2 words

    Collaborators: 22 to 23

    Show what changed: Study description
    [...] ylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, ddI), dolutegravir (TIVICAY®), efavirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitab [...]
    Show what changed: Collaborators
    AbbottAbbVie Prinston Pharma Sigmapharm Laboratories

    Study Status, Sponsor/Collaborators, Study Description, Contacts/Locationsv13

  12. Minor

    2 amendments

    2 re-verifications since 2013-02-27, no change to tracked fields

    v11-v12

  13. Minor

    Study description expanded, about 19 words

    Collaborators: 16 to 22

    Show what changed: Study description
    [...] ination (TRIZIVIR®, TZV), adefovir dipivoxil (HEPSERA®, ADV)*, amprenavir (AGENERASE®, APV), atazanavir sulfate (REYATAZ® [...] SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitabine/tenofovir DFdisoproxil fumarate combination (ATRIPLA®, ATR®), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STRIBILD™, STB), emtricitabine (EMTRIVA®, FTC), enfuvirtide (FUZEON®, T-20), entecavir (BARACLUDE®, ETV)*, etravirine (INTELENCE®, ETR), fosamprenavir calcium (LEXIV [...] AN®, IDV), lamivudine (EPIVIR®, 3TC), lamivudine/zidovudine combination (COMBIVIR®, ZDV+3TC), lopinavir/ritonavir combination (KALETR [...] [...]
    Show what changed: Collaborators
    TibotecApotex PharmaceuticalInc. HEC LimitedPharm IPCA Laboratories Ltd. Janssen R&D Ireland Prinston Sciegen Pharmaceuticals Inc. Strides Arcolab Ltd.

    Study Status, Sponsor/Collaborators, Study Description, Contacts/Locationsv10

  14. Minor

    Study description shortened, about 17 words

    Show what changed: Study description
    [...] when administered to pregnant women: abacavir (ZIAGEN®, ABC);, abacavir+/lamivudine (EPZICOM®, EPZ);, abacavir+/lamivudine+/zidovudine combination (TRIZIVIR®, TZV);, adefovir dipivoxil (HEPSERA®, ADV);, amprenavir (AGENERASE®, APV)(APV no longer manufactured as of 2007);, atazanavir sulfate (REYATAZ®, ATV);, darunavir (PREZISTA™®, DRV);, delavirdine mesylate (RESCRIPTOR®, DLV);, didanosine (VIDEX®, VIDEX® EC, ddI);, efavirenz (SUSTIVA®, STOCRIN®, EFV);, efavirenz+/emtricitabine+/ tenofovir disoproxil fumarate combinationDF (ATRIPLA®, ATR);, emtricitabine (EMTRIVA®, FTC);, enfuvirtide (FUZEON®, [...] [...]

    Study Status, Sponsor/Collaborators, Study Description, Contacts/Locationsv9

  15. Minor

    Study title expanded, about 4 words

    Show what changed: Study title
    Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effec [...]

    Study Identification, Study Statusv8

  16. Minor

    Completion date: Jun 2010 to Jan 2015

    Study description expanded, about 16 words; Collaborators revised (16)

    Show what changed: Study description
    The following antiretroviral drugs are followed by the Antiretroviral Pregnancy Registry (APR: Registry) to detect any major teratogenic effect when administered to pregnant women: abacavir (ZIAGEN®, ABC),; abacavir/+lamivudine (EPZICOM®),; abacavir/+lamivudine/+zidovudine combination (TRIZIVIR®, TZV),; adefovir dipivoxil (HEPSERA®, ADV)*,; amprenavir (AGENERASE®, APV),(APV no longer manufactured as of 2007); atazanavir sulfate (REYATAZ®, ATV),; darunavir (PREZISTA™, DRV),; delavirdine mesylate (RESCRIPTOR®, DLV),; didanosine (VIDEX®, VIDEX® EC, ddI),; efavirenz (SUSTIVA®, STOCRIN®, EFV),; efa [...] [...]
    Show what changed: Collaborators
    BarrTeva LaboratoriesPharmaceuticals USA ViiV Healthcare (represented by GlaxoSmithKline)

    Study Status, Sponsor/Collaborators, Study Description, Referencesv7

  17. Minor

    Collaborators revised (16)

    Show what changed: Collaborators
    Hoffmann-LaRoche RochePharma AG

    Study Status, Sponsor/Collaborators, Contacts/Locationsv6

  18. Minor

    Collaborators: 15 to 16

    Show what changed: Collaborators
    Hetero USA

    Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locationsv5

  19. Minor

    Completion date: Jun 2007 to Jun 2010

    Study description expanded, about 13 words; Collaborators: 12 to 15

    Show what changed: Study description
    [...] women: abacavir (ZIAGEN®, ABC), abacavir/lamivudine (EPZICOM™®), abacavir/lamivudine/zidovudine combination (TRIZIVIR®, TZ [...] , atazanavir sulfate (REYATAZ®, ATV), darunavir (PREZISTA™, TMC114DRV), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDE [...] icitabine/tenofovir disoproxil fumarate combination (ATRIPLA, ATR™), emtricitabine (EMTRIVA®, FTC), enfuvirtide (FUZEON®, T-20), entecavir (BARACLUDE®, ETV)*, etravirine (INTELENCE™, ETR), fosamprenavir calcium (LEXIVA®, FOS), indinavir (CRIXIVAN® [...] lopinavir/ritonavir combination (KALETRA®, ALUVIA®, LPV/r), maraviroc (SELZENTRY™, CENSENTRI™, MVC), n [...] [...]
    Show what changed: Collaborators
    Aurobindo Pharma Ltd Cipla Ltd. Mylan Laboratories

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Eligibilityv4

  20. Minor

    Study description revised

    Collaborators revised (12)

    Show what changed: Study description
    [...] favirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitabine/tenovofirtenofovir disoproxil fumarate combination (ATRIPLA™), emtricitabine ( [...]
    Show what changed: Collaborators
    Ranbaxy Laboratories LimitedInc.

    Study Status, Sponsor/Collaborators, Study Description, Study Designv3

  21. Minor

    Completion date: Jan 2006 to Jun 2007

    Study description expanded, about 8 words; Collaborators: 9 to 12

    Show what changed: Study description
    [...] avir (AGENERASE®, APV), atazanavir sulfate (REYATAZ®, ATV), darunavir (PREZISTA™, TMC114), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, [...] VA®, FTC), enfuvirtide (FUZEON®, T-20), entecavir (BARACLUDE™®, ETV)*, fosamprenavir calcium (LEXIVA®, FOS), indinavir (CR [...] OMBIVIR®, ZDV+3TC), lopinavir/ritonavir combination (KALETRA®, ALUVIA®, LPV/r), nelfinavir (VIRACEPT®, NFV), nevirapine (VIRAMUNE [...] vir mesylate (INVIRASE®, SQV-HGC), stavudine (ZERIT®, d4T), telbivudine (SEBIVO®, TYZEKA™, LdT)*, tenofovir disoproxil fumarate (VIREAD®, TDF), tenofovir diso [...]
    Show what changed: Collaborators
    Novartis Ranbaxy Laboratories Limited Tibotec Pharmaceutical Limited

    Study Status, Sponsor/Collaborators, Oversight, Study Descriptionv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Syneos Health
2 trials monitored
See 1 trial at risk
The purpose of the Antiretroviral Pregnancy Registry (Registry) is to detect any major teratogenic effect involving any of the Registry drugs when administered to pregnant people. Registration is voluntary and confidential with information obtained from the health care provider. A Registry-assigned identifier allows for follow-up capability. Information on subjects is provided to the Registry prospectively (prior to the outcome of pregnancy being known) through their health care provider, with follow-up obtained from the health care provider after the outcome is determined. Providers are strongly urged to enroll their patients as early in pregnancy as possible to maximize the validity of the data. In addition, the Registry is very interested in assembling a group of providers who are willing to make a commitment to report all of their site's antiretroviral pregnancy exposures to the Registry, thereby assuring all cases can be considered prospective. Providers are encouraged to contact the Registry for more information about this group. The Registry is informed in its analysis by other data, for example, retrospective reports and clinical studies. Given the increasing number of medications and more aggressive approach to therapy, more HIV- and hepatitis B-infected people may be treated during pregnancy or become pregnant while under treatment. The paucity of data on use and infant outcomes of antiretroviral therapies during pregnancy makes this Registry an essential component of the ongoing program of epidemiologic studies of the safety of these therapies. Each year the Registry has enrolled approximately 1300-1700 pregnant people in the US exposed to antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive people who give birth to live infants annually in the US.
Trial Details
NCT Number NCT00404989
Lead Sponsor Syneos Health
Collaborators: AbbVie, Alvogen Inc., Amneal Pharmaceuticals, LLC, Apotex Inc., Boehringer Ingelheim, Bristol-Myers Squibb, Cipla Ltd., Dr. Reddy's Laboratories Limited, Gilead Sciences, Hetero Labs, Hikma Pharmaceuticals LLC, i3 Pharmaceuticals, LLC, Janssen Scientific Affairs, LLC, Lannett Company, Inc., Laurus Labs Limited, Lupin Pharmaceuticals, Inc., Macleods Pharmaceuticals Ltd, Merck Sharp & Dohme LLC, Mylan Laboratories, Pharmascience Inc., Qilu Pharmaceutical Co., Ltd., Sigmapharm Laboratories, Strides Pharma Science Limited, Teva Pharmaceuticals USA, ViiV Healthcare, Yung Shin Pharm. Ind. Co., Ltd., Zydus Pharmaceuticals USA, Inc.
Conditions HIV Infections, Hepatitis B
Enrollment 24,258 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov