Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant Women.
| Status: | Recruiting |
|---|---|
| Conditions: | HIV / AIDS, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 12 - 60 |
| Updated: | 4/6/2019 |
| Start Date: | January 1989 |
| End Date: | January 2099 |
| Contact: | Taylor Cook |
| Email: | SM_APR@syneoshealth.com |
| Phone: | 800-258-4263 |
Antiretroviral Pregnancy Registry
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 women.
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 women 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 women in the US exposed
to antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive
women who give birth to live infants annually in the US.
teratogenic effect involving any of the Registry drugs when administered to pregnant women.
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 women 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 women in the US exposed
to antiretroviral drugs. This number represents approximately 15% of the 8,700 HIV positive
women who give birth to live infants annually in the US.
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 combination (EPZICOM®, KIVEXA®, 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),
bictegravir/emtriciabine/tenofovir alafenamide (BIKTARVY®, B/F/TAF), cobicistat (TYBOST®,
COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat combination (PREZCOBIX™, REZOLSTA™,
PCX), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, ddI),
dolutegravir (TIVICAY®, DTG), dolutegravir+lamivudine+tenofovir disoproxil fumarate
(acriptega/teladomyl/tendola, TLD), dolutegravir/rilpivirine (JULUCA™, DTG/RPV), doravirine
(pifeltro™, PIF), doravirine+lamivudine+tenofovir disoproxil fumarate (delstrigo™, DEL),
emtricitabine/ tenofovir alafenamide (DESCOVY®,DVY) efavirenz (SUSTIVA®, STOCRIN®, EFV),
efavirenz/emtricitabine/ tenofovir disoproxil combination (ATRIPLA® ATR),
efavirenz/lamivudine/tenofovir disoproxil fumarate (SYMFI LO™, EFV/3TC/TDF), elvitegravir
(VITEKTA®, EVG), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide combination
(GENVOYA®, GEN), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
combination (STRIBILD®, STB), emtricitabine (EMTRIVA®, FTC), enfuvirtide (FUZEON®, T-20),
entecavir (BARACLUDE®, ETV), etravirine (INTELENCE®, ETR), fosamprenavir calcium (LEXIVA®,
FOS), indinavir (CRIXIVAN®, IDV), lamivudine (EPIVIR®, 3TC), lamivudine/raltegravir
combination (DUTREBIS™, DUT), lamivudine/tenofovir disoproxil fumarate (CIMDUO™, 3TC/TDF),
lamivudine/zidovudine combination (COMBIVIR®, CBV), lopinavir/ritonavir combination
(KALETRA®, ALUVIA®, LPV/r), maraviroc (SELZENTRY®, CELSENTRI®, MVC), nelfinavir (VIRACEPT®,
NFV), nevirapine (VIRAMUNE®, VIRAMUNE® XR™, NVP), raltegravir (ISENTRESS®, RAL), rilpivirine
(EDURANT®, RPV), rilpivirine/emtricitabine/tenofovir alafenamide (ODEFSEY®,ODE)
rilpivirine/emtricitabine/tenofovir disoproxil combination (COMPLERA®, CPA; EVIPLERA®, EPA),
ritonavir (NORVIR®, RTV), saquinavir (FORTOVASE®, SQV-SGC), saquinavir mesylate (INVIRASE®,
SQV-HGC), stavudine (ZERIT®, d4T), telbivudine (SEBIVO®, TYZEKA®, LdT), tenofovir alafenamide
(VEMLIDY®, TAF), tenofovir disoproxil fumarate (VIREAD®, TDF), tenofovir disoproxil fumarate
/emtricitabine (TRUVADA®, TVD), tipranavir (APTIVUS®, TPV), zalcitabine (HIVID®, ddC), and
zidovudine (RETROVIR®, ZDV).
Zidovudine is indicated for use in the second and third trimesters of pregnancy to reduce the
risk of maternal-fetal HIV transmission. There are also several other completed and ongoing
studies in maternal-fetal transmission with other therapies. However, the safety of prenatal
zidovudine or any other antiretroviral therapy exposure to the fetus has not been
established.
(APR, Registry) to detect any major teratogenic effect when administered to pregnant 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), amprenavir (AGENERASE®,
APV), atazanavir (REYATAZ®, ATV), atazanavir/cobicistat combination (EVOTAZ®, EVO),
bictegravir/emtriciabine/tenofovir alafenamide (BIKTARVY®, B/F/TAF), cobicistat (TYBOST®,
COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat combination (PREZCOBIX™, REZOLSTA™,
PCX), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, ddI),
dolutegravir (TIVICAY®, DTG), dolutegravir+lamivudine+tenofovir disoproxil fumarate
(acriptega/teladomyl/tendola, TLD), dolutegravir/rilpivirine (JULUCA™, DTG/RPV), doravirine
(pifeltro™, PIF), doravirine+lamivudine+tenofovir disoproxil fumarate (delstrigo™, DEL),
emtricitabine/ tenofovir alafenamide (DESCOVY®,DVY) efavirenz (SUSTIVA®, STOCRIN®, EFV),
efavirenz/emtricitabine/ tenofovir disoproxil combination (ATRIPLA® ATR),
efavirenz/lamivudine/tenofovir disoproxil fumarate (SYMFI LO™, EFV/3TC/TDF), elvitegravir
(VITEKTA®, EVG), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide combination
(GENVOYA®, GEN), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
combination (STRIBILD®, STB), emtricitabine (EMTRIVA®, FTC), enfuvirtide (FUZEON®, T-20),
entecavir (BARACLUDE®, ETV), etravirine (INTELENCE®, ETR), fosamprenavir calcium (LEXIVA®,
FOS), indinavir (CRIXIVAN®, IDV), lamivudine (EPIVIR®, 3TC), lamivudine/raltegravir
combination (DUTREBIS™, DUT), lamivudine/tenofovir disoproxil fumarate (CIMDUO™, 3TC/TDF),
lamivudine/zidovudine combination (COMBIVIR®, CBV), lopinavir/ritonavir combination
(KALETRA®, ALUVIA®, LPV/r), maraviroc (SELZENTRY®, CELSENTRI®, MVC), nelfinavir (VIRACEPT®,
NFV), nevirapine (VIRAMUNE®, VIRAMUNE® XR™, NVP), raltegravir (ISENTRESS®, RAL), rilpivirine
(EDURANT®, RPV), rilpivirine/emtricitabine/tenofovir alafenamide (ODEFSEY®,ODE)
rilpivirine/emtricitabine/tenofovir disoproxil combination (COMPLERA®, CPA; EVIPLERA®, EPA),
ritonavir (NORVIR®, RTV), saquinavir (FORTOVASE®, SQV-SGC), saquinavir mesylate (INVIRASE®,
SQV-HGC), stavudine (ZERIT®, d4T), telbivudine (SEBIVO®, TYZEKA®, LdT), tenofovir alafenamide
(VEMLIDY®, TAF), tenofovir disoproxil fumarate (VIREAD®, TDF), tenofovir disoproxil fumarate
/emtricitabine (TRUVADA®, TVD), tipranavir (APTIVUS®, TPV), zalcitabine (HIVID®, ddC), and
zidovudine (RETROVIR®, ZDV).
Zidovudine is indicated for use in the second and third trimesters of pregnancy to reduce the
risk of maternal-fetal HIV transmission. There are also several other completed and ongoing
studies in maternal-fetal transmission with other therapies. However, the safety of prenatal
zidovudine or any other antiretroviral therapy exposure to the fetus has not been
established.
Eligibility Ages Eligible for Study: Women of childbearing age
Inclusion Criteria:
- Country of origin of report
- Documentation that the registry drug was taken during pregnancy
- Sufficient information to determine if the pregnancy is being prospectively or
retrospectively registered
- Date the pregnancy was registered
- Source of report (patient or health care provider)
- Whether the pregnancy outcome is already known or delivery is still pending
- Timing of the prenatal exposure to the registry medication (no broader than which
trimester)
- Sufficient patient identifier relevant to reporter to allow for follow-up
- Was patient involved in a study at the time of prenatal exposure
- Full reporter contact information (name, address, etc.)
Exclusion Criteria:
- Females who were not exposed to registry medications during pregnancy
- Male patients
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