An observational study in HIV Infections and Hepatitis B, sponsored by Syneos Health. Recruiting at 1 site in United States. Open to female participants aged 12 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Syneos Health · Observational
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.
The following antiretroviral drugs are followed by the Antiretroviral Pregnancy Registry (APR, Registry) to detect any major teratogenic effect when administered to pregnant people: abacavir (ZIAGEN®, ABC), abacavir/lamivudine (EPZICOM®, KIVEXA®, EPZ), abacavir/lamivudine/zidovudine (TRIZIVIR®, TZV), abacavir/dolutegravir/lamivudine (TRIUMEQ®, TRI), adefovir dipivoxil (HEPSERA®, ADV), amprenavir (AGENERASE®, APV), atazanavir (REYATAZ®, ATV), atazanavir/cobicistat (EVOTAZ®, EVO), bictegravir/emtricitabine/tenofovir alafenamide (BIKTARVY®, B/F/TAF), cabotegravir (VOCABRIA®, CABENUVA®, APRETUDE®, CAB), cobicistat (TYBOST®, COBI), darunavir (PREZISTA®, DRV), darunavir/cobicistat (PREZCOBIX™, REZOLSTA™, PCX), darunavir/cobicistat/emtricitabine/tenofovir alafenamide (SYMTUZA®, DCF TAF ), delavirdine mesylate (RESCRIPTOR®, DLV), didanosine (VIDEX®, VIDEX® EC, ddI), dolutegravir (TIVICAY®, DTG), dolutegravir/lamivudine (DOVATO®, DTG/RPV), dolutegravir/lamivudine/tenofovir disoproxil fumarate (ACRIPTEGA/TELADOMYL/TENDOLA, TLD), dolutegravir/rilpivirine (JULUCA™, DTG/RPV), emtricitabine/tenofovir alafenamide (DESCOVY®, DVY), efavirenz (SUSTIVA®, STOCRIN®, EFV), efavirenz/emtricitabine/tenofovir disoproxil (ATRIPLA® ATR), efavirenz/lamivudine/tenofovir disoproxil fumarate (SYMFI™/SYMFI LO™, EFV/3TC/TDF), elvitegravir (VITEKTA®, EVG), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (GENVOYA®, GEN), elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STRIBILD®, STB), emtricitabine (EMTRIVA®, FTC), enfuvirtide (FUZEON®, T-20), entecavir (BARACLUDE®, ETV), etravirine (INTELENCE®, ETR), fosamprenavir calcium (LEXIVA®, FOS), fostemsavir (RUKOBIA, FTR), indinavir (CRIXIVAN®, IDV), lamivudine (EPIVIR®, 3TC), lamivudine/raltegravir (DUTREBIS™, DUT), lamivudine/tenofovir disoproxil fumarate (CIMDUO™, 3TC/TDF), lamivudine/zidovudine (COMBIVIR®, CBV), lenacapavir (SUNLENCA, LEN) lopinavir/ritonavir (KALETRA®, ALUVIA®, LPV/r), maraviroc (SELZENTRY®, CELSENTRI®, MVC), nelfinavir (VIRACEPT®, NFV), nevirapine (VIRAMUNE®, VIRAMUNE® XR™, NVP), raltegravir (ISENTRESS®, RAL), rilpivirine (EDURANT®, REKAMBYS®, CABENUVA®, RPV), rilpivirine/emtricitabine/tenofovir alafenamide (ODEFSEY®,ODE), rilpivirine/emtricitabine/tenofovir disoproxil (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).
4,734 studies on the registry are indexed under HIV Infections; 244 are open to participants now.
This study's planned enrollment of 24,258 is above the median of 200 across 781 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Syneos Health is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant people exposed to antiviral medications during pregnancy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Eligibility Ages Eligible for Study: People of
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The record gives a start of Jan 1989, a primary completion of Jan 2099 and a completion of Jan 2099. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
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