Clinical trial NCT00404989: Antiretroviral Pregnancy Registry (APR): Multi-sponsor Registry to Detect Any Major Teratogenic Effect Involving Any of the Registry Drugs When Administered to Pregnant People.
Official title: Antiretroviral Pregnancy Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
Hepatitis B
Keywords: HIV
HBV
Hepatitis
Pregnancy
Registry
Lead sponsor: Syneos Health
Sponsor class: OTHER
Collaborators: name: AbbVie
name: Alvogen Inc.
name: Amneal Pharmaceuticals, LLC
name: Apotex Corp.
name: Boehringer Ingelheim
name: Bristol-Myers Squibb
name: Cipla Ltd.
name: Dr. Reddy's Laboratories Limited
name: Gilead Sciences
name: Hetero Labs
name: Hikma Pharmaceuticals LLC
name: i3 Pharmaceuticals, LLC
name: Janssen Scientific Affairs, LLC
name: Lannett Company, Inc.
name: Laurus Labs Limited
name: Lupin Pharmaceuticals, Inc.
name: Macleods Pharmaceuticals Ltd
name: Merck Sharp & Dohme LLC
name: Mylan Laboratories
name: Pharmascience Inc.
name: Qilu Pharmaceutical Co., Ltd.
name: Sigmapharm Laboratories
name: Strides Pharma Science Limited
name: Teva Pharmaceuticals USA
name: ViiV Healthcare
name: Yung Shin Pharm. Ind. Co., Ltd.
name: Zydus Pharmaceuticals USA, Inc.
First posted: 2006-11-29
Enrollment: 24258
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant people exposed to antiviral medications during pregnancy.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Eligibility Ages Eligible for Study: People of childbearing potential

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:

• People who were not exposed to registry medications during pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Registry Coordinating Center
state: North Carolina
Study officials:
affiliation: Syneos Health
name: Jessica D Albano, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vannappagari V, Albano JD, Koram N, Tilson H, Scheuerle AE, Napier MD. Prenatal exposure to zidovudine and risk for ventricular septal defects and congenital heart defects: data from the Antiretroviral Pregnancy Registry. Eur J Obstet Gynecol Reprod Biol. 2016 Feb;197:6-10. doi: 10.1016/j.ejogrb.2015.11.015. Epub 2015 Nov 24.
citation: Vannappagari V, Koram N, Albano J, Tilson H, Gee C. Association between in utero zidovudine exposure and nondefect adverse birth outcomes: analysis of prospectively collected data from the Antiretroviral Pregnancy Registry. BJOG. 2016 May;123(6):910-6. doi: 10.1111/1471-0528.13542. Epub 2015 Aug 12.