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

HIV Infections Clinical Trial

— APR  

Official title:

Antiretroviral Pregnancy Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00404989
• Other study ID #: APR
• Status: Recruiting
• Start date: January 1989
• Est. completion date: January 2099

Study information

• Verified date: June 2024
• Source: Syneos Health
• Contact: Taylor Cook
• Phone: 800-258-4263
• Email: SM_APR[@]APRegistry.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

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®, 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).

Other known NCT identifiers

• NCT01137981

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24258
• Est. completion date: January 2099
• Est. primary completion date: January 2099
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• HIV Infections

Locations

Country	Name	City	State
United States	Registry Coordinating Center	Wilmington	North Carolina

Sponsors (26)

Lead Sponsor

Collaborator

Syneos Health

AbbVie, Alvogen Korea, 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 Shasun Limited, Teva Pharmaceuticals USA, ViiV Healthcare

Country where clinical trial is conducted

United States, 

External Links

•   Download: data forms to register patients, Semi-Annual Interim Report, product package inserts, organizational links, guidelines, bibliography