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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.

Recruiting · NCT00404989

Conditions: HIV Infections, Hepatitis B

At a glance

Research payments reported, 2025
$1,662
U.S. investigators named
0
Sites paid
0
Planned or actual enrollment
24,258

About the trial

Sponsor
Syneos Health (with 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.)
Dates
Started 1989-01; completion 2099-01
Results posted
Not yet

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 …

From ClinicalTrials.gov, last updated 2025-04-01. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Apotex Inc. reported $1,662 in research payments for this study in 2025 (42 payments).

Products named: Lamivudine, Darunavir, Adefovir Dipivoxil

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

Sites paid to run it

  • $1,662

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.