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Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy) Package Insert...
Cabotegravir and Rilpivirine (Cabenuva)...
Estradiol...
Doravirine (Pifeltro)...
Linezolid (Zyvox)...
TRUVADA is a combination of EMTRIVA and VIREAD, both nucleoside analog HIV-1 reverse transcriptase inhibitors.TRUVADA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. TRUVADA is indicated in…
RETROVIR is a nucleoside analogue reverse transcriptase inhibitor indicated for:* Treatment of Human Immunodeficiency Virus (HIV-1) infection in combination with other antiretroviral agents. (1.1) * Prevention of maternal-fetal HIV-1 transmission. (1.2)
NORVIR is an HIV protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
EDURANT is a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated - in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients with HIV-1 RNA less than or equal to 100,000 copies/…
The rectal grading table was initiated by a group of researchers who developed and used it. They subsequently discovered items that needed revision through use in several protocols. The revisions have been approved by DAIDS. A summary of the changes include the following and have been incorporated…
Contains training materials from MTN annual meeting including presenation slides and case study. Meeting was held in March 2016.
The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 contains a number of parameter level (i.e., adverse event) severity grading criteria changes detailed below when compared with the Division of AIDS Table for Grading the S everity of Adult…
The Division of AIDS Table for grading the severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) is a collection of commonly encountered adverse events and their descriptive terminology utilized for severity grading. As part of its standard review processes, DAIDS reassessed the “…
This form is to document that the signator of this document is authorized to use the DAIDS-ES system, and understands that their electronic signature (eSignature) is used to electronically sign database records.
Guidance table for grading the severity of adult and pediatric adverse events with rectal involvement during microbicide studies.
.zip file contains:
Case review on adverse events
Safety training presentations on adverse events, expedited reporting and assessment,
Expedited reporting via DAERS
a safety training case study handout
Training given in the Republic of South Africa in October 2016.
This clarification of the DAIDS Table for Grading the Severity of Adult and Pediatric AE’s provides additional explanation of the DAIDS AE Grading Table and clarifies some of the parameters.
About the DAIDS RSC Safety Team
The DAIDS RSC Safety Team receives expedited adverse events (EAEs) reported by Clinical Research Sites (CRSs) participating in DAIDS-supported studies, processes the events for review by the DAIDS Medical Officer, and prepares the reports for submission to the Food…
The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events consists of parameters, or Adverse Events (AEs), with severity grading guidance that are to be used in DAIDS clinical trials for safety data reporting to maintain accuracy and consistency in the…
The U.S. Code of Federal Regulations (CFR) defines procedures and requirements governing the use of investigational new agents regulated by the U.S. Food and Drug Administration (FDA), including the monitoring and reporting of serious adverse events (21 CFR 312). The Division of AIDS (DAIDS) of the…
Safety Information pertains to the safety profile of study products (drug, vaccine, or device) and is intended to be used by the CRSs that are involved in DAIDS-supported studies. Information conveyed through the DAIDS RSC Safety Information Center (RIC) comes from drug company collaborators (…
The DAIDS Adverse Experience Reporting System (DAERS) is an internet-based system used by DAIDS Clinical Research Sites (CRSs) to report Expedited Adverse Events (EAEs) to DAIDS. DAERS creates a centralized location for accessing EAE information for reporting purposes.
All CRSs must have access to…
NOTE: Do not use unless you have a DAERS access emergency.
Division of AIDS Safety Office Expedited Adverse Event (EAE) Form (Version 2.0 - April 2010)
Completion Instructions for the DAIDS EAE Form (Version 2.0 - April 2010)
Safety Training is conducted for personnel affiliated with DAIDS-supported studies to promote an understanding of DAIDS policies and procedures related to the expedited reporting of adverse events to DAIDS.
Safety Workshops
Safety Workshop - South Africa (October 2016)
Training to Obtain…
Note that these trainings were conducted on a specific date for a particular audience. They may not be applicable to your activities or may not contain the most current information.
Safety Workshop
DAIDS Safety Workshop Durban SA (Nov 2015)
ZIP, 4.19 MB January 25, 2016
DAIDS Safety Workshop…
This DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected version 2.1, July 2017 supersedes version 2.1 of the table dated March 2017.
Changes to note in this corrected version 2.1 of the Severity Grading Table are parameter specific and are highlighted below in…
Instructions for using the Table for Grading the Severity of Adult and Pediatric Adverse Events. Corrected version 2.1, July 2017
Instructions for using the Table for Grading the Severity of Adult and Pediatric Adverse Events. Changes highlighted, Corrected version 2.1, July 2017
Investigator's Brochure (IB) Table...
Please note the following when using Package Inserts from this web site:
The drug labels and other drug-specific information on this website represent the most recent drug listing information that companies have provided to, or which is obtainable by, the Division of AIDS, NIAID, NIH (“DAIDS”), and…
SIRTURO is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adults (18 years and older) with pulmonary multi-drug resistant tuberculosis (MDR-TB). Reserve SIRTURO for use when an effective treatment regimen cannot otherwise be provided. Administer SIRTURO by…
TIVICAY is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 30 kg.
Efavirenz capsules are a non-nucleoside reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection.
ATRIPLA, a combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse transcriptase inhibitor, is indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and…
GENVOYA is a four-drug combination of elvitegravir, an HIV-1 integrase strand transfer inhibitor (INSTI), cobicistat, a CYP3A inhibitor, and emtricitabine and tenofovir alafenamide (TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated as a complete regimen…
DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12…
DIFLUCAN (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension.
HARVONI is a fixed-dose combination of ledipasvir, a hepatitis C virus (HCV) NS5A inhibitor, and sofosbuvir, an HCV nucleotide analog NS5B polymerase inhibitor, and is indicated for the treatment of chronic hepatitis C virus (HCV).
KALETRA is an HIV-1 protease inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients (14 days and older).
Depo-Provera CI is a progestin indicated only for the prevention of pregnancy.
DAIDS Core Risk List (side effects/risks of study drug) for Dolutegravir (DTG) version 2.0, September 2018
The DAIDS Core Risk Lists provides the DAIDS Medical Officer with a list of recommended risks (side effects) that will be used in the DAIDS Sample Informed Consent (SIC) Form. The list draws…
No new or unexpected side effects are observed with the fixed dose combination of EFV 600 mg/FTC 200 mg/TDF 300 mg tablet than those observed when each drug is given separately.
The following side effects have been associated with the use of efavirenz:
A small number of people may experience the following serious psychiatric problems:
Depression, which may be severe
Suicidal thoughts or attempts (rarely)
Aggressive behavior
Psychosis-like symptoms, such as abnormal…
The following serious side effects are associated with the use of lopinavir/ritonavir:
Abnormal heart rhythm and electrocardiogram (EKG) changes. These changes can lead to serious heart problems. Your risk for these problems may be higher if you:
Already have a history of abnormal heart rhythm or…
The following side effects have also been associated with use of lamivudine: If you are infected with both Hepatitis B and HIV, you should be aware that your liver function tests may increase, and symptoms associated with hepatitis (an acute inflammation of the liver) may worsen if lamivudine is…
The following side effects have been associated with the use of raltegravir:
Serious skin and allergic reactions including a rash which can become severe or life-threatening and can be fatal. If you develop a rash with any of the following symptoms stop using raltegravir and contact your Health…
The following side effects have been associated with the use of rifapentine:
Reddish coloring of urine, sweat, sputum, saliva, tears, and breast milk. Stains to your contact lenses and dentures that may not go away.
Liver damage; if you develop any of the following symptoms, you should call your…
The following side effects have been associated with the use of tenofovir:
Upset stomach, vomiting, gas, loose or watery stools
Generalized weakness
Dizziness
Depression
Headache
Abdominal pain
Worsening or new kidney damage or failure
Liver problems. If you are developing liver problems, you may…
No new or unexpected side effects are observed with the FTC 200 mg/TDF 300 mg combination tablet than those observed when each drug is given separately.
The following side effects have been associated with use of zidovudine:
Decrease in the number of white blood cells that help fight infection
Decrease in the number of red blood cells that may cause weakness, dizziness, and fatigue
Muscle aches, weakness, and wasting
Headache
Upset stomach…
The following serious side effects have been associated with the use of darunavir given together with ritonavir (RTV). Contact your healthcare provider if you have any of the symptoms of liver problems that are listed and any skin changes with the symptoms listed below.
People taking darunavir…
The Division of AIDS (DAIDS) was formed in 1986 to develop and implement the national research agenda to address the HIV/AIDS epidemic. Toward that end, the Division supports a global research portfolio on HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating…
DAIDS ProPEP is a branch of DAIDS within the Office of Policy in Clinical Research Operations (OPCRO). DAIDS ProPEP provides subject matter expertise on human subjects protections matters (i.e., 45 CFR 46, 21 CFR 50, and 21 CFR 56), IRB/EC requirements, and HSP/GCP compliance issues. ProPEP…
The DAIDS Protocol Registration Team (PRT) is a Team within OPCRO responsible for managing the Protocol Registration (PR) process, which includes oversight of the DAIDS RSC PRO.
The process of completing and submitting the site-specific informed consent, IRB/EC approval letter, FDA 1572 Form,…
Placeholder for DAIDS Regulatory Support Center (RSC)
Temporary importation of Bleomycin Sulfate Powder for Injection, 15,000 International Units (IU) to address drug shortage issue
COMBIVIR, a combination of 2 nucleoside analogue reverse transcriptase inhibitors, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.
INTELENCE® is a human immunodeficiency virus type 1 (HIV-1) non-nucleoside reverse transcriptase inhibitor(NNRTI) indicated for treatment of HIV-1 infection in treatment-experienced patients 6 years of age and older with viral strains resistant to an NNRTI and other antiretroviral agents.
Isoniazid is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, lactose monohydrate, pregelatinized starch (corn), povidone and stearic acid.
The fixed-dose combination (Efavirenz 600 mg/ Emtricitabine 200 mg/Tenofovir disoproxil fumarate 300 mg) is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults.
Bleomycin for Injection should be considered a palliative treatment. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents.
Vepesid is used in the treatment of certain types of cancer, in particular small cell lung cancer and testicular cancer.
Therapeutic Indications:
Ovarian carcinoma: in the first-line chemotherapy of ovarian cancer, paclitaxel is indicated for the treatment of patients with advanced carcinoma of the ovary or with residual disease (> 1 cm) after initial laparotomy, in combination with (cisplatin or carboplatin)In…
ISENTRESS is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated: * In combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 4 weeks of age and older (1). The use of other active agents with ISENTRESS is associated with…
Ribasphere is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients…
Ribavirin is a nucleoside analogue indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with peginterferon alfa-2a in patients 5 years of age and older with compensated liver disease not previously treated with interferon alpha, and in adult CHC patients…
PRIFTIN is a rifamycin antimycobacterial drug indicated in patients 12 years of age and older for the treatment of active pulmonary tuberculosis (TB) caused by Mycobacterium tuberculosis in combination with one or more anti-tuberculosis (anti-TB) drugs to which the isolate is susceptible. (1.1) *…
VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. VIREAD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. (1) VIREAD is indicated…
SEPTRA (trimethoprim and sulfamethoxazole) is a synthetic antibacterial combination product. Each SEPTRA Tablet contains 80 mg trimethoprim and 400 mg sulfamethoxazole and the inactive ingredients docusate sodium (0.4 mg per tablet), FD&C Red No. 40, magnesium stearate, povidone, and sodium…
Vincristine sulfate injection is indicated in acute leukemia. Vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in Hodgkin’s disease, non–Hodgkin’s malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms’ tumor.
MYCOBUTIN Capsules for oral administration contain 150 mg of the rifamycin antimycobacterial agent rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white…
Rifampin is indicated in the treatment of all forms of tuberculosis.
Presentation on expedited reporting to DAIDS plus a case study on expedited reporting via DAERS.
Guidance table for grading the severity of adult and pediatric adverse events with female genital involvement during microbicide studies.
Guidance table for grading the severity of adult and pediatric adverse events with male genital involvement during microbicide studies.
Line by line instructions for how to complete the Expedited Adverse Events reporting form.
Term definitions and access rights for Reporters and Submitters using DAERS.
Formatted specifically for printing. applicable, to special instructions to keep in mind while entering values.
Technical guide to the DAERS system for Site Enrollment users.
Detailed manual on the DAERS system for Site Reporters and Study Physicians.
Instructions for using the Table for Grading the Severity of Severity of Adult and Pediatric Adverse Events version 2.0. This version does not visually show changes with highlighting.
Instructions for using the Table for Grading the Severity of Severity of Adult and Pediatric Adverse Events version 2.0. Changes are highlighted visually within the document.
Expedited reporting form for Adverse Events fillable using Microsoft Word.
Presentation from webinar on using the Table for Grading the Severity of Adult and Pediatric Adverse Events Version 1.0.
Use this to make sure you don't miss any required pieces of information when recording and reporting an adverse event.
One-sheet references for writing a narrative case summary of an adverse event and for evaluation and follow-up.
Zip file contains:
Presentation slides from ACTG June 2014 network meeting
Presentation to ACTG about expedited reporting on Adverse Events
Presentation to ACTG about reporting via DAERS
Case study on Adverse Events
Case Study on chest pain
.zip file contains:
Presentation slides from November 2014 webinar training on adverse events
Study handout accompanying training
Presentation about expedited reporting on Adverse Events
Presentation about reporting via DAERS
Case study on Adverse Events
Case Study on chest pain
Definitions of the types of safety information distributed by DAIDS and methods of distribution.
Training workshop in Durban, SA supporting documents:
Case Review: All About AEs - Safety Training
Expedited Reporting and Assessment - Safety Training
Expedited Reporting via DAERS - Safety Training
Expedited reporting via DAERS - Case Study
Training workshop in Johannesburg, SA supporting documents:
Case Review: All About AEs - Safety Training
Expedited Reporting and Assessment - Safety Training
Expedited Reporting via DAERS - Safety Training
Expedited reporting via DAERS - Case Study
The Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 contains a number of changes detailed below when compared with the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0 – December 2004 (…
Tutorial guide, with screenshots, for the DAIDS-ES system.
.zip files contains
Presentation to HPTN/IMPAACT Annual Meeting on Expedited Reporting to DAIDS and DAERS refresher course
Expedited reporting via DAERS - Case Study
.zip file contains:
Presentation to HVTN Annual Meeting on Expedited Reporting to DAIDS and DAERS refresher course;
Expedited reporting via DAERS - Case Study
.zip files contains:
Safety training presentation on expedited reporting to DAIDS and a refresher on DAERS
Case study handout
Meeting for HPTN and IMPAACT networks was held June 2016.
This manual applies to all DAIDS-supported and/or -sponsored clinical trials, unless the DAIDS Office for Policy in Clinical Research Operations (OPCRO) Director or designee has delegated the responsibility for expedited adverse event (EAE) reporting to another entity (e.g., a pharmaceutical or…
DAIDS has developed clarifications for the "DAIDS AE Grading Table" in order to address questions and comments received from site investigators, Operations Offices, Statistical and Data Management Centers, and Medical Officers within the Division. The subsequent clarifications have been outlined in…
Guidelines for Electronic Submissions Via Email-EPR Guidelines
Monthly Comprehensive Safety Distribution Report (CSDR) FAQ...