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Informed Consent documents are in the process of being updated to be compliant with the revised Common Rule.

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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…

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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.

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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…

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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).

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Letter of amendment flowchart for Protocol Teams.

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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…

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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).

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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…

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The following serious side effects have been associated with the use of maraviroc:

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Depo-Provera CI is a progestin indicated only for the prevention of pregnancy.

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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…

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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…

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Contains training materials from MTN annual meeting including presenation slides and case study. Meeting was held in March 2016.

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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…

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