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The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults. In those with an undetectable viral load, a once daily combination of FTC, ddI, efavirenz would be easier to take, with less side effects and the same efficacy. The aim of the study was to evaluate if the once daily combination presents the same efficacy than the HAART therapy with less side effects and a better adherence.
The combination of two nucleoside analogues and one protease inhibitor is a highly active antiretroviral therapy (HAART) in HIV infected adults, but side effects an the great number of pills induces less adherence to the therapy. Once daily combination with a lower number of pills could be more easy to take, with a greater adherence, less side effects, and the same efficacy. 355 patients are recruited in the study, randomized in two treatment groups: maintenance of the HAART therapy versus changing for a once daily combination of FTC, ddI, efavirenz, during 48 weeks. The primary end-point is the viral success maintained until 48 weeks. Secondary end-point is the safety and adherence.
The trial is prolonged for a total of 48 weeks.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
emtricitabine, FTC (drug), didanosine, ddI (drug), efavirenz (drug)
French National Agency for Research on AIDS and Viral Hepatitis
Published on BioPortfolio: 2014-08-27T03:49:50-0400
The purpose of this study is to compare the safety and effectiveness of emtricitabine and stavudine when given with didanosine plus efavirenz to HIV-infected patients.
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Inhibitor or Reverse Transcriptases or of RNA-dIrected DNA polymerase.
A pharmaceutical preparation of emtricitabine and tenofovir that is used as an ANTI-HIV AGENT in the treatment and prevention of HIV INFECTIONS.
Forms to which substances are incorporated to improve the delivery and the effectiveness of drugs. Drug carriers are used in drug-delivery systems such as the controlled-release technology to prolong in vivo drug actions, decrease drug metabolism, and reduce drug toxicity. Carriers are also used in designs to increase the effectiveness of drug delivery to the target sites of pharmacological actions. Liposomes, albumin microspheres, soluble synthetic polymers, DNA complexes, protein-drug conjugates, and carrier erythrocytes among others have been employed as biodegradable drug carriers.
A pharmaceutical preparation that contains emtricitabine, rilpivirine and tenofovir disoproxil fumarate. It is used to treat HIV INFECTIONS.
Diminished or failed response of an organism, disease or tissue to the intended effectiveness of a chemical or drug. It should be differentiated from DRUG TOLERANCE which is the progressive diminution of the susceptibility of a human or animal to the effects of a drug, as a result of continued administration.
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Human Immuno Deficiency Virus (HIV)
Human Immunodeficiency Virus (HIV), the causative agent of AIDS. The Human Immunodeficiency Virus, more commonly known as HIV, is a member of the lentivirus sub-set of the retrovirus family of pathogens. It causes AIDS, or Acquired Immuno Deficiency Sy...
AIDS and HIV
AIDS; Acquired Immune Deficiency Syndrome. HIV; Human Immunodeficiency Virus HIV infection causes AIDS. HIV infection also causes the production of anti-HIV antibodies, which forms the test for HIV in patients. People who have the HIV antibodies are ...