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The purpose of this study is to show that the administration of 400/mg/m2/day of didanosine(ddI) during the meal is bioequivalent to the administration of 240/mg/m2/day of didanosine during fasting, in HIV infected children treated by a ARV combination including ddI
The didanosine is one of the reverse transcriptase inhibitors. This drug is efficient against the viral replication of the HIV. Licensing for the children was obtained in June, 1992. The main problem of the didanosine is its poor bioavailability: although gastro-resistant capsules were developed, its bioavailability remains dependent on alimentation. Taking a meal 1-2 hours before the administration of ddI leads to a reduction of 50% of its bioavailability as well for the child as for the adult. It is therefore recommended to take ddI during fasting period. This regimen in some cases can decrease therapeutic observance. A pharmacokinetic study of ddI will be conducted during the meal with 240 mg/m2/day during fasting period compare to 400 mg/m2/day during the meal. 26 patients, aged more than 6 years old, will be included and randomised in 2 groups. The first group will take the standard dose of ddI during 28 days during fasting period (phase A), then the high dose during the meal during 28 days (phase B). The second group will take first the phase B and secondly the phase A. Patients will be sequentially evaluated both after the first and the second period of treatment for pharmacokinetics and biological analysis.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Assistance Publique - Hôpitaux de Paris
Published on BioPortfolio: 2014-08-27T03:31:00-0400
The purpose of this study is to see if the coated-capsule form of didanosine (ddI) is as safe and absorbed by the body as well as the chewable-tablet form of ddI. Didanosine (ddI) is an a...
The purpose of this study is to compare the effectiveness of taking didanosine (ddI) once a day plus stavudine (d4T) twice a day with taking ddI twice a day plus d4T twice a day. This stud...
The purpose of this study is to see if it is safe and effective to give efavirenz plus stavudine plus didanosine to HIV-infected patients who have never received anti-HIV treatment.
Didanosine is an effective anti-HIV drug, but it can cause stomach upset. This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach more easily and h...
The purpose of this study is to see if it is safe and effective to give MKC-442, didanosine (ddI), stavudine (d4T), and delavirdine (DLV) to HIV-positive patients.
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A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. Didanosine is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA by binding to reverse transcriptase; ddI is then metabolized to dideoxyadenosine triphosphate, its putative active metabolite.
A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by a hydrogen. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is an inhibitor of HIV replication, acting as a chain-terminator of viral DNA by binding to reverse transcriptase. Its principal side effect is nephrotoxicity. In vivo, dideoxyadenosine is rapidly metabolized to DIDANOSINE (ddI) by enzymatic deamination; ddI is then converted to dideoxyinosine monophosphate and ultimately to dideoxyadenosine triphosphate, the putative active metabolite.
Inflammation of brain parenchymal tissue as a result of viral infection. Encephalitis may occur as primary or secondary manifestation of TOGAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; BUNYAVIRIDAE INFECTIONS; PICORNAVIRIDAE INFECTIONS; PARAMYXOVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RETROVIRIDAE INFECTIONS; and ARENAVIRIDAE INFECTIONS.
Viral infections of the leptomeninges and subarachnoid space. TOGAVIRIDAE INFECTIONS; FLAVIVIRIDAE INFECTIONS; RUBELLA; BUNYAVIRIDAE INFECTIONS; ORBIVIRUS infections; PICORNAVIRIDAE INFECTIONS; ORTHOMYXOVIRIDAE INFECTIONS; RHABDOVIRIDAE INFECTIONS; ARENAVIRIDAE INFECTIONS; HERPESVIRIDAE INFECTIONS; ADENOVIRIDAE INFECTIONS; JC VIRUS infections; and RETROVIRIDAE INFECTIONS may cause this form of meningitis. Clinical manifestations include fever, headache, neck pain, vomiting, PHOTOPHOBIA, and signs of meningeal irritation. (From Joynt, Clinical Neurology, 1996, Ch26, pp1-3)
Infections with viruses of the family PARAMYXOVIRIDAE. This includes MORBILLIVIRUS INFECTIONS; RESPIROVIRUS INFECTIONS; PNEUMOVIRUS INFECTIONS; HENIPAVIRUS INFECTIONS; AVULAVIRUS INFECTIONS; and RUBULAVIRUS INFECTIONS.
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Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...