Home | All trials

[RDF data]
Trial NCT00000739

Resource URI: http://static.linkedct.org/resource/trials/NCT00000739
PropertyValue
linkedct:brief_title Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5445>
linkedct:condition <http://static.linkedct.org/resource/condition/10223>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Concurrent Medication: Allowed: - Rifampin and rifampin derivatives for up to 1 week during the study. - Rifabutin or other drugs that could alter dapsone metabolism (if prescribed by the child's primary care physician). Patients must have: - Evidence of HIV infection. PER AMENDMENT 11/16/95: - Children who require prophylaxis. (Was written - Risk of developing PCP.) - Known intolerance to TMP / SMX. - Consent of parent or guardian. Patients entering this study may be co-enrolled in other ACTG pediatric studies. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Glucose-6-phosphate dehydrogenase deficiency. - Known allergy to dapsone. Concurrent Medication: Excluded: - Rifampin, rifampin derivatives, or oxidant drugs for more than 1 week. Patients with the following prior conditions are excluded: - Serious or life-threatening reactions to TMP / SMX (e.g., anaphylaxis, Stevens-Johnson syndrome, hypotension) that would contraindicate therapy with sulfa drugs. Prior Medication: Excluded: - Prior dapsone. - Rifampin, rifampin derivatives, or oxidant drugs within 1 week prior to study entry. - TMP / SMX within 7 days prior to study entry (and toxicity must be clearly resolving). Prior Treatment: Excluded: - RBC transfusion within 4 weeks prior to study entry.
linkedct:description Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established. Ninety-six HIV-infected infants and children who are intolerant to trimethoprim / sulfamethoxazole ( TMP / SMX ) are randomized to receive oral dapsone in a lower dose once daily or at a higher dose once weekly. Treatment continues until the last patient enrolled has received at least 3 months of therapy. Blood samples are drawn between weeks 4 and 8, at weeks 12 and 24, and every 3 months thereafter during dapsone administration.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 12 Years
linkedct:eligibility_minimum_age 1 Month
linkedct:enrollment 96 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000739
rdfs:label Trial NCT00000739
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency Jacobus Pharmaceutical
linkedct:location <http://static.linkedct.org/resource/location/105307>
linkedct:location <http://static.linkedct.org/resource/location/146815>
linkedct:location <http://static.linkedct.org/resource/location/147071>
linkedct:location <http://static.linkedct.org/resource/location/147780>
linkedct:location <http://static.linkedct.org/resource/location/147801>
linkedct:location <http://static.linkedct.org/resource/location/151057>
linkedct:location <http://static.linkedct.org/resource/location/151122>
linkedct:location <http://static.linkedct.org/resource/location/152674>
linkedct:location <http://static.linkedct.org/resource/location/152714>
linkedct:location <http://static.linkedct.org/resource/location/152982>
linkedct:location <http://static.linkedct.org/resource/location/153259>
linkedct:location <http://static.linkedct.org/resource/location/153326>
linkedct:location <http://static.linkedct.org/resource/location/153759>
linkedct:location <http://static.linkedct.org/resource/location/153763>
linkedct:location <http://static.linkedct.org/resource/location/153882>
linkedct:location <http://static.linkedct.org/resource/location/153995>
linkedct:location <http://static.linkedct.org/resource/location/154169>
linkedct:location <http://static.linkedct.org/resource/location/154417>
linkedct:location <http://static.linkedct.org/resource/location/154945>
linkedct:location <http://static.linkedct.org/resource/location/155085>
linkedct:location <http://static.linkedct.org/resource/location/155200>
linkedct:location <http://static.linkedct.org/resource/location/155960>
linkedct:location <http://static.linkedct.org/resource/location/156523>
linkedct:location <http://static.linkedct.org/resource/location/157323>
linkedct:location <http://static.linkedct.org/resource/location/160320>
linkedct:location <http://static.linkedct.org/resource/location/160713>
linkedct:location <http://static.linkedct.org/resource/location/161675>
linkedct:location <http://static.linkedct.org/resource/location/161840>
linkedct:location <http://static.linkedct.org/resource/location/165064>
linkedct:location <http://static.linkedct.org/resource/location/166682>
linkedct:location <http://static.linkedct.org/resource/location/167197>
linkedct:location <http://static.linkedct.org/resource/location/168932>
linkedct:location <http://static.linkedct.org/resource/location/170081>
linkedct:location <http://static.linkedct.org/resource/location/171716>
linkedct:location <http://static.linkedct.org/resource/location/174045>
linkedct:location <http://static.linkedct.org/resource/location/177835>
linkedct:location <http://static.linkedct.org/resource/location/179912>
linkedct:location <http://static.linkedct.org/resource/location/183878>
linkedct:location <http://static.linkedct.org/resource/location/186734>
linkedct:location <http://static.linkedct.org/resource/location/192654>
linkedct:location <http://static.linkedct.org/resource/location/192811>
linkedct:location <http://static.linkedct.org/resource/location/192981>
linkedct:location <http://static.linkedct.org/resource/location/193168>
linkedct:location <http://static.linkedct.org/resource/location/197412>
linkedct:location <http://static.linkedct.org/resource/location/201928>
linkedct:location <http://static.linkedct.org/resource/location/205665>
linkedct:location <http://static.linkedct.org/resource/location/210066>
linkedct:location <http://static.linkedct.org/resource/location/210953>
linkedct:location <http://static.linkedct.org/resource/location/211419>
linkedct:location <http://static.linkedct.org/resource/location/211745>
linkedct:location <http://static.linkedct.org/resource/location/213279>
linkedct:location <http://static.linkedct.org/resource/location/217340>
linkedct:location <http://static.linkedct.org/resource/location/220112>
linkedct:nct_id NCT00000739
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
linkedct:org_study_id ACTG 179
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10511>
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/39896>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/3038>
foaf:page <http://clinicaltrials.gov/show/NCT00000739>
linkedct:phase Phase 1
linkedct:reference <http://static.linkedct.org/resource/reference/2457>
linkedct:reference <http://static.linkedct.org/resource/reference/2458>
linkedct:reference <http://static.linkedct.org/resource/reference/4613>
linkedct:reference <http://static.linkedct.org/resource/reference/9170>
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Parallel Assignment, Pharmacokinetics Study
linkedct:study_type Interventional
linkedct:summary Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children. Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP ) breakthrough in children receiving two different dose regimens of dapsone. Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established.
rdf:type linkedct:trials
linkedct:verification_date November 1999