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Trial NCT00000655

Resource URI: http://static.linkedct.org/resource/trials/NCT00000655
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linkedct:brief_title A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/3124>
linkedct:condition <http://static.linkedct.org/resource/condition/10223>
linkedct:condition <http://static.linkedct.org/resource/condition/5486>
linkedct:criteria Inclusion Criteria Patient must have the following: - Presumptive diagnosis of AIDS as defined by the CDC. - Untreated Pneumocystis carinii pneumonia (PCP). - Willingness and ability to give informed consent. Prior Medication: Allowed: - Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) including aerosolized pentamidine or sulfamethoxazole/trimethoprim (SMX/TMP) (at a dose no greater than two DS tablets twice daily). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Judged by the investigator to be in impending respiratory failure. - Malabsorption or vomiting that would, in the judgment of investigator, potentially limit the retention and absorption of an oral therapy. - Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult. Concurrent Medication: Excluded: - Corticosteroid treatment (except replacement therapy or patients in Group B). - Ganciclovir. - Zidovudine (AZT). - Investigational agents including antiretroviral agents (didanosine (ddI), dideoxycytidine (ddC), etc.). Drugs likely to have anti-pneumocystis effect such as: - Sulfonamides. - Pentamidine. - Dapsone. - Trimethoprim. - Other DHFR inhibitors. - Primaquine. - Clindamycin. - Sulfonylureas. Patients with the following are excluded: - Judged by the investigator to be in impending respiratory failure. - Prior therapy for this episode of PCP or treatment within 4 weeks of entry for a prior episode of PCP. - Unable to or refuse to discontinue zidovudine, ganciclovir, or other antiretroviral agents during the 21 day treatment period. - Unable to take medication orally or unwilling or unable to take study medication with food. - Significant psychosis or emotional disorder such that, in the investigator's opinion, the patient would not be compliant with the study protocol. - Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency. - Prior history of life-threatening toxicity to SMX/TMP such as severe rash or Stevens-Johnson syndrome. Prior Medication: Excluded: - Prior therapy for this episode of Pneumocystis carinii pneumonia (PCP) or treatment within 4 weeks for a prior episode of PCP. - Blood transfusions.
linkedct:description Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients. Patients are randomized into one of two treatment groups to receive either (1) 566C80 for 21 days, or (2) SMX/TMP for 21 days. Patients will be stratified according to severity of PCP. Group A will be those with an arterial-alveolar (A-a) DO2 < 35 mm Hg. Group B will have an A-a DO2 of 35-45 mm Hg., and will also be required to receive therapy with Corticosteroids. All doses are taken with food. During the 21 days of treatment, patients are examined clinically for adverse effects and have hematology (blood-related) and clinical chemistry studies conducted a minimum of 2 times weekly. More frequent monitoring may be required at the discretion of the investigator. To evaluate the effectiveness of study medication, the clinical status of each patient is evaluated 2 to 3 times per week (e.g., dyspnea score, cough score, chest tightness/pain score, vital signs). Also, on days 7 and 21 of treatment, an arterial blood gas measurement and chest X-ray are performed. Patients who experience severe toxicities will be discontinued from the study and placed on alternative therapy. Patients will also be removed from study if they show significant clinical deterioration within the first 7 days of therapy or if there is no improvement after 10 days of therapy. This study involves a double placebo with one group randomized to receive oral 566C80 and placebo tablets which look like SMX/TMP while the other group will receive SMX/TMP and placebo tablets looking like 566C80.
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 N/A
linkedct:eligibility_minimum_age 13 Years
linkedct:enrollment 300 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000655
rdfs:label Trial NCT00000655
linkedct:lastchanged_date July 29, 2008
linkedct:lead_sponsor_agency National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:location <http://static.linkedct.org/resource/location/105222>
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linkedct:nct_id NCT00000655
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients
linkedct:org_study_id ACTG 167
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/23218>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000655>
linkedct:phase Phase 2
linkedct:reference <http://static.linkedct.org/resource/reference/1717>
linkedct:reference <http://static.linkedct.org/resource/reference/49052>
linkedct:secondary_id FDA 53A
linkedct:secondary_id NIAID 90-CC-185
linkedct:secondary_id Project P71
linkedct:secondary_id Protocol #03
linkedct:source National Institute of Allergy and Infectious Diseases (NIAID)
linkedct:study_design Treatment, Parallel Assignment, Safety Study
linkedct:study_type Interventional
linkedct:summary To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.
rdf:type linkedct:trials
linkedct:verification_date March 1992