Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients
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|ClinicalTrials.gov Identifier: NCT00000730|
Recruitment Status : Terminated
First Posted : August 31, 2001
Last Update Posted : May 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia, Pneumocystis Carinii HIV Infections||Drug: Trimetrexate glucuronate Drug: Methylprednisolone Drug: Pentamidine isethionate Drug: Sulfamethoxazole-Trimethoprim Drug: Leucovorin calcium||Phase 3|
There is at present no scientific information about the best treatment for an AIDS patient with PCP who is not improving while receiving the standard therapies (SMX/TMP or PEN). New drug treatments are available, including steroid therapy and TMTX, but there is no information proving that these new treatments work better than the standard therapies.
Hospitalized patients who have failed to respond to at least 4 full days but no greater than 14 full days of therapy with SMX/TMP or PEN are randomly placed into one of three study groups. Patients are stratified for (1) mechanical ventilation at enrollment, (2) prior zidovudine therapy of at least 4 weeks duration, and (3) first versus subsequent episode of PCP. One group of patients receives TMTX by intravenous infusion for 21 days and LCV for 24 days. The second and third group of patients receive either PEN or SMX/TMP depending on which therapy they have already received and not improved on. The difference between the second and third group is that the second group receives the conventional therapy (PEN or SMX/TMP) and a placebo (inactive medication) and the third group receives the conventional therapy and prednisolone. Neither investigators nor patients know whether patients receive methylprednisolone. Patients continue study treatment until a study end point is reached or for a minimum of 21 days (unless there is toxicity).
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||240 participants|
|Official Title:||A Randomized, Comparative Trial of Trimetrexate With Leucovorin Rescue Versus Standard Anti-Pneumocystis Therapy Versus Standard Anti-Pneumocystis Therapy With High Dose Steroids for AIDS Patients With Pneumocystis Pneumonia Who Appear to Be Refractory to Conventional Drugs|
|Actual Study Completion Date :||March 1989|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000730
|United States, South Carolina|
|West Columbia, South Carolina, United States, 29169|
|Study Chair:||Masur H|