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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001014 |
To compare the safety and effectiveness of an investigational drug therapy (trimetrexate plus leucovorin calcium) with that of conventional therapy (sulfamethoxazole-trimethoprim) in the treatment of moderately severe Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection. New treatments are needed to reduce the mortality rate from PCP in AIDS patients and to reduce the high relapse rate found after conventional therapy. Trimetrexate (TMTX) was chosen for this trial because it was found to be much more potent than sulfamethoxazole/trimethoprim (SMX/TMP) against the PCP organism in laboratory tests. Also TMTX, in combination with leucovorin (LCV), did not cause severe toxicity in a preliminary trial. It is believed that TMTX will be more effective in treating PCP and in preventing a recurrence of PCP.
Condition | Intervention | Phase |
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Trimetrexate glucuronate Drug: Sulfamethoxazole-Trimethoprim Drug: Leucovorin calcium |
Phase III |
MedlinePlus related topics: | AIDS Pneumonia |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment |
Official Title: | A Randomized, Comparative, Double-Blind Trial of Trimetrexate (CI-898) With Leucovorin Calcium Rescue Versus Trimethoprim / Sulfamethoxazole for Moderately Severe Pneumocystis Carinii Pneumonia in Patients With AIDS |
Estimated Enrollment: | 302 |
New treatments are needed to reduce the mortality rate from PCP in AIDS patients and to reduce the high relapse rate found after conventional therapy. Trimetrexate (TMTX) was chosen for this trial because it was found to be much more potent than sulfamethoxazole/trimethoprim (SMX/TMP) against the PCP organism in laboratory tests. Also TMTX, in combination with leucovorin (LCV), did not cause severe toxicity in a preliminary trial. It is believed that TMTX will be more effective in treating PCP and in preventing a recurrence of PCP.
Patients entered in the study are randomly assigned to trimetrexate / leucovorin (TMTX / LCV) or to sulfamethoxazole/trimethoprim (SMX/TMP) for a 21-day trial. For the first 10 days, the trial is double-blind (neither patient nor physician knows which drugs the patient is receiving), and drugs are given by intravenous infusion. TMTX is given once every 24 hours and LCV every 6 hours; SMX/TMP is given every 6 hours. Doses are determined by body size. After the first 10 days, LCV and SMX/TMP may be given orally. Doses are adjusted or treatment is changed to intravenous pentamidine if side effects are too severe. During the 21-day trial, zidovudine (AZT) may not be used because of possible increased bone marrow toxicity. AZT may be resumed as soon as the patient's white cell count is acceptable. Drug therapy aimed at preventing recurrence of PCP is not allowed for a minimum of 4 weeks after the completion of study therapy.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Prior Medication:
Allowed:
Exclusion Criteria
Patients with the following are excluded:
Prior Medication:
Excluded within 14 days of study entry:
United States, California | |||||
San Francisco AIDS Clinic / San Francisco Gen Hosp | |||||
San Francisco, California, United States, 941102859 | |||||
Univ of Southern California / LA County USC Med Ctr | |||||
Los Angeles, California, United States, 900331079 | |||||
Los Angeles County - USC Med Ctr | |||||
Los Angeles, California, United States, 90033 | |||||
Harbor UCLA Med Ctr | |||||
Torrance, California, United States, 90502 | |||||
United States, Illinois | |||||
Northwestern Univ Med School | |||||
Chicago, Illinois, United States, 60611 | |||||
United States, Indiana | |||||
Indiana Univ Hosp | |||||
Indianapolis, Indiana, United States, 462025250 | |||||
United States, Louisiana | |||||
Charity Hosp / Tulane Univ Med School | |||||
New Orleans, Louisiana, United States, 70112 | |||||
Tulane Univ School of Medicine | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, New York | |||||
SUNY - Stony Brook | |||||
Stony Brook, New York, United States, 117948153 | |||||
Mount Sinai Med Ctr | |||||
New York, New York, United States, 10029 | |||||
Jack Weiler Hosp / Bronx Municipal Hosp | |||||
Bronx, New York, United States, 10465 | |||||
Cornell Univ Med Ctr | |||||
New York, New York, United States, 10021 | |||||
Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |||||
Bronx, New York, United States, 10461 | |||||
Montefiore Med Ctr / Bronx Municipal Hosp | |||||
Bronx, New York, United States, 10467 | |||||
SUNY / Erie County Med Ctr at Buffalo | |||||
Buffalo, New York, United States, 14215 | |||||
Beth Israel Med Ctr / Peter Krueger Clinic | |||||
New York, New York, United States, 10003 | |||||
City Hosp Ctr at Elmhurst / Mount Sinai Hosp | |||||
Elmhurst, New York, United States, 11373 | |||||
United States, North Carolina | |||||
Univ of North Carolina | |||||
Chapel Hill, North Carolina, United States, 275997215 | |||||
United States, Ohio | |||||
Ohio State Univ Hosp Clinic | |||||
Columbus, Ohio, United States, 432101228 | |||||
Holmes Hosp / Univ of Cincinnati Med Ctr | |||||
Cincinnati, Ohio, United States, 452670405 | |||||
Univ Hosp of Cleveland / Case Western Reserve Univ | |||||
Cleveland, Ohio, United States, 44106 | |||||
United States, Pennsylvania | |||||
Milton S Hershey Med Ctr | |||||
Hershey, Pennsylvania, United States, 170330850 | |||||
United States, South Carolina | |||||
Julio Arroyo | |||||
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Sattler FR |
Click here for more information about Sulfamethoxazole-Trimethoprim 
  |
Study ID Numbers: | ACTG 031 |
First Received: | November 2, 1999 |
Last Updated: | July 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00001014 |
Health Authority: | United States: Federal Government |
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