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An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies Clinical research trials and An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies. An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies clinical trial. Test subjects typically obtain the finest healthcare available for their An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies  An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies
An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the safety and effectiveness of an investigational drug therapy (trimetrexate plus leucovorin calcium (TMTX / LCV)) in the treatment of Pneumocystis carinii pneumonia (PCP) in patients who have AIDS, are HIV positive, or are at high risk for HIV infection, and who have suffered severe or life-threatening ill effects from both conventional therapies for PCP. AMENDED: 08/01/90 As of August 31, 1989, 437 patients were enrolled into uncontrolled studies of trimetrexate for PCP:214 in TX 301/ACTG 0=039 (trimetrexate for patients intolerant of approved therapies) and 223 in NS 401 (trimetrexate for patients refractory to approved therapies). The analysis of overall response rate, stringently defined as having received at least 14 days of trimetrexate and being alive at follow-up 1 month after the completion of therapy, reveals 84/159 intolerant patients and 48/160 refractory patients had responded, for rates of 53 percent and 30 percent, respectively. These response rates include all individuals who received at least one dose of trimetrexate. Of the 111 patients who were ventilator-dependent at study entry, 18 completed a course of therapy and were alive a month later, for a response rate of 16 percent. All other ventilated patients died. The most common severe (grades 3 and 4) toxicities were: transaminase elevation (> 5 x normal) in 94 patients, anemia (< 7.9 g/dl) in 109, neutropenia (< 750 cells/mm3) in 58, fever (> 40 C) in 37, and thrombocytopenia (< 50000 platelets/mm3) in 27. Toxicity required discontinuation of therapy in approximately 5 percent of all patients. Original design: The drugs usually used to treat PCP in AIDS patients, trimethoprim / sulfamethoxazole and pentamidine, have had to be discontinued in many patients because of severe side effects. Currently there are no proven alternatives to these drugs. TMTX was chosen for this trial because it was found to be very active against the PCP organism in laboratory tests. Also TMTX, in combination with LCV, had a high response rate and did not cause severe toxicity in a preliminary trial.
Details: AMENDED: 08/01/90 As of August 31, 1989, 437 patients were enrolled into uncontrolled studies of trimetrexate for PCP:214 in TX 301/ACTG 0=039 (trimetrexate for patients intolerant of approved therapies) and 223 in NS 401 (trimetrexate for patients refractory to approved therapies). The analysis of overall response rate, stringently defined as having received at least 14 days of trimetrexate and being alive at follow-up 1 month after the completion of therapy, reveals 84/159 intolerant patients and 48/160 refractory patients had responded, for rates of 53 percent and 30 percent, respectively. These response rates include all individuals who received at least one dose of trimetrexate. Of the 111 patients who were ventilator-dependent at study entry, 18 completed a course of therapy and were alive a month later, for a response rate of 16 percent. All other ventilated patients died. The most common severe (grades 3 and 4) toxicities were: transaminase elevation (> 5 x normal) in 94 patients, anemia (< 7.9 g/dl) in 109, neutropenia (< 750 cells/mm3) in 58, fever (> 40 C) in 37, and thrombocytopenia (< 50000 platelets/mm3) in 27. Toxicity required discontinuation of therapy in approximately 5 percent of all patients. Original design: The drugs usually used to treat PCP in AIDS patients, trimethoprim / sulfamethoxazole and pentamidine, have had to be discontinued in many patients because of severe side effects. Currently there are no proven alternatives to these drugs. TMTX was chosen for this trial because it was found to be very active against the PCP organism in laboratory tests. Also TMTX, in combination with LCV, had a high response rate and did not cause severe toxicity in a preliminary trial. Patients entered in the study are given TMTX for 21 days and LCV for 24 days. Doses are determined by body size. Both drugs are given by intravenous infusion, but LCV may be given orally after the first 10 days. It is essential to ensure that patients receive each and every dose of LCV and that LCV therapy is continued for a full 3 days after TMTX therapy has been completed or discontinued. Doses are adjusted if side effects, such as low white blood cell counts, 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 administration of TMTX and LCV has been completed.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Noninvestigational therapies as needed. - Maintenance therapy with investigational triazoles such as itraconazole and SCH 39304. - High-dose corticosteroids (exceed physiologic replacement doses) including oral prednisone 40 mg bid for 5 days, 40 mg daily for 5 days and then 20 mg daily for the remainder of PCP therapy. Same dose for methylprednisolone. Concurrent Treatment: Allowed: - Any ventilatory support, antihypertensive agents, invasive monitoring, and other necessary medical intervention, according to his/her medical status, personal wishes, and the judgment of his/her physician. Patients must have: - HIV seropositivity. - Diagnosis of Pneumocystis carinii pneumonia (PCP). - Serious intolerance to trimethoprim / sulfamethoxazole (TMP / SMX) therapy defined as follows: - Platelets < 50000 platelets/mm3. - Neutrophil count (polys plus bands) = or < 500 cells/mm3 on at least two occasions = or > 12 hours apart. - Mucocutaneous reaction - blistering rash, mucosal involvement, generalized maculopapular eruption, or intolerable pruritus. - Hepatitis demonstrated by transaminase elevation > 5 times the upper limit of normal, or = or > 300 IU if baseline is abnormal. - Drug fever with daily temperature = or > 103 degrees F beginning after the 5th day of treatment persisting for at least 3 days and not responsive to antipyretic therapy, with no other discernible cause. - Any other severe or life-threatening adverse reaction to TMP / SMX which, in the investigator's opinion, makes continued or recurrent treatment with TMP / SMX inadvisable as determined on a case-by-case basis. - Serious intolerance to pentamidine therapy defined as follows: - Platelets < 50000 platelets/mm3. - Neutrophil count (polys plus bands) = or < 500 cells/mm3 on at least two occasions = or > 12 hours apart. - Serum creatinine > 3.0 mg/dl. - Systolic blood pressure < 90 mm requiring supportive therapy. - Symptomatic hypoglycemia with blood glucose < 40, or hyperglycemia requiring therapy. - Pancreatitis with laboratory confirmation (abnormal amylase and/or lipase). - Any other severe or life-threatening adverse reaction to pentamidine, which, in the investigator's opinion, makes continued or recurrent treatment with pentamidine inadvisable as determined on a case-by-case basis. - Informed consent by patient or legal guardian. Prior Medication: Required: - Trimethoprim / sulfamethoxazole and pentamidine therapies. Prior Medication: Allowed: - Myelosuppressive or nephrotoxic agents including zidovudine. History of high-risk behavior for HIV infection - homosexual or bisexual men, intravenous drug abusers, recipients of HIV-infected blood products, or sexual partners of persons in these groups may be admitted without proof of HIV infection. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate. - Patients with a less severe adverse reaction may be enrolled if, in the opinion of the investigator, these adverse effects do not prohibit rechallenge with the drug. Concurrent Medication: Excluded: - Myelosuppressive or nephrotoxic agents including zidovudine and ganciclovir. - Investigational therapies. Patients with the following are excluded: - History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate. - Patients with a less severe adverse reaction may be enrolled if, in the opinion of the investigator, these adverse effects do not prohibit rechallenge with the drug.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FeinbergJ, Study Chair,
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Beth Israel Med Ctr
New York City, New York, 10003
United States
Univ of Washington
Seattle, Washington, 981224304
United States
Univ of Miami School of Medicine
Miami, Florida, 331361013
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Warner-Lambert Parke-Davis
Morris Plains, New Jersey, 07950
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Beth Israel Deaconess - West Campus
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: ACTG 039;
Study Start Date:
Record last reviewed: August 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000714
Other Pneumonia, Pneumocystis Carinii Studies:
1. A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis carinii Pneumonia in AIDS
2. Phase I Safety and Pharmacokinetics Study of Microparticulate Atovaquone (m-Atovaquone; 566C80) in HIV-Infected and Perinatally Exposed Infants and Children.
3. Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis carinii Pneumonia Prophylaxis
4. A Study of Trimetrexate Plus Leucovorin in Children with Pneumocystis Carinii Pneumonia
5. Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
Related Studies:
Other Pneumonia, Pneumocystis carinii Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies
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