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Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Clinical research trials and Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS. Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS clinical trial. Subjects often receive the most expert healthcare possible for their Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS  Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Acetaminophen 650 mg prescribed as necessary for temperature > 38.7 degrees C. Acetaminophen q4h should not be prescribed as a standing order for more than 48 hours. Prior Medication: Allowed: - Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed. - Prophylaxis for Pneumocystis carinii pneumonia (PCP). - Unequivocal diagnosis of Pneumocystis carinii pneumonia (PCP) by morphologic confirmation of three or more typical P. carinii organisms in sputum, bronchoalveolar lavage fluid, or lung tissue obtained by transbronchial or open-lung biopsy within 3 days before or after randomization. If morphologic confirmation is not possible prior to therapy, patients may be randomized if the investigator believes there is a high suspicion of PCP based on clinical presentation. If morphologic diagnosis cannot be established within 6 days of randomization, the patient will be withdrawn from study therapy. - Resting alveolar-arterial oxygen differences = or > 30 mm Hg on room air. Exclusion Criteria Patients with the following are excluded: - Inability to have alveolar blood gas analysis on room air. - Medically unable to receive a liter of intravenous fluid (5 percent dextrose in water) per 24 hours. This procedure is required in order to maintain blinding. Prior Medication: Excluded within 14 days of study entry: - Systemic steroids exceeding physiological replacement. - Other investigational drugs. - Excluded within 6 weeks of study entry: - Antiprotozoal regimen for this episode consisting of pentamidine, eflornithine, DFMO, or dapsone, for therapy of active Pneumocystis carinii pneumonia (PCP) - History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reaction secondary to antibiotics containing sulfa, trimethoprim, or trimetrexate. - History of life-threatening pentamidine toxicity. - Requirement for treatment with agents that are known to be myelosuppressive or nephrotoxic during the period of acute Pneumocystis carinii pneumonia (PCP) therapy. - Other drugs for the treatment or prevention of AIDS or Pneumocystis carinii pneumonia (PCP); disulcid; aspirin; acetaminophen q4h for more than 48 hours.
Total Enrollment: 302
Location and Contact Information:
Overall Study Official:
SattlerFR, Study Chair,
Montefiore Med Ctr / Bronx Municipal Hosp
Bronx, New York, 10467
United States
Beth Israel Med Ctr / Peter Krueger Clinic
New York City, New York, 10003
United States
Harbor UCLA Med Ctr
Torrance, California, 90502
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Julio Arroyo
West Columbia, South Carolina, 29169
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859
United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112
United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
Elmhurst, New York, 11373
United States
Milton S Hershey Med Ctr
Hershey, Pennsylvania, 170330850
United States
Jack Weiler Hosp / Bronx Municipal Hosp
Bronx, New York, 10465
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
United States
SUNY - Stony Brook
Stony Brook, New York, 117948153
United States
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Charity Hosp / Tulane Univ Med School
New Orleans, Louisiana, 70112
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Holmes Hosp / Univ of Cincinnati Med Ctr
Cincinnati, Ohio, 452670405
United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106
United States
Additional Information:
Study ID Numbers: ACTG 031;
Study Start Date:
Record last reviewed: March 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001014
Other Hiv Infections Studies:
1. A Phase I Multicenter, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of Recombinant Vaccinia Virus Expressing the Envelope Glycoproteins of Human Immunodeficiency Virus
2. A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 1592U89
3. A Study to Compare the Effectiveness of a Four Drug Anti-HIV Regimen Given Alone or in Combination with GM-CSF or IL-12 to HIV-Positive Patients
4. Treating Genital Herpes to Decrease Risk of HIV Acquisition
5. Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
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Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
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