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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001013 |
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.
Condition | Intervention | Phase |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Trimetrexate glucuronate Drug: Pentamidine isethionate Drug: Sulfamethoxazole-Trimethoprim Drug: Leucovorin calcium |
Phase III |
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: | 364 |
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 than SMX/TMP in treating PCP and in preventing a recurrence of PCP. Preliminary studies suggest that aerosolized pentamidine (PEN) is likely to be effective in preventing a recurrence of PCP.
Patients entered in the study are randomly assigned to TMTX / LCV or to 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 PEN 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. Aerosolized PEN therapy is begun 7 - 10 days after completion of therapy for the acute episode. PEN is inhaled once weekly for 4 weeks, then every 2 weeks for 48 weeks.
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
Co-existing Condition:
Patients will be excluded for the following reasons:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 14 days of study entry:
United States, California | |
Los Angeles County - USC Med Ctr | |
Los Angeles, California, United States, 90033 | |
United States, District of Columbia | |
George Washington Univ Med Ctr | |
Washington, District of Columbia, United States, 20037 | |
United States, Florida | |
Univ of Miami School of Medicine | |
Miami, Florida, United States, 331361013 | |
United States, Illinois | |
Northwestern Univ Med School | |
Chicago, Illinois, United States, 60611 | |
United States, Louisiana | |
Charity Hosp / Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
Louisiana State Univ Med Ctr / Tulane Med School | |
New Orleans, Louisiana, United States, 70112 | |
Tulane Univ School of Medicine | |
New Orleans, Louisiana, United States, 70112 | |
United States, Massachusetts | |
Univ of Massachusetts Med Ctr | |
Worcester, Massachusetts, United States, 01655 | |
United States, New York | |
SUNY / State Univ of New York | |
Syracuse, New York, United States, 13210 | |
SUNY - Stony Brook | |
Stony Brook, New York, United States, 117948153 | |
Univ of Rochester Medical Center | |
Rochester, New York, United States, 14642 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
Jack Weiler Hosp / Bronx Municipal Hosp | |
Bronx, New York, United States, 10465 | |
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, Ohio | |
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 | |
Thomas Jefferson Med College | |
Philadelphia, Pennsylvania, United States, 19107 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Sattler FR |
Study ID Numbers: | ACTG 029 |
Study First Received: | November 2, 1999 |
Last Updated: | July 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00001013 |
Health Authority: | United States: Federal Government |
Trimethoprim-Sulfamethoxazole Combination Trimetrexate AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine Infusions, Intravenous Leucovorin |
Drug Therapy, Combination Folic Acid Antagonists Aerosols Acquired Immunodeficiency Syndrome Antiprotozoal Agents AIDS-Related Complex Sulfamethoxazole-Trimethoprim |
Opportunistic Infections Sexually Transmitted Diseases, Viral Trimethoprim Clotrimazole Miconazole Leucovorin Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis Mycoses Respiratory Tract Diseases Respiratory Tract Infections AIDS-Related Opportunistic Infections Pentamidine Retroviridae Infections Trimetrexate |
Lung Diseases, Fungal Sulfamethoxazole Pneumocystosis Acquired Immunodeficiency Syndrome Tioconazole AIDS-Related Complex Immunologic Deficiency Syndromes Virus Diseases Folic Acid Calcium, Dietary Pneumocystis Infections HIV Infections Lung Diseases Sexually Transmitted Diseases Pneumonia |
Antimetabolites Anti-Infective Agents Trypanocidal Agents Antiprotozoal Agents Slow Virus Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Infection Renal Agents Antimalarials Antiparasitic Agents |
Antifungal Agents Vitamins Therapeutic Uses Micronutrients RNA Virus Infections Vitamin B Complex Immune System Diseases Growth Substances Anti-Infective Agents, Urinary Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Lentivirus Infections |