A Study of Neutrexin Plus Leucovorin in the Treatment of Pneumocystis Carinii Pneumonia (PCP)
This study has been completed.
Sponsor:
U.S. Bioscience
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002434
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1994
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Purpose
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening toxicities to standard therapies (e.g., TMP/SMX or parenteral pentamidine).
| Condition | Intervention |
|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Trimetrexate glucuronate Drug: Leucovorin calcium |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for Patients With Pneumocystis Carinii Pneumonia |
Resource links provided by NLM:
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 2 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Myelosuppressive or nephrotoxic agents at the discretion of the treating physician.
Patients must have:
- Pneumocystis carinii pneumonia (PCP) confirmed within 15 days prior to study entry.
- Serious intolerance and/or resistance to standard therapies (such as trimethoprim/sulfamethoxazole and parenteral pentamidine) during the course of therapy for the current episode of PCP, or a documented history of such intolerance during a prior episode.
- Consent of parent or guardian if less than 18 years of age.
NOTE:
- Pregnant women may enroll after the physician and patient have discussed the potential benefit versus risk.
Exclusion Criteria
Patients with the following prior conditions are excluded:
History of Type I hypersensitivity (i.e., urticaria, angioedema, or anaphylaxis), exfoliative dermatitis, or other life-threatening reactions due to trimetrexate glucuronate.
Contacts and Locations More Information
Publications:
Feinberg J, McDermott C, Nutter J. Trimetrexate (TMTX) salvage therapy for PCP in AIDS patients with limited therapeutic options. Int Conf AIDS. 1992 Jul 19-24;8(2):B136 (abstract no PoB 3297)
| ClinicalTrials.gov Identifier: | NCT00002434 History of Changes |
| Other Study ID Numbers: | 132A, TMTX 0014 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Trimetrexate Pneumonia, Pneumocystis carinii Leucovorin Drug Therapy, Combination Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Leucovorin Levoleucovorin Trimetrexate Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Antidotes Protective Agents |
ClinicalTrials.gov processed this record on March 14, 2013
