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Clinical Trials/NCT00002120
NCT00002120CompletedPhase 1

Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis Carinii Pneumonia

U.S. Bioscience2 sites in 1 country20 target enrollmentStarted: August 31, 2001Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
20
Locations
2
Study OverviewStudy DesignEligibility CriteriaInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To evaluate the safety of the combination of trimetrexate glucuronate (TMTX) and dapsone with leucovorin protection versus trimethoprim/sulfamethoxazole (TMP/SMX) in patients with AIDS and moderately severe Pneumocystis carinii pneumonia (PCP). To determine the pharmacokinetic parameters of TMTX, leucovorin, and dapsone and of TMP/SMX when given to patients with AIDS and moderately severe PCP.

Study Design

Study Type
Interventional
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
13 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Concurrent Medication:
  • •Empiric therapy for other opportunistic pulmonary infection (TB or fungi) for the first 72 hours of study enrollment ONLY, until presence of suspected pathogens can be confidently excluded.
  • •Patients must have:
  • •Confirmed diagnosis of PCP.
  • •Alveolar-arterial differences in dissolved oxygen >= 35 mm Hg but < 55 mm Hg on room air.

Exclusion Criteria

  • •Co-existing Condition:
  • •Patients with the following symptoms or conditions are excluded:
  • •Severe renal or hepatic dysfunction.
  • •Serious or life-threatening intolerance to TMP/SMX, TMTX, or dapsone.
  • •Concurrent pneumothorax.
  • •Active pulmonary tuberculosis or other inadequately treated opportunistic pulmonary infection (e.g., Cryptococcus neoforms, CMV). NOTE:
  • •Identification of Mycobacterium avium or CMV in sputum or BAL fluid does not exclude, since these organisms may be present without causing disease.
  • •Pulmonary Kaposi's sarcoma.
  • •Active opportunistic infections or malignancies requiring induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy).
  • •Unable to have arterial blood gases on room air obtained at baseline.
  • •Unwilling to undergo bronchoscopy, if sputum induction does not reveal Pneumocystis carinii.
  • •Suspected malabsorption (e.g., ileus or severe diarrhea with > 6 stools/day).
  • •Known absence of G6PD activity.
  • •Large volume (1.0 to 1.5 liters) of intravenous fluid (5 percent in water) per 24 hours is medically inadvisable.
  • •Unwilling to comply with study design.
  • •Concurrent Medication:
  • •Induction therapy with bone marrow suppressive drugs (e.g., ganciclovir) or hepatotoxic drugs (e.g., chemotherapy).
  • •AZT, ddI, ddC, d4T, or other antiretroviral therapy.
  • •Patients with the following prior condition are excluded:
  • •Prior history of serious or life-threatening intolerance to TMP/SMX. (NOTE:
  • •Patients with less severe reactions may be included at the discretion of the investigator and primary care provider.)
  • •Prior Medication:
  • •More than 24 hours of systemic anti-PCP therapy within 2 weeks prior to study entry.

Investigators

Sponsor
U.S. Bioscience
Sponsor Class
Industry

Study Sites (2)

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