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Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients

NCT00000730 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2021-11-03

No results posted yet for this study

Summary

This study compares three different therapies for treatment of refractory Pneumocystis carinii pneumonia (PCP) in patients with AIDS. "Refractory" means that the patient has failed to respond to at least 4 days of treatment with either of two standard therapies: (1) sulfamethoxazole/trimethoprim (SMX/TMP) or (2) pentamidine (PEN). This study compares therapy with trimetrexate (TMTX) and leucovorin (LCV) to standard therapy and standard therapy plus high-dose steroids (methylprednisolone). The purpose is to find better and safer forms of treatment for PCP in AIDS patients. There is at present no scientific information about the best treatment for an AIDS patient with PCP who is not improving while receiving the standard therapies (SMX/TMP or PEN). New drug treatments are available, including steroid therapy and TMTX, but there is no information proving that these new treatments work better than the standard therapies.

Conditions

  • Pneumonia, Pneumocystis Carinii
  • HIV Infections

Interventions

DRUG

Trimetrexate glucuronate

DRUG

Methylprednisolone

DRUG

Pentamidine isethionate

DRUG

Sulfamethoxazole-Trimethoprim

DRUG

Leucovorin calcium

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Masur H

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
1989-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00000730 on ClinicalTrials.gov