NCT00002002

Brief Summary

The primary objective of the study is to evaluate the effectiveness of l-leucovorin in preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a therapy for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

July 1, 1992

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Pneumonia, Pneumocystis CariniiHIV Infections

Keywords

Trimethoprim-Sulfamethoxazole CombinationAIDS-Related Opportunistic InfectionsPneumonia, Pneumocystis cariniiAcquired Immunodeficiency Syndrome

Interventions

TrimethoprimDRUG
SulfamethoxazoleDRUG
Leucovorin calciumDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have the following:
  • Diagnosis of PCP.
  • Fit the CDC definition of AIDS.
  • Be receiving intravenous or oral trimethoprim / sulfamethoxazole (Bactrim, Septra) in doses of = or \> 15mg/kg/day of the trimethoprim component.
  • Be receiving = or \< 48 hours of trimethoprim / sulfamethoxazole (TMP / SMX) prior to randomization.
  • Must sign informed consent in accordance with FDA guidelines.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Cannot take oral medications.
  • Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.
  • Concurrent Medication:
  • Excluded:
  • Continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.
  • Patients with the following are excluded:
  • Cannot take oral medications.
  • Require continued administration of anticonvulsant agents such as phenytoin, phenobarbital or primidone.
  • Prior Medication:
  • Excluded:
  • \> 48 hours of trimethoprim / sulfamethoxazole prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Related Publications (1)

  • Safrin S, Lee BL, Sande MA. Adjunctive folinic acid with trimethoprim-sulfamethoxazole for Pneumocystis carinii pneumonia in AIDS patients is associated with an increased risk of therapeutic failure and death. J Infect Dis. 1994 Oct;170(4):912-7. doi: 10.1093/infdis/170.4.912.

    PMID: 7930736BACKGROUND

MeSH Terms

Conditions

Pneumonia, PneumocystisHIV InfectionsAIDS-Related Opportunistic InfectionsAcquired Immunodeficiency Syndrome

Interventions

TrimethoprimSulfamethoxazoleLeucovorin

Condition Hierarchy (Ancestors)

Lung Diseases, FungalMycosesBacterial Infections and MycosesInfectionsPneumocystis InfectionsRespiratory Tract InfectionsPneumoniaLung DiseasesRespiratory Tract DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesOpportunistic InfectionsSlow Virus Diseases

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1992-07

Locations

US(1)