Pneumonia, Pneumocystis CariniiPhase 1NCT00002120
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
A Phase 1 study testing Trimetrexate glucuronate, Trimethoprim and Sulfamethoxazole in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by U.S. Bioscience at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Pneumonia, Pneumocystis Carinii, HIV Infections
- What is being tested?
- Trimetrexate glucuronate, Trimethoprim and Sulfamethoxazole
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- 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:
- AIDS.
- Confirmed diagnosis of PCP.
- Alveolar-arterial differences in dissolved oxygen >= 35 mm Hg but < 55 mm Hg on room air.
Who cannot join
- 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:
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- 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:
- Excluded:
- 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:
- Excluded:
- More than 24 hours of systemic anti-PCP therapy within 2 weeks prior to study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, 90033
About this study
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.
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Being tested
- Trimetrexate glucuronate, Trimethoprim, Sulfamethoxazole, Dapsone, Leucovorin calcium
- Keywords
- Trimethoprim-Sulfamethoxazole Combination, Trimetrexate, Pneumonia, Pneumocystis carinii, Leucovorin, Dapsone, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Pneumonia, Pneumocystis, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimetrexate glucuronateDrug
TrimethoprimDrug
SulfamethoxazoleDrug
DapsoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Pneumocystis CariniiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- U.S. Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jacobus Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002120
- Sponsor's protocol ID
- 224A
- Other IDs
- TMTX A009
- Status last verified
- Mar 1996
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00002120
- Acronym / sponsor ID
- 224A
- Conditions
- Pneumonia, Pneumocystis Carinii, HIV Infections
- Keywords
- Trimethoprim-Sulfamethoxazole Combination, Trimetrexate, Pneumonia, Pneumocystis carinii, Leucovorin, Dapsone, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- U.S. BioscienceIndustry (pharma, biotech, devices)
- Collaborators
- Jacobus Pharmaceutical
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- AIDS.
- Confirmed diagnosis of PCP.
- Alveolar-arterial differences in dissolved oxygen >= 35 mm Hg but < 55 mm Hg on room air.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimetrexate glucuronate | Drug | – |
| Trimethoprim | Drug | – |
| Sulfamethoxazole | Drug | – |
| Dapsone | Drug | – |
| Leucovorin calcium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trimetrexate glucuronate, Trimethoprim and Sulfamethoxazole in people with Pneumonia, Pneumocystis Carinii and HIV Infections, run by U.S. Bioscience at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.