Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT00002120
Eligibility Criteria:
Inclusion Criteria
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.
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:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Study:
NCT00002120
Study Brief:
Protocol Section:
NCT00002120