Aerosols in the Treatment of Pneumocystis Pneumonia: A Pilot Study Quantitating the Deposition of Aerosolized Pentamidine as Delivered in ACTG 040 and Comparing Its Toxicity With Parenteral Pentamidine Therapy
Completed · Not applicable
Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections
In brief
To compare the use of pentamidine aerosol (inhaled mist) with the standard intravenous method of administration in patients with AIDS related Pneumocystis carinii pneumonia (PCP), to measure the amount of pentamidine aerosol that actually reaches the lung, and to see if close clinical observation is safer and as effective as drug therapy in the prevention of PCP recurrences. To compare the efficiency of 2 nebulizers - the Respirgard II nebulizer and the Cadema Aerotech II nebulizer. Aerosolized pentamidine was as effective as intravenous pentamidine in treating PCP in animals. More of the pentamidine reached the lungs and less was found in the liver and kidney after pentamidine was given by aerosol than after an intravenous injection. This suggests that the toxicity of pentamidine may be less if given by aerosol than if given by the intravenous route.
Key facts
- Study ID
- NCT00000722
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 45
- Expected to finish
- 1991-06-01
- Last updated by the study team
- 2021-11-03
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Prior Medication:
- Allowed:
- Prophylaxis for Pneumocystis carinii pneumonia (PCP); zidovudine.
- Unequivocal diagnosis of Pneumocystis carinii pneumonia (PCP) established by morphological confirmation of three or more typical Pneumocystis carinii organisms in bronchoalveolar lavage fluid, obtained immediately following the initial inhalation of radiolabeled aerosol.
- Resting (A-a) DO2 < 30 torr on room air or resting (A-a) DO2 = or < 55 torr on room air with a serious intolerance to trimethoprim / sulfamethoxazole (TMP / SMX), defined as one or more of the following:
- Platelets < 50000 platelets/mm3 or absolute neutrophil count (polys plus bands) = or < 500 cells/mm3 on at least two occasions = or > 12 hours apart.
- Blistering rash, mucosal involvement, generalized maculopapular eruption, or intolerable pruritus.
- Transaminase > 5 x ULN or = or > 300 IU if baseline is abnormal.
- Daily temperature = or > 103 degrees F beginning after the 5th day of treatment and persisting for at least 3 days and not responsive to antipyretic therapy, with no other discernible cause.
- Any other severe or life-threatening adverse reaction to TMP / SMX that, in the investigator's opinion, makes continued or recurrent treatment with TMP / SMX inadvisable (approved on a case-by-case basis by the NIAID clinical monitor).
You may not qualify if…
- Co-existing Condition:
- Patients with the following conditions or diseases are excluded:
- Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration.
- History of major adverse reaction to pentamidine.
- Patients with the following conditions or diseases are excluded:
- Dyspnea, cough, bronchospasm, or other reasons causing inability to cooperate with aerosol administration.
- History of major adverse reaction to pentamidine.
- Prior Medication:
- Excluded:
- Other antiprotozoal regimens.
- Excluded within 14 days of entry:
- Systemic steroids > adrenal replacement doses
Where it is running
- SUNY - Stony Brook — Stony Brook, New York, United States
Full record on ClinicalTrials.gov
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