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

NCT00000722 | Completed

• 2 other identifiers: ACTG 04111016
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Pneumonia, Pneumocystis carinii; Pentamidine; Injections, Intravenous; Lung; Administration, Inhalation; Aerosols; Acquired Immunodeficiency Syndrome

Interventions

Pentamidine isethionate DRUG

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

SUNY - Stony Brook

Stony Brook, New York, 117948153, United States

Location

Related Publications (3)

• Smaldone GC, Fuhrer J, Steigbigel RT, McPeck M. Factors determining pulmonary deposition of aerosolized pentamidine in patients with human immunodeficiency virus infection. Am Rev Respir Dis. 1991 Apr;143(4 Pt 1):727-37. doi: 10.1164/ajrccm/143.4_Pt_1.727.

  PMID: 2008984 BACKGROUND

• Smaldone GC, Vinciguerra C, Morra L. Urine pentamidine as an indicator of lung pentamidine in patients receiving aerosol therapy. Chest. 1991 Nov;100(5):1219-23. doi: 10.1378/chest.100.5.1219.

  PMID: 1935274 BACKGROUND

• Montgomery AB, Feigal DW Jr, Sattler F, Mason GR, Catanzaro A, Edison R, Markowitz N, Johnson E, Ogawa S, Rovzar M, et al. Pentamidine aerosol versus trimethoprim-sulfamethoxazole for Pneumocystis carinii in acquired immune deficiency syndrome. Am J Respir Crit Care Med. 1995 Apr;151(4):1068-74. doi: 10.1164/ajrccm/151.4.1068.

  PMID: 7697233 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumocystis; HIV Infections; AIDS-Related Opportunistic Infections; Respiratory Aspiration; Acquired Immunodeficiency Syndrome

Interventions

Pentamidine

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Benzamidines; Amidines; Organic Chemicals

Study Officials

• Smaldone GC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: June 1, 1991
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (1)