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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00001003 |
To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with advanced HIV disease and T4 cell count < 200 cells/mm3. To establish the range of pentamidine (PEN) deposition in AIDS patients participating in ACTG 021 and ACTG 081. To identify factors (breathing pattern, pulmonary function) that may be important in affecting the actual dose delivered to a given patient.
The specific system that is used to deliver PEN to the lungs may determine whether a therapeutically effective dose is attained in the lungs. Therefore, this study will establish the amount of PEN that is deposited in the lungs of patients enrolled in protocols ACTG 021 and ACTG 081, who are being treated with PEN administered from the Marquest Respirgard II nebulizer.
Condition | Intervention |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Pentamidine isethionate Drug: Zidovudine |
Study Type: | Interventional |
Study Design: | Treatment, Placebo Control, Pharmacokinetics Study |
Official Title: | Aerosols in the Treatment of Pneumocystis Carinii Pneumonia: A Nested Study Quantitating the Delivery of Aerosolized Pentamidine for Prophylaxis of PCP in Protocols ACTG 021 and ACTG 081 |
Estimated Enrollment: | 20 |
The specific system that is used to deliver PEN to the lungs may determine whether a therapeutically effective dose is attained in the lungs. Therefore, this study will establish the amount of PEN that is deposited in the lungs of patients enrolled in protocols ACTG 021 and ACTG 081, who are being treated with PEN administered from the Marquest Respirgard II nebulizer.
Approximately 4 weeks after patients in ACTG 021 and ACTG 081 have begun PEN aerosol therapy for the prevention of PCP, patients undergo the first radioactive aerosol study. The patient inhales a mist while sitting with his/her back against a gamma camera. The resulting picture outlines the lungs. This mist contains a single dose of PEN mixed with a small amount of radioactivity (99m-technetium ertechnetate). The gamma camera determines where the particles deposit in the lungs. The radioactivity exposure is equivalent to a typical xray of the ribs. This procedure takes about 45 minutes; 6 hours later another 30-minute gamma camera image is obtained. Blood is withdrawn to measure the blood level of PEN as done in ACTG 021 and ACTG 081. The entire procedure is repeated near the end of the prophylactic schedule (about 10-12 months after the start of aerosol PEN treatments).
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Treatment:
Allowed:
Patients who successfully completed a course of study therapy for acute Pneumocystis carinii pneumonia (PCP) and who met the inclusion criteria for Protocol ACTG 021 or ACTG 081 and were randomized to the aerosolized pentamidine arm.
Exclusion Criteria
The following patients are excluded:
Prior Treatment:
Excluded within 2 weeks of study entry:
Co-Existing Condition:
Active substance abuse.
Study ID Numbers: | ACTG 079 |
Study First Received: | November 2, 1999 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00001003 |
Health Authority: | United States: Federal Government |
AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine Nebulizers and Vaporizers |
Lung Administration, Inhalation Acquired Immunodeficiency Syndrome Zidovudine |
Opportunistic Infections Sexually Transmitted Diseases, Viral Clotrimazole Pneumocystosis Miconazole Acquired Immunodeficiency Syndrome Tioconazole Zidovudine Immunologic Deficiency Syndromes Virus Diseases Mycoses Pneumonia, Pneumocystis |
Pneumocystis Infections Respiratory Tract Infections Respiratory Tract Diseases HIV Infections Lung Diseases AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Pentamidine Retroviridae Infections Pneumonia Lung Diseases, Fungal |
Antimetabolites Anti-Infective Agents Trypanocidal Agents RNA Virus Infections Antiprotozoal Agents Anti-HIV Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Antiparasitic Agents Anti-Retroviral Agents Antifungal Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |