A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS
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This is a randomized double-blinded controlled study comparing aerosolized pentamidine with trimethoprim plus sulfamethoxazole (TMP / PurposeX). The latter drug will be administered intravenously for at least 5 days, then changed to oral administration if warranted by the patient's clinical condition.
Condition | Intervention |
---|---|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Pentamidine isethionate |
Study Type: | Interventional |
Study Design: | Masking: Double-Blind Primary Purpose: Treatment |
Official Title: | A Controlled Trial Comparing the Efficacy of Aerosolized Pentamidine and Parenteral / Oral Trimethoprim - Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia in AIDS |
![](https://webarchive.library.unt.edu/web/20130315205824im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.
Pneumocystis carinii pneumonia (PCP) in an adult who is HIV positive by ELISA, HIV culture, or p24 antigenemia, or is a member of a risk group for HIV infection (homosexual or bisexual men, intravenous drug abusers, recipients of HIV infected blood products, and the sexual partners of the foregoing groups).
- The patient must have a resting Alveolar - arterial oxygen (A-a) DO2 less than 30 mmHg on room air at all ACTG sites, except San Francisco General Hospital. Other sites will enter patients up to a resting (A-a) DO2 = or < 55 mmHg on room air.
Prior Medication:
Allowed:
- Zidovudine as long as such therapy is suspended prior to randomization and not reinstituted until therapy for the acute episode is completed.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Dyspnea.
- Cough.
- Bronchospasm.
- History of a major adverse reaction to pentamidine or sulfonamide containing preparations.
Patients with the following will be excluded:
- Inability to cooperate with aerosol administration because of dyspnea, cough, bronchospasm, or other reasons.
- History of a major adverse reaction to pentamidine or sulfonamide containing preparations.
- In the opinion of the investigator, the patient would not complete therapy or follow-up for social reasons.
Prior Medication:
Excluded within 14 days of study entry:
- Systemic steroids above adrenal replacement doses.
- Excluded within 6 weeks of study entry:
- Other antiprotozoal regimen for this episode such as trimethoprim / sulfamethoxazole (TMP / PurposeX).
- Pyrimethamine.
- Fansidar.
- Pentamidine.
- Eflornithine (DFMO).
- Dapsone, whether therapeutic or prophylactic, or any of these agents.
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Publications:
ClinicalTrials.gov Identifier: | NCT00002056 History of Changes |
Other Study ID Numbers: | 023A, 87-001 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
Trimethoprim-Sulfamethoxazole Combination AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine |
Injections, Intravenous Administration, Oral Aerosols Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Pentamidine Trimethoprim Trimethoprim-Sulfamethoxazole Combination Sulfamethoxazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Antiparasitic Agents Trypanocidal Agents |
ClinicalTrials.gov processed this record on March 14, 2013