A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine fo… (NCT00000727) | Clinical Trial Compass
CompletedPhase 3
A Controlled Comparative Trial of Sulfamethoxazole-Trimethoprim Versus Aerosolized Pentamidine for Secondary Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients Receiving Azidothymidine (AZT)
United States322 participants
Plain-language summary
To determine if the drug combination sulfamethoxazole-trimethoprim (SMX-TMP), given by mouth, and the drug pentamidine (PEN), given by inhaled aerosol, are effective in preventing a relapse of Pneumocystis carinii pneumonia (PCP) when they are given to patients who have recovered from a first episode of PCP and are being given zidovudine (AZT) to treat primary HIV infection.
AZT prolongs survival in patients with AIDS and decreases the occurrence of opportunistic infections such as PCP. However, PCP recurs in about 43 percent of patients receiving AZT, indicating a need for other treatments to reduce the relapse rate.
The two medications to be tested in this study, SMX/TMP and aerosolized PEN, have also been partially effective in preventing recurrence of PCP. It is hoped that the combination of AZT with these medications will be more effective than AZT or one of the medications alone.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
Patients must fulfill the following criteria:
* Randomization within 10 weeks of completing therapy for Pneumocystis carinii pneumonia (PCP).
* Ability to tolerate oral and aerosolized therapy at the time of randomization.
* Life expectancy \> 4 months.
Concurrent Medication:
Allowed:
* Inhaled bronchodilators for cough and bronchospasm related to aerosolized pentamidine treatment.
* Aspirin at modest doses.
* Ibuprofen at modest doses.
* Acetaminophen at modest doses.
* Erythropoietin for management of anemia.
* Allowed to treat opportunistic infections while on study:
* Acyclovir.
* Ketoconazole.
* Amphotericin B.
* Nystatin.
* Clotrimazole.
* Also allowed:
* Ganciclovir (DHPG) for maintenance therapy of life-threatening or sight-threatening cytomegalovirus retinitis (CMV retinitis) infection only.
* Zidovudine (AZT) must be discontinued during the acute induction phase of treatment and will be restarted when maintenance therapy is introduced.
Concurrent Treatment:
Allowed:
* Local radiation therapy for Kaposi's sarcoma.
Prior Medication:
Allowed:
* Primary prophylactic therapy prior to Pneumocystis carinii pneumonia (PCP) episode.
Risk Behavior:
Allowed:
* Patients maintained in a methadone maintenance program per local investigator's judgment.
Exclusion Criteria
* Active drug or alcohol abuse which would impair performance as a study subject.
Concurrent Medication:
Excluded:
* Famotidine.
* Any medications suspected of interference wi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00000727
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)