Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumon… (NCT00000739) | Clinical Trial Compass
CompletedPhase 1
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
United States, Puerto Rico96 participants
Plain-language summary
Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children.
Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP ) breakthrough in children receiving two different dose regimens of dapsone.
Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established.
Who can participate
Age range
1 Month – 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
Concurrent Medication:
Allowed:
* Rifampin and rifampin derivatives for up to 1 week during the study.
* Rifabutin or other drugs that could alter dapsone metabolism (if prescribed by the child's primary care physician).
Patients must have:
* Evidence of HIV infection.
PER AMENDMENT 11/16/95:
* Children who require prophylaxis. (Was written - Risk of developing PCP.)
* Known intolerance to TMP / SMX.
* Consent of parent or guardian. Patients entering this study may be co-enrolled in other ACTG pediatric studies.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
* Glucose-6-phosphate dehydrogenase deficiency.
* Known allergy to dapsone.
Concurrent Medication:
Excluded:
* Rifampin, rifampin derivatives, or oxidant drugs for more than 1 week.
Patients with the following prior conditions are excluded:
* Serious or life-threatening reactions to TMP / SMX (e.g., anaphylaxis, Stevens-Johnson syndrome, hypotension) that would contraindicate therapy with sulfa drugs.
Prior Medication:
Excluded:
* Prior dapsone.
* Rifampin, rifampin derivatives, or oxidant drugs within 1 week prior to study entry.
* TMP / SMX within 7 days prior to study entry (and toxicity must be clearly resolving).
Prior Treatment:
Excluded:
* RBC transfusion within 4 weeks prior to study entry.
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 IDNCT00000739
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)