A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS
Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001
Trial Information
Current as of May 11, 2025
Completed
Keywords
ClinConnect Summary
The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
Patients with confirmed PCP are randomized into one of three treatment groups. Group A receives SMX/TMP. Half of group A receives dapsone placebo (placebo is an inactive substance) daily plus trimethoprim placebo; the other half receives clindamycin placebo plus primaquine placebo. Group B is given dapsone plus trimethoprim. Half of group B receives SM...
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- Concurrent Medication:
- Allowed:
- • Erythropoietin.
- • Maintenance treatment with investigational triazoles (e.g., itraconazole).
- • Antiemetics for nausea/vomiting, antihistamines for rash/pruritus, antipyretics for systemic symptoms (fever, headache, etc.) should be used for treatment of symptoms.
- • Nonsteroidal antiinflammatory agents may be used for control of myalgias, headache, etc.
- Concurrent Treatment:
- Allowed:
- • Blood transfusions.
- Patients must have the following:
- • Pneumocystis carinii pneumonia.
- • HIV infection.
- • Willing and able to sign informed consent. Patients under 18 years of age may enter with consent of parent or guardian.
- Prior Medication:
- Allowed:
- • Up to 24 hours of treatment with sulfamethoxazole/trimethoprim (SMX/TMP), dapsone / trimethoprim, or clindamycin / primaquine, or one dose of pentamidine for this episode of Pneumocystis carinii pneumonia (PCP).
- • Prior PCP prophylaxis.
- Required:
- • Adjunctive prednisone therapy in patients with (A-a) DO2 of 35 - 45 torr receiving acute anti-PCP treatment.
- • Exclusion Criteria
- Co-existing Condition:
- Patients with the following conditions and diseases are excluded:
- • Positive screen for glucose-6-phosphate dehydrogenase deficiency.
- • Known NAD methemoglobin reductase deficiency and/or known hemoglobin M abnormality.
- Concurrent Medication:
- Excluded:
- • Zidovudine (AZT).
- • Ganciclovir.
- • GM-CSF or G-CSF. Rifampin.
- • Rifabutin.
- • Corticosteroids (in patients with baseline (A-a) DO2 \< 35 torr). Investigational drugs not specifically allowed.
- • Folinic acid.
- Patients with the following are excluded:
- • Previous dose-limiting intolerance to sulfones, trimethoprim, clindamycin, or primaquine.
- • Requirement for other medications potentially effective in the treatment of Pneumocystis carinii pneumonia (PCP) (e.g., pyrimethamine and sulfadiazine).
- • Prior enrollment in ACTG 108. Presence of other concurrent pulmonary pathology that would make interpretation of response to antipneumocystis therapy difficult.
- • Inability to take oral therapy.
- Prior Medication:
- Excluded:
- • Acute treatment doses of anti-Pneumocystis carinii pneumonia agents within 30 days prior to study entry except as noted above.
- • Systemic steroids above adrenal replacement doses within 7 days prior to study entry (except for patients with (A-a) DO2 of 35 - 45 torr who receive prednisone in conjunction with acute anti-PCP treatment).
About National Institute Of Allergy And Infectious Diseases (Niaid)
The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Palo Alto, California, United States
San Francisco, California, United States
San Jose, California, United States
San Mateo, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Saint Louis, Missouri, United States
Buffalo, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Seattle, Washington, United States
Pittsburgh, Pennsylvania, United States
Patients applied
Trial Officials
Safrin S
Study Chair
Black JR
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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