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
2 other identifiers
interventional
290
1 country
32
Brief Summary
To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
September 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 3, 2021
October 1, 2021
November 2, 1999
October 26, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- +4 more criteria
You may not qualify if:
- 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).
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)lead
- Jacobus Pharmaceuticalcollaborator
- Glaxo Wellcomecollaborator
Study Sites (32)
USC CRS
Los Angeles, California, 90033, United States
Stanford CRS
Palo Alto, California, United States
Ucsf Aids Crs
San Francisco, California, United States
Santa Clara Valley Med. Ctr.
San Jose, California, United States
San Mateo County AIDS Program
San Mateo, California, United States
Harbor-UCLA Med. Ctr. CRS
Torrance, California, 90502, United States
University of Colorado Hospital CRS
Aurora, Colorado, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
Honolulu, Hawaii, 96816, United States
Rush Univ. Med. Ctr. ACTG CRS
Chicago, Illinois, 60612, United States
Northwestern University CRS
Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
Indianapolis, Indiana, 46202, United States
Methodist Hosp. of Indiana
Indianapolis, Indiana, 46202, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
New Orleans, Louisiana, 70112, United States
Johns Hopkins Adult AIDS CRS
Baltimore, Maryland, United States
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess - East Campus A0102 CRS
Boston, Massachusetts, 02215, United States
University of Minnesota, ACTU
Minneapolis, Minnesota, 55455, United States
Washington U CRS
St Louis, Missouri, United States
SUNY - Buffalo, Erie County Medical Ctr.
Buffalo, New York, 14215, United States
Beth Israel Med. Ctr. (Mt. Sinai)
New York, New York, 10003, United States
NY Univ. HIV/AIDS CRS
New York, New York, 10016, United States
Cornell University A2201
New York, New York, 10021, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, 14642, United States
Unc Aids Crs
Chapel Hill, North Carolina, 27599, United States
Carolinas HealthCare System, Carolinas Med. Ctr.
Charlotte, North Carolina, 28203, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
Greensboro, North Carolina, United States
Univ. of Cincinnati CRS
Cincinnati, Ohio, United States
Case CRS
Cleveland, Ohio, 44106, United States
The Ohio State Univ. AIDS CRS
Columbus, Ohio, 43210, United States
Pitt CRS
Pittsburgh, Pennsylvania, 15213, United States
University of Washington AIDS CRS
Seattle, Washington, United States
Related Publications (3)
Wu AW, Gray S, Brookmeyer R, Safrin S. Quality of life in a double-blind randomized trial of 3 oral regimens for mild-to-moderate Pneumocystis carinii pneumonia in AIDS (ACTG 108). Int Conf AIDS. 1996 Jul 7-12;11(1):229 (abstract no TuB112)
BACKGROUNDSafrin S, Finkelstein DM, Feinberg J, Frame P, Simpson G, Wu A, Cheung T, Soeiro R, Hojczyk P, Black JR. Comparison of three regimens for treatment of mild to moderate Pneumocystis carinii pneumonia in patients with AIDS. A double-blind, randomized, trial of oral trimethoprim-sulfamethoxazole, dapsone-trimethoprim, and clindamycin-primaquine. ACTG 108 Study Group. Ann Intern Med. 1996 May 1;124(9):792-802. doi: 10.7326/0003-4819-124-9-199605010-00003.
PMID: 8610948BACKGROUNDRubin HR, Wu AW, Gutierrez M, Liriano O, Safrin S. Spanish translation of a functional status questionnaire for Pneumocystis carinii pneumonia. Int Conf AIDS. 1992 Jul 19-24;8(2):B178 (abstract no PoB 3549)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Safrin S
- STUDY CHAIR
Black JR
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
September 1, 1994
Last Updated
November 3, 2021
Record last verified: 2021-10