- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000816
Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis
Gradual Initiation of Trimethoprim/Sulfamethoxazole as Primary Pneumocystis Carinii Pneumonia Prophylaxis
To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients.
Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred.
Patients are randomized to receive either gradually increasing doses of SMX/TMP suspension or routine daily initiation of SMX/TMP double strength (DS) tablets for 2 weeks. All patients will then be switched over to receive open-label SMX/TMP DS tablets daily for 10 weeks.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00936
- San Juan City Hosp. PR NICHD CRS
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Mbeya, Tanzania
- Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
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California
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Los Angeles, California, United States, 90033
- USC CRS
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Palo Alto, California, United States, 94305
- Stanford CRS
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San Francisco, California, United States, 94110
- Ucsf Aids Crs
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San Jose, California, United States
- Santa Clara Valley Med. Ctr.
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San Mateo, California, United States
- San Mateo County AIDS Program
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Torrance, California, United States, 90502
- Harbor-UCLA Med. Ctr. CRS
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Colorado
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Aurora, Colorado, United States, 80262
- University of Colorado Hospital CRS
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Florida
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Jacksonville, Florida, United States, 32209
- Univ. of Florida Jacksonville NICHD CRS
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Miami, Florida, United States, 33136
- Univ. of Miami AIDS CRS
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Hawaii
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Honolulu, Hawaii, United States, 96816
- Univ. of Hawaii at Manoa, Leahi Hosp.
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Honolulu, Hawaii, United States, 96816
- Queens Med. Ctr.
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Illinois
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Chicago, Illinois, United States, 60612
- Cook County Hosp. CORE Ctr.
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Chicago, Illinois, United States, 60611
- Northwestern University CRS
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Chicago, Illinois, United States, 60612
- Rush Univ. Med. Ctr. ACTG CRS
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic
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Indianapolis, Indiana, United States, 46202
- Methodist Hosp. of Indiana
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Tulane/LSU Maternal/Child CRS
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Adult AIDS CRS
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital ACTG CRS
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Boston, Massachusetts, United States, 02118
- Bmc Actg Crs
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess Med. Ctr., ACTG CRS
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Boston, Massachusetts, United States, 02215
- Beth Israel Deaconess - East Campus A0102 CRS
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota, ACTU
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Minneapolis, Minnesota, United States, 55415
- Hennepin County Med. Ctr., Div. of Infectious Diseases
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Missouri
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Saint Louis, Missouri, United States
- Washington U CRS
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Saint Louis, Missouri, United States, 63112
- St. Louis ConnectCare, Infectious Diseases Clinic
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Nebraska
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Omaha, Nebraska, United States, 68198
- Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
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New York
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Buffalo, New York, United States, 14215
- SUNY - Buffalo, Erie County Medical Ctr.
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New York, New York, United States, 10016
- NY Univ. HIV/AIDS CRS
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New York, New York, United States, 10029
- Beth Israel Med. Ctr. (Mt. Sinai)
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Rochester, New York, United States
- Univ. of Rochester ACTG CRS
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Unc Aids Crs
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Charlotte, North Carolina, United States, 28203
- Carolinas HealthCare System, Carolinas Med. Ctr.
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Greensboro, North Carolina, United States, 27401
- Regional Center for Infectious Disease, Wendover Medical Center CRS
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Ohio
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Cincinnati, Ohio, United States, 45267
- Univ. of Cincinnati CRS
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Cleveland, Ohio, United States
- Case CRS
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Cleveland, Ohio, United States, 44109
- MetroHealth CRS
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Columbus, Ohio, United States, 43210
- The Ohio State Univ. AIDS CRS
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hosp. of the Univ. of Pennsylvania CRS
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Washington
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Seattle, Washington, United States, 98122
- University of Washington AIDS CRS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed if clinically indicated:
- Recombinant erythropoietin (rEPO) and G-CSF.
Allowed for symptomatic treatment of mild study drug toxicity:
- Antipyretics and analgesics (ibuprofen).
- Antihistamines (diphenhydramine HCl).
- Terfenadine or astemizole (but not allowed with concomitant antifungal or macrolide use).
- Systemic steroids.
Patients must have:
- HIV infection.
- CD4 count <= 250 cells/mm3 OR history or presence of thrush.
- No history of confirmed or probable pneumocystosis.
NOTE:
- Pregnant women are not excluded, but safety issues should be discussed with patient prior to enrollment.
- This study is appropriate for prisoner participation.
- Coenrollment in ongoing ACTG antiretroviral studies is permitted provided no new study drugs are added to the patient's drug regimen for 4 weeks before or after initiation of SMX/TMP.
Prior Medication:
Allowed:
- Prior aerosolized pentamidine and dapsone for primary PCP prophylaxis.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
- Known adverse reactions to sulfa, trimethoprim, or SMX/TMP.
- Inability to comply with dosing schedule or complete dosing record.
Concurrent Medication:
Excluded:
- Procysteine.
- Glutathione.
- N-acetylcysteine (NAC).
- Antihistamines (unless used for symptomatic treatment of study drug toxicity).
- Systemic corticosteroids (unless used for replacement purposes).
- Leucovorin calcium (unless used for symptomatic treatment of study drug toxicity).
- TMP or sulfa drugs outside of the study.
Prior Medication:
Excluded at any time:
- Prior SMX/TMP as primary PCP prophylaxis.
Excluded within 4 weeks prior to study entry:
- Initiation of antiretroviral agents.
- Initiation of anti-infective agents (including SMX/TMP for another indication).
Excluded within 2 weeks prior to study entry:
- Antihistamines.
- Procysteine.
- Glutathione.
- N-acetylcysteine (NAC).
- Systemic corticosteroids (unless used for replacement purposes).
- Leucovorin calcium.
- TMP and sulfa drugs separately.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Para MF
- Study Chair: Frame P
- Study Chair: Dohn MN
Publications and helpful links
General Publications
- Para MF, Dohn M, Frame P, Becker S, Finkelstein D, Walawander A. ACTG 268 trial - gradual initiation of trimethoprim/sulfamethoxazole (T/S) as primary prophylaxis for Pneumocystis carinii pneumonia (PCP). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:65 (abstract no 2)
- Para MF, Finkelstein D, Becker S, Dohn M, Walawander A, Black JR. Reduced toxicity with gradual initiation of trimethoprim-sulfamethoxazole as primary prophylaxis for Pneumocystis carinii pneumonia: AIDS Clinical Trials Group 268. J Acquir Immune Defic Syndr. 2000 Aug 1;24(4):337-43. doi: 10.1097/00126334-200008010-00007.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Lung Diseases, Fungal
- Pneumocystis Infections
- Pneumonia
- Pneumonia, Pneumocystis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Renal Agents
- Cytochrome P-450 CYP2C8 Inhibitors
- Trimethoprim
- Sulfamethoxazole
- Trimethoprim, Sulfamethoxazole Drug Combination
Other Study ID Numbers
- ACTG 268
- 11244 (Other Grant/Funding Number: PCORI)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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