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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000816 |
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.
Condition | Intervention | Phase |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Sulfamethoxazole-Trimethoprim |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Gradual Initiation of Trimethoprim/Sulfamethoxazole as Primary Pneumocystis Carinii Pneumonia Prophylaxis |
Estimated Enrollment: | 370 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed if clinically indicated:
Allowed for symptomatic treatment of mild study drug toxicity:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded at any time:
Excluded within 4 weeks prior to study entry:
Excluded within 2 weeks prior to study entry:
Study Chair: | Para MF | |
Study Chair: | Dohn MN | |
Study Chair: | Frame P |
Study ID Numbers: | ACTG 268 |
Study First Received: | November 2, 1999 |
Last Updated: | January 25, 2006 |
ClinicalTrials.gov Identifier: | NCT00000816 |
Health Authority: | United States: Federal Government |
Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis carinii Acquired Immunodeficiency Syndrome AIDS-Related Complex Sulfamethoxazole-Trimethoprim |
Trimethoprim Sexually Transmitted Diseases, Viral Sulfamethoxazole Pneumocystosis Acquired Immunodeficiency Syndrome Trimethoprim-Sulfamethoxazole Combination AIDS-Related Complex Immunologic Deficiency Syndromes Folic Acid Virus Diseases Mycoses |
Pneumonia, Pneumocystis Pneumocystis Infections Respiratory Tract Diseases Respiratory Tract Infections HIV Infections Lung Diseases Sexually Transmitted Diseases Retroviridae Infections Pneumonia Lung Diseases, Fungal |
Anti-Infective Agents RNA Virus Infections Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Enzyme Inhibitors Anti-Infective Agents, Urinary |
Folic Acid Antagonists Infection Renal Agents Pharmacologic Actions Antimalarials Antiparasitic Agents Therapeutic Uses Lentivirus Infections |