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| Sponsor: | Lederle Laboratories |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002002 |
Purpose
The primary objective of the study is to evaluate the effectiveness of l-leucovorin in preventing toxicity from high dose trimethoprim / sulfamethoxazole (TMP / SMX) used as a therapy for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.
| Condition | Intervention |
|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Trimethoprim Drug: Sulfamethoxazole Drug: Leucovorin calcium |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo Controlled Study of l-Leucovorin in Combination With Trimethoprim / Sulfamethoxazole in the Therapy of Pneumocystis Carinii Pneumonia in Patients With the Acquired Immunodeficiency Syndrome |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Contacts and Locations
More Information
| Study ID Numbers: | 056A, 76-9 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002002 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Trimethoprim-Sulfamethoxazole Combination AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Acquired Immunodeficiency Syndrome |
|
Anti-Infective Agents Antiprotozoal Agents Sexually Transmitted Diseases, Viral Trimethoprim Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Leucovorin Trimethoprim-Sulfamethoxazole Combination Renal Agents Antimalarials Pneumonia, Pneumocystis Mycoses Antiparasitic Agents Respiratory Tract Diseases |
Respiratory Tract Infections Therapeutic Uses Vitamins Micronutrients Retroviridae Infections Lung Diseases, Fungal RNA Virus Infections Vitamin B Complex Immune System Diseases Sulfamethoxazole Growth Substances Acquired Immunodeficiency Syndrome Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists |