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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: | NCT00000655 |
To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP.
Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.
Condition | Intervention | Phase |
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Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Atovaquone Drug: Sulfamethoxazole-Trimethoprim |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety Study |
Official Title: | A Randomized, Double-Blind Study of 566C80 Versus Septra (Trimethoprim/Sulfamethoxazole) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients |
Estimated Enrollment: | 300 |
Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.
Patients are randomized into one of two treatment groups to receive either (1) 566C80 for 21 days, or (2) SMX/TMP for 21 days. Patients will be stratified according to severity of PCP. Group A will be those with an arterial-alveolar (A-a) DO2 < 35 mm Hg. Group B will have an A-a DO2 of 35-45 mm Hg., and will also be required to receive therapy with Corticosteroids. All doses are taken with food. During the 21 days of treatment, patients are examined clinically for adverse effects and have hematology (blood-related) and clinical chemistry studies conducted a minimum of 2 times weekly. More frequent monitoring may be required at the discretion of the investigator. To evaluate the effectiveness of study medication, the clinical status of each patient is evaluated 2 to 3 times per week (e.g., dyspnea score, cough score, chest tightness/pain score, vital signs). Also, on days 7 and 21 of treatment, an arterial blood gas measurement and chest X-ray are performed. Patients who experience severe toxicities will be discontinued from the study and placed on alternative therapy. Patients will also be removed from study if they show significant clinical deterioration within the first 7 days of therapy or if there is no improvement after 10 days of therapy. This study involves a double placebo with one group randomized to receive oral 566C80 and placebo tablets which look like SMX/TMP while the other group will receive SMX/TMP and placebo tablets looking like 566C80.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patient must have the following:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Drugs likely to have anti-pneumocystis effect such as:
Patients with the following are excluded:
Prior Medication:
Excluded:
Study Chair: | Hughes WT |
Study ID Numbers: | ACTG 167, NIAID 90-CC-185, Protocol #03, FDA 53A, Project P71 |
Study First Received: | November 2, 1999 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00000655 |
Health Authority: | United States: Federal Government |
Trimethoprim-Sulfamethoxazole Combination AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Naphthoquinones |
Antifungal Agents Acquired Immunodeficiency Syndrome Sulfamethoxazole-Trimethoprim |
Opportunistic Infections Sexually Transmitted Diseases, Viral Trimethoprim Clotrimazole Miconazole Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis Mycoses Respiratory Tract Diseases Respiratory Tract Infections AIDS-Related Opportunistic Infections Retroviridae Infections Lung Diseases, Fungal |
Sulfamethoxazole Pneumocystosis Acquired Immunodeficiency Syndrome Tioconazole Immunologic Deficiency Syndromes Folic Acid Virus Diseases Pneumocystis Infections Atovaquone HIV Infections Lung Diseases Sexually Transmitted Diseases Pneumonia |
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 |