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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Glaxo Wellcome |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000655 |
Purpose
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 |
|---|---|---|
|
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.
Eligibility| 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:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Univ of California / San Diego Treatment Ctr | |
| San Diego, California, United States, 921036325 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 941102859 | |
| UCLA CARE Ctr | |
| Los Angeles, California, United States, 90095 | |
| Dr Marcus Conant | |
| San Francisco, California, United States, 94115 | |
| USC | |
| Los Angeles, California, United States, 90033 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| Kaiser Foundation Hosp | |
| Harbor City, California, United States, 90710 | |
| Dr Richard Meyer | |
| Los Angeles, California, United States, 90048 | |
| Infectious Disease Med Group | |
| Oakland, California, United States, 94609 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| Veterans Administration Med Ctr | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Georgia | |
| Dr Winkler Weinberg | |
| Roswell, Georgia, United States, 30076 | |
| United States, Maryland | |
| Johns Hopkins Univ School of Medicine | |
| Baltimore, Maryland, United States, 21205 | |
| Natl Inst of Allergy & Infect Dis / Cln Ctr | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Missouri | |
| Washington Univ School of Medicine | |
| St Louis, Missouri, United States, 63108 | |
| United States, New York | |
| Saint Vincent's Hosp and Med Ctr | |
| New York, New York, United States, 10011 | |
| Beth Israel Med Ctr / Peter Krueger Clinic | |
| New York, New York, United States, 10003 | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| United States, North Carolina | |
| Duke Univ Med Ctr | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Univ of Cincinnati | |
| Cincinnati, Ohio, United States, 452670405 | |
| United States, Oregon | |
| Good Samaritan Hosp | |
| Portland, Oregon, United States, 972103079 | |
| United States, Pennsylvania | |
| Buckley Braffman Stern Med Associates | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Tennessee | |
| The Regional Medical Ctr, Memphis | |
| Memphis, Tennessee, United States, 38105 | |
| Regional Med Ctr at Memphis | |
| Memphis, Tennessee, United States, 38103 | |
| United States, Texas | |
| Plaza Med Ctr | |
| Houston, Texas, United States, 77004 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| Belgium | |
| CHU Saint Pierre | |
| Brussels, Belgium | |
| Canada, British Columbia | |
| Dr Julio S G Montaner | |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| Wellesley Hosp | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Montreal Gen Hosp | |
| Montreal, Quebec, Canada | |
| France | |
| Hopital Bichat - Claude Bernard | |
| Paris, France | |
| Germany | |
| August-Viktoria-Krankenhaus Chefarst derII Inneren Abteilung | |
| Berlin 41, Germany | |
| Universitat Munchen / Medizinische Poliklinik | |
| Munich 2, Germany | |
| Netherlands | |
| Natac Med Centre | |
| Amsterdam, Netherlands | |
| Puerto Rico | |
| San Juan Veterans Administration Med Ctr | |
| San Juan, Puerto Rico, 009275800 | |
| United Kingdom | |
| Kobler Centre / Saint Stephen's Hosp | |
| London, United Kingdom | |
| Saint Mary's Hosp | |
| London, United Kingdom | |
| Study Chair: | Hughes WT |
More Information
| 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 History of Changes |
| Health Authority: | United States: Federal Government |
|
Trimethoprim-Sulfamethoxazole Combination AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Naphthoquinones |
Antifungal Agents Acquired Immunodeficiency Syndrome Sulfamethoxazole-Trimethoprim |
|
Anti-Infective Agents Communicable Diseases Antiprotozoal Agents Sexually Transmitted Diseases, Viral Trimethoprim Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Trimethoprim-Sulfamethoxazole Combination Renal Agents Infection Antimalarials Pneumonia, Pneumocystis Mycoses Antiparasitic Agents Respiratory Tract Diseases |
Respiratory Tract Infections Therapeutic Uses Retroviridae Infections Lung Diseases, Fungal RNA Virus Infections Immune System Diseases Sulfamethoxazole Acquired Immunodeficiency Syndrome Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Pneumocystis Infections |