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| Sponsor: | Jacobus Pharmaceutical |
|---|---|
| Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000640 |
Purpose
To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP.
The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Primaquine Drug: Sulfamethoxazole-Trimethoprim Drug: Dapsone Drug: Clindamycin |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind |
| Official Title: | A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Trimethoprim / Sulfamethoxazole in the Treatment of Mild-to-Moderate PCP in Patients With AIDS |
| Estimated Enrollment: | 290 |
The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.
Patients with confirmed PCP are randomized into one of three treatment groups. Group A receives SMX/TMP. Half of group A receives dapsone placebo (placebo is an inactive substance) daily plus trimethoprim placebo; the other half receives clindamycin placebo plus primaquine placebo. Group B is given dapsone plus trimethoprim. Half of group B receives SMX/TMP placebo; the other half receives clindamycin placebo plus primaquine placebo. Group C is given clindamycin plus primaquine. Half of group C receives SMX/TMP placebo, the other half receives dapsone placebo plus trimethoprim placebo. Treatment lasts 21 days; dosages will be adjusted for patients weighing less than 50 kg and more than 80 kg. Patients with a history of intolerance to SMX/TMP for whom rechallenge is considered medically contraindicated may be randomized to one of the non-sulfamethoxazole-containing arms.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have the following:
Prior Medication:
Allowed:
Required:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions and diseases are excluded:
Positive screen for glucose-6-phosphate dehydrogenase deficiency.
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Requirement for other medications potentially effective in the treatment of Pneumocystis carinii pneumonia (PCP) (e.g., pyrimethamine and sulfadiazine).
Inability to take oral therapy.
Prior Medication:
Excluded:
Contacts and Locations
Hide Study Locations| United States, California | |
| San Francisco Veterans Administration Med Ctr | |
| San Francisco, California, United States, 94121 | |
| Univ of Southern California / LA County USC Med Ctr | |
| Los Angeles, California, United States, 900331079 | |
| Harbor UCLA Med Ctr | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Georgetown Univ Med Ctr | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Hawaii | |
| Univ of Hawaii | |
| Honolulu, Hawaii, United States, 96816 | |
| United States, Illinois | |
| Rush Presbyterian - Saint Luke's Med Ctr | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Hosp | |
| Indianapolis, Indiana, United States, 462025250 | |
| Methodist Hosp of Indiana / Life Care Clinic | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Louisiana | |
| Louisiana State Univ Med Ctr / Tulane Med School | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Massachusetts | |
| Harvard (Massachusetts Gen Hosp) | |
| Boston, Massachusetts, United States, 02114 | |
| Beth Israel Deaconess Med Ctr | |
| Boston, Massachusetts, United States, 02215 | |
| Baystate Med Ctr of Springfield | |
| Springfield, Massachusetts, United States, 01199 | |
| Univ of Massachusetts Med Ctr | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| Univ of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, New York | |
| Montefiore Drug Treatment Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Univ of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| Samaritan Village Inc / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Nassau County Med Ctr | |
| East Meadow, New York, United States, 11554 | |
| SUNY - Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| Montefiore Family Health Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10461 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| Jack Weiler Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10465 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Saint Luke's - Roosevelt Hosp Ctr | |
| New York, New York, United States, 10025 | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
| Bronx, New York, United States, 10461 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| SUNY / Erie County Med Ctr at Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Beth Israel Med Ctr | |
| New York, New York, United States, 10003 | |
| SUNY / Health Sciences Ctr at Brooklyn | |
| Brooklyn, New York, United States, 112032098 | |
| North Central Bronx Hosp / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| United States, North Carolina | |
| Carolinas Med Ctr | |
| Charlotte, North Carolina, United States, 28203 | |
| Univ of North Carolina | |
| Chapel Hill, North Carolina, United States, 275997215 | |
| Moses H Cone Memorial Hosp | |
| Greensboro, North Carolina, United States, 27401 | |
| United States, Ohio | |
| Case Western Reserve Univ | |
| Cleveland, Ohio, United States, 44106 | |
| Ohio State Univ Hosp Clinic | |
| Columbus, Ohio, United States, 432101228 | |
| Med College of Ohio | |
| Toledo, Ohio, United States, 43699 | |
| United States, Oregon | |
| Oregon Health Sciences Univ / Children's Hosp of Los Angeles | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Univ of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Hemophilia Ctr of Western PA / Univ of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, Texas | |
| Univ of Texas Galveston | |
| Galveston, Texas, United States, 775550435 | |
| Study Chair: | Safrin S | |
| Study Chair: | Black JR |
More Information
| Study ID Numbers: | ACTG 108 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000640 History of Changes |
| Health Authority: | Unspecified |
|
Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis carinii Primaquine Dapsone |
Drug Therapy, Combination Acquired Immunodeficiency Syndrome Clindamycin Sulfamethoxazole-Trimethoprim |
|
Anti-Infective Agents Antiprotozoal Agents Trimethoprim Sexually Transmitted Diseases, Viral Clindamycin Slow Virus Diseases Primaquine Molecular Mechanisms of Pharmacological Action Trimethoprim-Sulfamethoxazole Combination Renal Agents Infection Antimalarials Anti-Bacterial Agents Pneumonia, Pneumocystis Mycoses |
Antiparasitic Agents Respiratory Tract Diseases Respiratory Tract Infections Therapeutic Uses Dapsone Retroviridae Infections Lung Diseases, Fungal RNA Virus Infections Immune System Diseases Clindamycin-2-phosphate Sulfamethoxazole Acquired Immunodeficiency Syndrome Anti-Infective Agents, Urinary Enzyme Inhibitors Folic Acid Antagonists |