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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: | NCT00000748 |
Purpose
To compare the safety and efficacy of two dosage regimens (daily and thrice-weekly) of sulfamethoxazole/trimethoprim (SMX/TMP; TMS) in the prevention of Pneumocystis carinii pneumonia (PCP) in high-risk HIV-infected patients.
Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of PCP and may be effective in preventing PCP in patients who have never developed it. Because SMX/TMP can cause side effects, this study will attempt to determine the safest and most effective dose of this combination.
| Condition | Intervention | Phase |
|---|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Sulfamethoxazole-Trimethoprim |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety Study |
| Official Title: | A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients |
| Estimated Enrollment: | 2500 |
| Study Completion Date: | August 2007 |
Previous tests have shown that SMX/TMP given daily is effective in preventing recurrence of PCP and may be effective in preventing PCP in patients who have never developed it. Because SMX/TMP can cause side effects, this study will attempt to determine the safest and most effective dose of this combination.
Patients receive SMX/TMP orally on a daily or thrice-weekly basis. Patients are clinically evaluated every 4 months. Patients on daily SMX/TMP who develop a drug-related toxicity may be switched to thrice-weekly SMX/TMP. Duration of follow-up is 12 months.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Concurrent Medication:
Excluded:
Contacts and Locations
Hide Study Locations| United States, California | |
| Community Consortium of San Francisco | |
| San Francisco, California, United States, 94110 | |
| Stanford Univ School of Medicine | |
| Stanford, California, United States, 943055107 | |
| United States, Colorado | |
| Denver CPCRA / Denver Public Hlth | |
| Denver, Colorado, United States, 802044507 | |
| United States, Delaware | |
| Wilmington Hosp / Med Ctr of Delaware | |
| Wilmington, Delaware, United States, 19899 | |
| United States, District of Columbia | |
| Veterans Administration Med Ctr / Regional AIDS Program | |
| Washington, District of Columbia, United States, 20422 | |
| United States, Georgia | |
| AIDS Research Consortium of Atlanta | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Illinois | |
| AIDS Research Alliance - Chicago | |
| Chicago, Illinois, United States, 60657 | |
| United States, Louisiana | |
| Louisiana Comm AIDS Rsch Prog / Tulane Univ Med | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Univ of Maryland at Baltimore | |
| Baltimore, Maryland, United States, 21201 | |
| Baltimore Trials | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| Henry Ford Hosp | |
| Detroit, Michigan, United States, 48202 | |
| Comprehensive AIDS Alliance of Detroit | |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| North Jersey Community Research Initiative | |
| Newark, New Jersey, United States, 071032842 | |
| Southern New Jersey AIDS Cln Trials / Dept of Med | |
| Camden, New Jersey, United States, 08103 | |
| United States, New Mexico | |
| Univ Hosp / HIV - ID Clinic | |
| Albuquerque, New Mexico, United States, 87131 | |
| Partners Research | |
| Albuquerque, New Mexico, United States, 871315271 | |
| United States, New York | |
| Harlem AIDS Treatment Group / Harlem Hosp Ctr | |
| New York, New York, United States, 10037 | |
| Bronx Lebanon Hosp Ctr | |
| Bronx, New York, United States, 10456 | |
| Clinical Directors Network of Region II | |
| New York, New York, United States, 10011 | |
| Addiction Research and Treatment Corp | |
| Brooklyn, New York, United States, 11201 | |
| United States, Oregon | |
| Portland Veterans Adm Med Ctr / Rsch & Education Grp | |
| Portland, Oregon, United States, 972109951 | |
| United States, Pennsylvania | |
| Philadelphia FIGHT | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Virginia | |
| Richmond AIDS Consortium | |
| Richmond, Virginia, United States, 23298 | |
| United States, Washington | |
| Univ of Washington / Pacific Med Ctr | |
| Seattle, Washington, United States, 98144 | |
| Study Chair: | W El-Sadr | |
| Study Chair: | R Luskin-Hawk |
More Information
| Study ID Numbers: | CPCRA 006 |
| Study First Received: | November 2, 1999 |
| Last Updated: | September 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00000748 History of Changes |
| Health Authority: | United States: Federal Government |
|
Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis carinii Acquired Immunodeficiency Syndrome AIDS-Related Complex Sulfamethoxazole-Trimethoprim |
|
Anti-Infective Agents 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 HIV Infections |
