A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients
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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 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Primary Purpose: Treatment |
| 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: | November 1996 |
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:
- HIV infection.
- CD4 count <= 200 cells/mm3 OR a history of prior PCP.
- No active pneumocystosis. Patients or their guardians must sign informed consent. Pregnant patients are eligible at the clinician's discretion. Patients who do not meet required laboratory values may be eligible at the discretion of the clinician.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Known treatment-limiting reaction to sulfonamides or trimethoprim.
Concurrent Medication:
Excluded:
- Other PCP prophylaxis or medication with anti-PCP activity.
Contacts and Locations
Show 24 Study Locations| Study Chair: | W El-Sadr | |
| Study Chair: | R Luskin-Hawk |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000748 History of Changes |
| Other Study ID Numbers: | CPCRA 006, 11558 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Trimethoprim-Sulfamethoxazole Combination Pneumonia, Pneumocystis carinii Acquired Immunodeficiency Syndrome AIDS-Related Complex Sulfamethoxazole-Trimethoprim |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Sulfamethoxazole Trimethoprim Trimethoprim-Sulfamethoxazole Combination Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |
ClinicalTrials.gov processed this record on March 14, 2013
