Status:

COMPLETED

A Randomized, Comparative, Prospective Study of Daily Trimethoprim / Sulfamethoxazole (TMS) and Thrice-Weekly TMS for Prophylaxis Against PCP in HIV-Infected Patients

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Glaxo Wellcome

Conditions:

Pneumonia, Pneumocystis Carinii

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE3

Brief Summary

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-ri...

Detailed Description

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 caus...

Eligibility Criteria

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

November 1 1996

Estimated Enrollment :

2500 Patients enrolled

Trial Details

Trial ID

NCT00000748

End Date

November 1 1996

Last Update

November 4 2021

Active Locations (24)

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Page 1 of 6 (24 locations)

1

Community Consortium of San Francisco

San Francisco, California, United States, 94110

2

Stanford Univ School of Medicine

Stanford, California, United States, 94305

3

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States, 80204

4

Wilmington Hosp / Med Ctr of Delaware

Wilmington, Delaware, United States, 19899