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

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.

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Key information

Conditions

Pneumonia, Pneumocystis Carinii AIDS-Related Complex Acquired Immunodeficiency Syndrome Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Lung Diseases Lung Diseases, Fungal Mycoses Pneumocystis Infections Pneumonia Pneumonia, Pneumocystis RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Community Consortium of San Francisco, San Francisco, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sulfamethoxazole-Trimethoprim

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Nih

Collaborators

Glaxo Wellcome

Registry information

Important dates

Study completion: 1996
First posted: Aug 31, 2001
Registry last updated: Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed