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

This study has been completed.

Sponsors and 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: 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

MedlinePlus related topics:   AIDS    Pneumonia   

Drug Information available for:   Sulfamethoxazole    Trimethoprim    Trimethoprim-sulfamethoxazole combination   

U.S. FDA Resources

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   2500
Study Completion Date:   August 2007

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 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

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000748

Show 24 study locations  Show 24 Study Locations

Sponsors and Collaborators

Investigators
Study Chair:     W El-Sadr    
Study Chair:     R Luskin-Hawk    
  More Information


Click here for more information about Sulfamethoxazole-Trimethoprim  This link exits the ClinicalTrials.gov site
 

Publications:

Study ID Numbers:   CPCRA 006
First Received:   November 2, 1999
Last Updated:   September 26, 2008
ClinicalTrials.gov Identifier:   NCT00000748
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  

Study placed in the following topic categories:
Trimethoprim
Sexually Transmitted Diseases, Viral
Sulfamethoxazole
Acquired Immunodeficiency Syndrome
Trimethoprim-Sulfamethoxazole Combination
AIDS-Related Complex
Immunologic Deficiency Syndromes
Folic Acid
Virus Diseases
Mycoses
Pneumonia, Pneumocystis
Pneumocystis Infections
Respiratory Tract Diseases
Respiratory Tract Infections
HIV Infections
Lung Diseases
Sexually Transmitted Diseases
Retroviridae Infections
Pneumonia
Lung Diseases, Fungal

Additional relevant MeSH terms:
Anti-Infective Agents
RNA Virus Infections
Antiprotozoal Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists
Infection
Renal Agents
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on October 31, 2008




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