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CompletedNCT00000748Updated Nov 4, 2021

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

A Phase 3 interventional study of Sulfamethoxazole-Trimethoprim in Pneumonia, Pneumocystis Carinii and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 24 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2021-11-04.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
2,500
Ages
13 Years and older
Sex
All
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Study 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-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.

Read the 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.

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Conditions studied

  • Pneumonia, Pneumocystis Carinii
  • HIV Infections

Keywords

  • Trimethoprim-Sulfamethoxazole Combination
  • Pneumonia, Pneumocystis carinii
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Sulfamethoxazole-Trimethoprim
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 2,500 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Intervention model
Parallel assignment
Enrollment
2,500 participants

Interventions

  • DrugSulfamethoxazole-Trimethoprim
06

Study locations

24 sites
  • Community Consortium of San Francisco
    San Francisco, California 94110, United States
  • Stanford Univ School of Medicine
    Stanford, California 94305, United States
  • Denver CPCRA / Denver Public Hlth
    Denver, Colorado 80204, United States
  • Wilmington Hosp / Med Ctr of Delaware
    Wilmington, Delaware 19899, United States
  • Veterans Administration Med Ctr / Regional AIDS Program
    Washington, District of Columbia 20422, United States
  • AIDS Research Consortium of Atlanta
    Atlanta, Georgia 30308, United States
  • AIDS Research Alliance - Chicago
    Chicago, Illinois 60657, United States
  • Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
    New Orleans, Louisiana 70112, United States
  • Baltimore Trials
    Baltimore, Maryland 21201, United States
  • Univ of Maryland at Baltimore
    Baltimore, Maryland 21201, United States
  • Comprehensive AIDS Alliance of Detroit
    Detroit, Michigan 48201, United States
  • Henry Ford Hosp
    Detroit, Michigan 48202, United States
  • Southern New Jersey AIDS Cln Trials / Dept of Med
    Camden, New Jersey 08103, United States
  • North Jersey Community Research Initiative
    Newark, New Jersey 07103, United States
  • Partners Research
    Albuquerque, New Mexico 87131, United States
  • Univ Hosp / HIV - ID Clinic
    Albuquerque, New Mexico 87131, United States
  • Bronx Lebanon Hosp Ctr
    Bronx, New York 10456, United States
  • Addiction Research and Treatment Corp
    Brooklyn, New York 11201, United States
  • Clinical Directors Network of Region II
    New York, New York 10011, United States
  • Harlem AIDS Treatment Group / Harlem Hosp Ctr
    New York, New York 10037, United States
  • Portland Veterans Adm Med Ctr / Rsch & Education Grp
    Portland, Oregon 97210, United States
  • Philadelphia FIGHT
    Philadelphia, Pennsylvania 19107, United States
  • Richmond AIDS Consortium
    Richmond, Virginia 23298, United States
  • Univ of Washington / Pacific Med Ctr
    Seattle, Washington 98144, United States
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References and documents

Publications

  • Simon PM, Morse EV, Besch L. Barriers to compliance among women co-enrolled in a PCP prophylaxis and compliance protocol. HIV Infect Women Conf. 1995 Feb 22-24:P109
  • El-Sadr WM, Luskin-Hawk R, Yurik TM, Walker J, Abrams D, John SL, Sherer R, Crane L, Labriola A, Caras S, Pulling C, Hafner R. A randomized trial of daily and thrice-weekly trimethoprim-sulfamethoxazole for the prevention of Pneumocystis carinii pneumonia in human immunodeficiency virus-infected persons. Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA). Clin Infect Dis. 1999 Oct;29(4):775-83. doi: 10.1086/520433. PubMed 10589887 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000748
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Glaxo Wellcome
Responsible party
Sponsor
First posted
Aug 31, 2001
Completion
Nov 1996
Last update
Nov 4, 2021

Study contacts

W El-Sadr
study chair
R Luskin-Hawk
study chair
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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