Completed

Phase 3
Age: 13Years +
All Genders
ID00000748

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04

2500

Participants Needed

24

Research Sites

N/A

Total Duration

On this page

Sponsors

N

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

G

Glaxo Wellcome

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 24 locations

1

Community Consortium of San Francisco

San Francisco, California, United States, 94110

Status Unknown

2

Stanford Univ School of Medicine

Stanford, California, United States, 94305

Status Unknown

3

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States, 80204

Status Unknown

4

Wilmington Hosp / Med Ctr of Delaware

Wilmington, Delaware, United States, 19899

Status Unknown

5

Veterans Administration Med Ctr / Regional AIDS Program

Washington D.C., District of Columbia, United States, 20422

Status Unknown

6

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States, 30308

Status Unknown

7

AIDS Research Alliance - Chicago

Chicago, Illinois, United States, 60657

Status Unknown

8

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, United States, 70112

Status Unknown

9

Baltimore Trials

Baltimore, Maryland, United States, 21201

Status Unknown

10

Univ of Maryland at Baltimore

Baltimore, Maryland, United States, 21201

Status Unknown

11

Comprehensive AIDS Alliance of Detroit

Detroit, Michigan, United States, 48201

Status Unknown

12

Henry Ford Hosp

Detroit, Michigan, United States, 48202

Status Unknown

13

Southern New Jersey AIDS Cln Trials / Dept of Med

Camden, New Jersey, United States, 08103

Status Unknown

14

North Jersey Community Research Initiative

Newark, New Jersey, United States, 07103

Status Unknown

15

Partners Research

Albuquerque, New Mexico, United States, 87131

Status Unknown

16

Univ Hosp / HIV - ID Clinic

Albuquerque, New Mexico, United States, 87131

Status Unknown

17

Addiction Research and Treatment Corp

Brooklyn, New York, United States, 11201

Status Unknown

18

Clinical Directors Network of Region II

New York, New York, United States, 10011

Status Unknown

19

Harlem AIDS Treatment Group / Harlem Hosp Ctr

New York, New York, United States, 10037

Status Unknown

20

Bronx Lebanon Hosp Ctr

The Bronx, New York, United States, 10456

Status Unknown

21

Portland Veterans Adm Med Ctr / Rsch & Education Grp

Portland, Oregon, United States, 97210

Status Unknown

22

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States, 19107

Status Unknown

23

Richmond AIDS Consortium

Richmond, Virginia, United States, 23298

Status Unknown

24

Univ of Washington / Pacific Med Ctr

Seattle, Washington, United States, 98144

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

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).

W M El-Sadr, R Luskin-Hawk, T M Yurik...

https://pubmed.ncbi.nlm.nih.gov/10589887