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NCT00000816 · ClinicalTrials.gov registry record · Phase 4

Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis

A Phase 4 study of HIV Infections and Pneumonia, Pneumocystis Carinii, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 4
Development phase
370
Enrollment target
20
Study locations

NCT00000816 is a Phase 4 study of HIV Infections and Pneumonia, Pneumocystis Carinii that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 370 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT00000816, a Phase 4 study of HIV Infections and Pneumonia, Pneumocystis Carinii, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 4
Development phase
370 participants
Enrollment target
20
Study locations

Study Summary

To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients. Although a number of clinical trials have demonstrated the superiority of SMX/TMP for PCP prophylaxis, the incidence of adverse reactions to this medication is high. In a pilot study in which patients were initiated with SMX/TMP prophylaxis by gradually increasing the dose over 2 weeks, no significant adverse reactions have occurred.

Conditions Studied

HIV Infections Pneumonia, Pneumocystis Carinii

Interventions

  • DRUG Sulfamethoxazole-Trimethoprim

Study Locations (20)

California

  • USC CRS - Los Angeles
  • Stanford CRS - Palo Alto
  • Ucsf Aids Crs - San Francisco
  • Santa Clara Valley Med. Ctr. - San Jose
  • San Mateo County AIDS Program - San Mateo
  • Harbor-UCLA Med. Ctr. CRS - Torrance

Illinois

  • Northwestern University CRS - Chicago
  • Cook County Hosp. CORE Ctr. - Chicago
  • Rush Univ. Med. Ctr. ACTG CRS - Chicago

Florida

  • Univ. of Florida Jacksonville NICHD CRS - Jacksonville
  • Univ. of Miami AIDS CRS - Miami

Hawaii

  • Queens Med. Ctr. - Honolulu
  • Univ. of Hawaii at Manoa, Leahi Hosp. - Honolulu

Indiana

  • Indiana Univ. School of Medicine, Infectious Disease Research Clinic - Indianapolis
  • Methodist Hosp. of Indiana - Indianapolis

Massachusetts

  • Massachusetts General Hospital ACTG CRS - Boston
  • Bmc Actg Crs - Boston

Colorado

  • University of Colorado Hospital CRS - Aurora

Louisiana

  • Tulane/LSU Maternal/Child CRS - New Orleans

Trial Details

FieldValue
Enrollment Target 370 participants
Est. Completion 1996-09
Phase Phase 4

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT00000816

The ClinicalTrials.gov registry entry for NCT00000816 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (17% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Sulfamethoxazole-Trimethoprim is the first listed.

NCT00000816 reports 20 study locations spanning 9 distinct geographic areas - top geographies include California, Illinois, Florida.

Frequently Asked Questions

What is clinical trial NCT00000816 about?

NCT00000816 is a clinical study titled "Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis Carinii Pneumonia Prophylaxis". To determine whether gradual initiation of sulfamethoxazole/trimethoprim (SMX/TMP) reduces the incidence of treatment-limiting adverse reactions compared to the routine initiation of the drugs for Pneumocystis carinii pneumonia (PCP) prophylaxis in HIV-infected patients. Although a number of clinic...

What is the current status of trial NCT00000816?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 370 participants. Estimated completion is 1996-09.

What conditions does trial NCT00000816 study?

This clinical trial studies the following conditions: HIV Infections, Pneumonia, Pneumocystis Carinii.

What interventions are being tested in trial NCT00000816?

The interventions under investigation include: Sulfamethoxazole-Trimethoprim (DRUG).

Who is sponsoring clinical trial NCT00000816?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00000816 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.