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COMPLETED Phase 4

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

NCT00000816 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00000816

The ClinicalTrials.gov registry entry for NCT00000816 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 370 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00000816 reports 20 study locations spanning 9 distinct geographic areas — top geographies include California, Illinois, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00000816?

The interventions under investigation include: Sulfamethoxazole-Trimethoprim (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00000816?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial