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

Phase 4

Completed

• Conditions: Pneumonia, Pneumocystis Carinii; HIV Infections

• Registration Number: NCT00000816
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief 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.

Detailed Description

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.

Patients are randomized to receive either gradually increasing doses of SMX/TMP suspension or routine daily initiation of SMX/TMP double strength (DS) tablets for 2 weeks. All patients will then be switched over to receive open-label SMX/TMP DS tablets daily for 10 weeks.

Study Timeline

• Study Completion: 1996-09
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-27
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 370

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (42)

USC CRS; 🇺🇸 Los Angeles, California, United States

Stanford CRS; 🇺🇸 Palo Alto, California, United States

Ucsf Aids Crs; 🇺🇸 San Francisco, California, United States

Santa Clara Valley Med. Ctr.; 🇺🇸 San Jose, California, United States

San Mateo County AIDS Program; 🇺🇸 San Mateo, California, United States

Harbor-UCLA Med. Ctr. CRS; 🇺🇸 Torrance, California, United States

University of Colorado Hospital CRS; 🇺🇸 Aurora, Colorado, United States

Univ. of Florida Jacksonville NICHD CRS; 🇺🇸 Jacksonville, Florida, United States

Univ. of Miami AIDS CRS; 🇺🇸 Miami, Florida, United States

Queens Med. Ctr.; 🇺🇸 Honolulu, Hawaii, United States

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