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

NCT00000816 | Completed Phase 4

• 2 other identifiers: ACTG 26811244
• Study Type: interventional
• Target: 370
• Locations: 3 countries
• Sites: 42

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.

Conditions

Pneumonia, Pneumocystis Carinii; HIV Infections

Keywords

Trimethoprim-Sulfamethoxazole Combination; Pneumonia, Pneumocystis carinii; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Sulfamethoxazole-Trimethoprim

Interventions

Sulfamethoxazole-Trimethoprim DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Allowed if clinically indicated:
• Recombinant erythropoietin (rEPO) and G-CSF.
• Allowed for symptomatic treatment of mild study drug toxicity:
• Antipyretics and analgesics (ibuprofen).
• Antihistamines (diphenhydramine HCl).
• Terfenadine or astemizole (but not allowed with concomitant antifungal or macrolide use).
• Systemic steroids.
• Patients must have:
• HIV infection.
• CD4 count \<= 250 cells/mm3 OR history or presence of thrush.
• No history of confirmed or probable pneumocystosis.
• NOTE:
• Pregnant women are not excluded, but safety issues should be discussed with patient prior to enrollment.
• This study is appropriate for prisoner participation.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Known adverse reactions to sulfa, trimethoprim, or SMX/TMP.
• Inability to comply with dosing schedule or complete dosing record.
• Concurrent Medication:
• Excluded:
• Procysteine.
• Glutathione.
• N-acetylcysteine (NAC).
• Antihistamines (unless used for symptomatic treatment of study drug toxicity).
• Systemic corticosteroids (unless used for replacement purposes).
• Leucovorin calcium (unless used for symptomatic treatment of study drug toxicity).
• TMP or sulfa drugs outside of the study.
• Prior Medication:
• Excluded at any time:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Glaxo Wellcome: collaborator

Study Sites (42)

USC CRS

Los Angeles, California, 90033, United States

Location

Stanford CRS

Palo Alto, California, 94305, United States

Location

Ucsf Aids Crs

San Francisco, California, 94110, United States

Location

Santa Clara Valley Med. Ctr.

San Jose, California, United States

Location

San Mateo County AIDS Program

San Mateo, California, United States

Location

Harbor-UCLA Med. Ctr. CRS

Torrance, California, 90502, United States

Location

University of Colorado Hospital CRS

Aurora, Colorado, 80262, United States

Location

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, 32209, United States

Location

Univ. of Miami AIDS CRS

Miami, Florida, 33136, United States

Location

Queens Med. Ctr.

Honolulu, Hawaii, 96816, United States

Location

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, 96816, United States

Location

Northwestern University CRS

Chicago, Illinois, 60611, United States

Location

Cook County Hosp. CORE Ctr.

Chicago, Illinois, 60612, United States

Location

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, 60612, United States

Location

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, 46202, United States

Location

Methodist Hosp. of Indiana

Indianapolis, Indiana, 46202, United States

Location

Tulane/LSU Maternal/Child CRS

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, 02114, United States

Location

Bmc Actg Crs

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, 02215, United States

Location

Beth Israel Deaconess Med. Ctr., ACTG CRS

Boston, Massachusetts, 02215, United States

Location

Hennepin County Med. Ctr., Div. of Infectious Diseases

Minneapolis, Minnesota, 55415, United States

Location

University of Minnesota, ACTU

Minneapolis, Minnesota, 55455, United States

Location

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, 63112, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.

Omaha, Nebraska, 68198, United States

Location

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, 14215, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, 10029, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, United States

Location

Unc Aids Crs

Chapel Hill, North Carolina, 27599, United States

Location

Carolinas HealthCare System, Carolinas Med. Ctr.

Charlotte, North Carolina, 28203, United States

Location

Regional Center for Infectious Disease, Wendover Medical Center CRS

Greensboro, North Carolina, 27401, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267, United States

Location

MetroHealth CRS

Cleveland, Ohio, 44109, United States

Location

Case CRS

Cleveland, Ohio, United States

Location

The Ohio State Univ. AIDS CRS

Columbus, Ohio, 43210, United States

Location

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, 19104, United States

Location

University of Washington AIDS CRS

Seattle, Washington, 98122, United States

Location

San Juan City Hosp. PR NICHD CRS

San Juan, 00936, Puerto Rico

Location

Mbeya Med. Research Program, Mbeya Referral Hosp. CRS

Mbeya, Tanzania

Location

Related Publications (2)

• Para MF, Dohn M, Frame P, Becker S, Finkelstein D, Walawander A. ACTG 268 trial - gradual initiation of trimethoprim/sulfamethoxazole (T/S) as primary prophylaxis for Pneumocystis carinii pneumonia (PCP). Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:65 (abstract no 2)

  BACKGROUND

• Para MF, Finkelstein D, Becker S, Dohn M, Walawander A, Black JR. Reduced toxicity with gradual initiation of trimethoprim-sulfamethoxazole as primary prophylaxis for Pneumocystis carinii pneumonia: AIDS Clinical Trials Group 268. J Acquir Immune Defic Syndr. 2000 Aug 1;24(4):337-43. doi: 10.1097/00126334-200008010-00007.

  PMID: 11015150 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Pneumocystis; HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Para MF

  STUDY CHAIR

• Dohn MN

  STUDY CHAIR

• Frame P

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: September 1, 1996
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

TA (1); US (40); PR (1)