A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides

October 27, 2021 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts <= 200 cells/mm3 or <= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides.

Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.

Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months.

Study Type

Interventional

Enrollment

700

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tanzania
      • Mbeya, Tanzania
        • Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Alabama Therapeutics CRS
    • California
      • Los Angeles, California, United States, 900331079
        • USC CRS
      • Palo Alto, California, United States, 943055107
        • Stanford CRS
      • San Diego, California, United States, 921036325
        • Ucsd, Avrc Crs
      • San Francisco, California, United States, 941102859
        • Ucsf Aids Crs
      • San Jose, California, United States, 951282699
        • Santa Clara Valley Med. Ctr.
      • San Mateo, California, United States
        • San Mateo County AIDS Program
      • Torrance, California, United States, 90502
        • Harbor-UCLA Med. Ctr. CRS
    • Colorado
      • Aurora, Colorado, United States, 80262
        • University of Colorado Hospital CRS
    • District of Columbia
      • Washington, District of Columbia, United States, 20059
        • Howard University Hosp., Div. of Infectious Diseases, ACTU
    • Florida
      • Miami, Florida, United States, 331361013
        • Univ. of Miami AIDS CRS
    • Georgia
      • Atlanta, Georgia, United States, 303652225
        • Emory Univ. Hemophilia Program Office
    • Hawaii
      • Honolulu, Hawaii, United States, 96816
        • Univ. of Hawaii at Manoa, Leahi Hosp.
      • Honolulu, Hawaii, United States, 96816
        • Queens Med. Ctr.
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp. CORE Ctr.
      • Chicago, Illinois, United States, 60611
        • Northwestern University CRS
      • Chicago, Illinois, United States, 60612
        • Rush Univ. Med. Ctr. ACTG CRS
      • Chicago, Illinois, United States, 60640
        • Weiss Memorial Hosp.
    • Indiana
      • Indianapolis, Indiana, United States, 462025250
        • Indiana Univ. School of Medicine, Infectious Disease Research Clinic
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Univ. of Iowa Healthcare, Div. of Infectious Diseases
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Adult AIDS CRS
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Bmc Actg Crs
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess - East Campus A0102 CRS
      • Boston, Massachusetts, United States
        • Massachusetts General Hospital ACTG CRS
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota, ACTU
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Med. Ctr., Div. of Infectious Diseases
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington U CRS
      • Saint Louis, Missouri, United States
        • St. Louis ConnectCare, Infectious Diseases Clinic
    • Nebraska
      • Omaha, Nebraska, United States
        • Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
    • New York
      • Buffalo, New York, United States, 13210
        • SUNY - Buffalo, Erie County Medical Ctr.
      • New York, New York, United States
        • Beth Israel Med. Ctr. (Mt. Sinai)
      • New York, New York, United States
        • NY Univ. HIV/AIDS CRS
      • Rochester, New York, United States, 14642
        • Univ. of Rochester ACTG CRS
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Unc Aids Crs
      • Charlotte, North Carolina, United States, 28203
        • Carolinas HealthCare System, Carolinas Med. Ctr.
      • Greensboro, North Carolina, United States, 27401
        • Regional Center for Infectious Disease, Wendover Medical Center CRS
      • Raleigh, North Carolina, United States, 27610
        • Wake County Health and Human Services CRS
    • Ohio
      • Cincinnati, Ohio, United States
        • Univ. of Cincinnati CRS
      • Cleveland, Ohio, United States, 44106
        • Case CRS
      • Cleveland, Ohio, United States
        • MetroHealth CRS
      • Columbus, Ohio, United States, 432101228
        • The Ohio State Univ. AIDS CRS
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hosp. of the Univ. of Pennsylvania CRS
    • Washington
      • Seattle, Washington, United States, 981224304
        • University of Washington AIDS CRS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Concurrent Medication: Strongly recommended:

  • Pyrimethamine (50 mg) and folinic acid (15 mg) weekly in patients receiving dapsone who have CD4 count < 100 cells/mm3 and are toxoplasmosis seropositive.

Patients must have:

  • Working diagnosis of HIV infection.
  • CD4 count <= 200 cells/mm3 or <= 15 percent of total lymphocyte count at any time in the past OR a history of PCP.
  • History of intolerance of trimethoprim and/or sulfonamides that required permanent discontinuation.

NOTE:

  • Pregnant patients are eligible at the clinician's discretion.

Prior Medication:

Allowed:

  • Prior PCP prophylaxis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Active pneumocystosis.

Concurrent Medication:

Excluded:

  • PCP prophylaxis (other than study drug) or any medication with potential anti-PCP activity.

Patients with the following prior conditions are excluded:

  • Known treatment-limiting reaction to dapsone or atovaquone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: PARALLEL

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (ACTUAL)

July 1, 1997

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (ESTIMATE)

August 31, 2001

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG 277
  • CPCRA 034
  • 11253 (REGISTRY: DAIDS-ES)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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