Completed

Phase 3
Age: 13Years +
All Genders
ID00000802

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04

700

Participants Needed

44

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 44 locations

1

Alabama Therapeutics CRS

Birmingham, Alabama, United States, 35294

Status Unknown

2

USC CRS

Los Angeles, California, United States, 900331079

Status Unknown

3

Stanford CRS

Palo Alto, California, United States, 943055107

Status Unknown

4

Ucsd, Avrc Crs

San Diego, California, United States, 921036325

Status Unknown

5

Ucsf Aids Crs

San Francisco, California, United States, 941102859

Status Unknown

6

Santa Clara Valley Med. Ctr.

San Jose, California, United States, 951282699

Status Unknown

7

San Mateo County AIDS Program

San Mateo, California, United States

Status Unknown

8

Harbor-UCLA Med. Ctr. CRS

Torrance, California, United States, 90502

Status Unknown

9

University of Colorado Hospital CRS

Aurora, Colorado, United States, 80262

Status Unknown

10

Howard University Hosp., Div. of Infectious Diseases, ACTU

Washington D.C., District of Columbia, United States, 20059

Status Unknown

11

Univ. of Miami AIDS CRS

Miami, Florida, United States, 331361013

Status Unknown

12

Emory Univ. Hemophilia Program Office

Atlanta, Georgia, United States, 303652225

Status Unknown

13

Queens Med. Ctr.

Honolulu, Hawaii, United States, 96816

Status Unknown

14

Univ. of Hawaii at Manoa, Leahi Hosp.

Honolulu, Hawaii, United States, 96816

Status Unknown

15

Northwestern University CRS

Chicago, Illinois, United States, 60611

Status Unknown

16

Cook County Hosp. CORE Ctr.

Chicago, Illinois, United States, 60612

Status Unknown

17

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, United States, 60612

Status Unknown

18

Weiss Memorial Hosp.

Chicago, Illinois, United States, 60640

Status Unknown

19

Indiana Univ. School of Medicine, Infectious Disease Research Clinic

Indianapolis, Indiana, United States, 462025250

Status Unknown

20

Univ. of Iowa Healthcare, Div. of Infectious Diseases

Iowa City, Iowa, United States, 52242

Status Unknown

21

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States, 21287

Status Unknown

22

Bmc Actg Crs

Boston, Massachusetts, United States, 02118

Status Unknown

23

Beth Israel Deaconess - East Campus A0102 CRS

Boston, Massachusetts, United States, 02215

Status Unknown

24

Massachusetts General Hospital ACTG CRS

Boston, Massachusetts, United States

Status Unknown

25

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

Minneapolis, Minnesota, United States, 55415

Status Unknown

26

University of Minnesota, ACTU

Minneapolis, Minnesota, United States, 55455

Status Unknown

27

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, United States

Status Unknown

28

Washington U CRS

St Louis, Missouri, United States

Status Unknown

29

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

Omaha, Nebraska, United States

Status Unknown

30

SUNY - Buffalo, Erie County Medical Ctr.

Buffalo, New York, United States, 13210

Status Unknown

31

Beth Israel Med. Ctr. (Mt. Sinai)

New York, New York, United States

Status Unknown

32

NY Univ. HIV/AIDS CRS

New York, New York, United States

Status Unknown

33

Univ. of Rochester ACTG CRS

Rochester, New York, United States, 14642

Status Unknown

34

Unc Aids Crs

Chapel Hill, North Carolina, United States

Status Unknown

35

Carolinas HealthCare System, Carolinas Med. Ctr.

Charlotte, North Carolina, United States, 28203

Status Unknown

36

Regional Center for Infectious Disease, Wendover Medical Center CRS

Greensboro, North Carolina, United States, 27401

Status Unknown

37

Wake County Health and Human Services CRS

Raleigh, North Carolina, United States, 27610

Status Unknown

38

Univ. of Cincinnati CRS

Cincinnati, Ohio, United States

Status Unknown

39

Case CRS

Cleveland, Ohio, United States, 44106

Status Unknown

40

MetroHealth CRS

Cleveland, Ohio, United States

Status Unknown

41

The Ohio State Univ. AIDS CRS

Columbus, Ohio, United States, 432101228

Status Unknown

42

Hosp. of the Univ. of Pennsylvania CRS

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

43

University of Washington AIDS CRS

Seattle, Washington, United States, 981224304

Status Unknown

44

Mbeya Med. Research Program, Mbeya Referral Hosp. CRS

Mbeya, Tanzania

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Atovaquone compared with dapsone for the prevention of Pneumocystis carinii pneumonia in patients with HIV infection who cannot tolerate trimethoprim, sulfonamides, or both. Community Program for Clinical Research on AIDS and the AIDS Clinical Trials Group.

W M El-Sadr, R L Murphy, T M Yurik...

https://pubmed.ncbi.nlm.nih.gov/9862944