Status:

COMPLETED

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

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Pneumonia, Pneumocystis Carinii

HIV Infections

Eligibility:

All Genders

13+ years

Phase:

PHASE3

Brief Summary

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 CD...

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 o...

Eligibility Criteria

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.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

July 1 1997

Estimated Enrollment :

700 Patients enrolled

Trial Details

Trial ID

NCT00000802

End Date

July 1 1997

Last Update

November 4 2021

Active Locations (44)

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Page 1 of 11 (44 locations)

1

Alabama Therapeutics CRS

Birmingham, Alabama, United States, 35294

2

USC CRS

Los Angeles, California, United States, 900331079

3

Stanford CRS

Palo Alto, California, United States, 943055107

4

Ucsd, Avrc Crs

San Diego, California, United States, 921036325

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 | DecenTrialz