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
Completed · Phase 3
Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00000802
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 700
- Expected to finish
- 1997-07-01
- Last updated by the study team
- 2021-11-04
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Alabama Therapeutics CRS — Birmingham, Alabama, United States
- USC CRS — Los Angeles, California, United States
- Stanford CRS — Palo Alto, California, United States
- Ucsd, Avrc Crs — San Diego, 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
- Howard University Hosp., Div. of Infectious Diseases, ACTU — Washington D.C., District of Columbia, United States
- Univ. of Miami AIDS CRS — Miami, Florida, United States
- Emory Univ. Hemophilia Program Office — Atlanta, Georgia, United States
- Queens Med. Ctr. — Honolulu, Hawaii, United States
- Univ. of Hawaii at Manoa, Leahi Hosp. — Honolulu, Hawaii, United States
- Northwestern University CRS — Chicago, Illinois, United States
- Cook County Hosp. CORE Ctr. — Chicago, Illinois, United States
- Rush Univ. Med. Ctr. ACTG CRS — Chicago, Illinois, United States
- Weiss Memorial Hosp. — Chicago, Illinois, United States
- Indiana Univ. School of Medicine, Infectious Disease Research Clinic — Indianapolis, Indiana, United States
- Univ. of Iowa Healthcare, Div. of Infectious Diseases — Iowa City, Iowa, United States
- Johns Hopkins Adult AIDS CRS — Baltimore, Maryland, United States
- Bmc Actg Crs — Boston, Massachusetts, United States
- Beth Israel Deaconess - East Campus A0102 CRS — Boston, Massachusetts, United States
- Massachusetts General Hospital ACTG CRS — Boston, Massachusetts, United States
- Hennepin County Med. Ctr., Div. of Infectious Diseases — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.