A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

Completed · Phase 2

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.

Key facts

Study ID

NCT00000655

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

300

Last updated by the study team

2011-03-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient must have the following:
• Presumptive diagnosis of AIDS as defined by the CDC.
• Untreated Pneumocystis carinii pneumonia (PCP).
• Willingness and ability to give informed consent.
• Prior Medication:
• Allowed:
• Prophylactic therapy for Pneumocystis carinii pneumonia (PCP) including aerosolized pentamidine or sulfamethoxazole/trimethoprim (SMX/TMP) (at a dose no greater than two DS tablets twice daily).

You may not qualify if…

• Co-existing Condition:
• Patients with the following conditions or symptoms are excluded:
• Judged by the investigator to be in impending respiratory failure.
• Malabsorption or vomiting that would, in the judgment of investigator, potentially limit the retention and absorption of an oral therapy.
• Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult.
• Concurrent Medication:
• Excluded:
• Corticosteroid treatment (except replacement therapy or patients in Group B).
• Ganciclovir.
• Zidovudine (AZT).
• Investigational agents including antiretroviral agents (didanosine (ddI), dideoxycytidine (ddC), etc.).
• Drugs likely to have anti-pneumocystis effect such as:
• Sulfonamides.
• Pentamidine.
• Dapsone.
• Trimethoprim.
• Other DHFR inhibitors.
• Primaquine.
• Clindamycin.
• Sulfonylureas.
• Patients with the following are excluded:
• Judged by the investigator to be in impending respiratory failure.
• Prior therapy for this episode of PCP or treatment within 4 weeks of entry for a prior episode of PCP.
• Unable to or refuse to discontinue zidovudine, ganciclovir, or other antiretroviral agents during the 21 day treatment period.
• Unable to take medication orally or unwilling or unable to take study medication with food.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Kaiser Foundation Hosp — Harbor City, California, United States
• USC — Los Angeles, California, United States
• Dr Richard Meyer — Los Angeles, California, United States
• UCLA CARE Ctr — Los Angeles, California, United States
• Infectious Disease Med Group — Oakland, California, United States
• Univ of California / San Diego Treatment Ctr — San Diego, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• UCSF - San Francisco Gen Hosp — San Francisco, California, United States
• Dr Marcus Conant — San Francisco, California, United States
• Georgetown Univ Med Ctr — Washington D.C., District of Columbia, United States
• Veterans Administration Med Ctr — Washington D.C., District of Columbia, United States
• Dr Winkler Weinberg — Roswell, Georgia, United States
• Johns Hopkins Univ School of Medicine — Baltimore, Maryland, United States
• Natl Inst of Allergy & Infect Dis / Cln Ctr — Bethesda, Maryland, United States
• Washington Univ School of Medicine — St Louis, Missouri, United States
• Beth Israel Med Ctr / Peter Krueger Clinic — New York, New York, United States
• Saint Vincent's Hosp and Med Ctr — New York, New York, United States
• Harlem AIDS Treatment Group / Harlem Hosp Ctr — New York, New York, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Univ of Cincinnati — Cincinnati, Ohio, United States
• Good Samaritan Hosp — Portland, Oregon, United States
• Buckley Braffman Stern Med Associates — Philadelphia, Pennsylvania, United States
• Regional Med Ctr at Memphis — Memphis, Tennessee, United States
• The Regional Medical Ctr, Memphis — Memphis, Tennessee, 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.