A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Who Are Intolerant of Trimethoprim / Sulfamethoxazole
2 other identifiers
interventional
N/A
1 country
20
Brief Summary
To compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the incidence of premature discontinuation of therapy due to toxicity. To compare the efficacy of 566C80 with intravenous (IV) pentamidine for the treatment of mild to moderate PCP in the same population.
Trial Health
Trial Health Score
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20 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
May 1, 1992
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have the following:
- History of, or are currently experiencing, intolerance to TMP / SMX, or to another sulfonamide, which required discontinuation of therapy.
- Pneumocystis carinii pneumonia (PCP).
- Willing and able to give informed consent.
You may not qualify if:
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded.
- Malabsorption disorder or vomiting that would, in the judgement of the 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.
- Present occurrences of abnormal prolongation of QT interval on standard, 12 lead EKG.
- Concurrent Medication:
- Excluded:
- Drugs with potential anti-pneumocystis effect (eg:
- sulfonamides, dapsone, trimethoprim, other dihydrofolate reductase (DHFR) inhibitors, primaquine, clindamycin, sulfonylureas).
- Ganciclovir.
- Zidovudine.
- Investigational agents including anti-retroviral agents (ddI, ddC, etc.). Patients receiving these drugs prior to entry must discontinue their use during the therapy phase (21 days) of the trial.
- Corticosteroids (except replacement therapy) during the 21 day treatment period (Strata A and C Patients).
- Class 1A antiarrhythmics (ie:
- quinidine, procainamide, disopyramide).
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Glaxo Wellcomelead
Study Sites (20)
East Bay AIDS Ctr
Berkeley, California, 94704, United States
Kaiser Foundation Hosp
Harbor City, California, 90710, United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
UCI Med Ctr
Orange, California, 92668, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
Davies Med Ctr
San Francisco, California, 94114, United States
Dr Patrick Joseph
San Ramone, California, 94583, United States
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, 30345, United States
Massachusetts Gen Hosp
Boston, Massachusetts, 02114, United States
Boston City Hosp
Boston, Massachusetts, 02118, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Saint Vincent's Hosp and Med Ctr
New York, New York, 10011, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, 10037, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, 97210, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103, United States
Gathe, Joseph, M.D.
Houston, Texas, 77004, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Related Publications (1)
Dohn M, Weinberg W, Rosenstock J, Follansbee S, Torres R, Caldwell P. Atovaquone vs. pentamidine for pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):372 (abstract no PO-B10-1421)
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1992-05