DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections

Intervention: Atovaquone (Drug); Pentamidine isethionate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Glaxo Wellcome

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.

Clinical Details

Official title: 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

Study design: Endpoint Classification: Safety Study, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Minimum age: 13 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria 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.

Exclusion Criteria 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).

Patients with the following are excluded:

- Judged by the investigator to be in impending respiratory failure.

- Known intolerance to parenteral pentamidine isethionate, or therapeutic failure with

same for treatment of current episode of PCP.

- Significant psychosis or emotional disorder that, in the investigator's opinion,

would preclude the patient from adhering to the protocol.

- Inability or unwillingness to take medication orally or with food.

- Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency.

- History, or present occurrences, of abnormal prolongation of QT interval on standard,

12 lead EKG.

- Termination from FDA 053A due to toxicity.

- For patients entering under historic intolerance criteria (Groups A and B), prior

therapy for this episode of PCP is an exclusion. Prior Medication: Excluded:

- Treatment within 4 weeks of entry for a prior episode of PCP.

- For patients entering under historic intolerance criteria (Groups A and B), prior

therapy for this episode of PCP is an exclusion. Required:

- Adjuvant prednisone for patient enrolled in Strata B or D.

Locations and Contacts

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

Boston City Hosp, Boston, Massachusetts 02118, United States

Massachusetts Gen Hosp, Boston, Massachusetts 02114, United States

Beth Israel Med Ctr, New York, New York 10003, United States

Harlem AIDS Treatment Group / Harlem Hosp Ctr, New York, New York 10037, United States

Saint Vincent's Hosp and Med Ctr, New York, New York 10011, 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

Baylor College of Medicine, Houston, Texas 77030, United States

Gathe, Joseph, M.D., Houston, Texas 77004, United States

Additional Information

Related publications:

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)


Last updated: June 23, 2005

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017