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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001996
Other study ID # 053B
Secondary ID 05
Status Completed
Phase Phase 2
First received November 2, 1999
Last updated June 23, 2005

Study information

Verified date May 1992
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility 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.

Study Design

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


Intervention

Drug:
Atovaquone

Pentamidine isethionate


Locations

Country Name City State
United States Infectious Disease Research Consortium of Georgia Atlanta Georgia
United States East Bay AIDS Ctr Berkeley California
United States Boston City Hosp Boston Massachusetts
United States Massachusetts Gen Hosp Boston Massachusetts
United States Univ of Cincinnati Cincinnati Ohio
United States Kaiser Foundation Hosp Harbor City California
United States Baylor College of Medicine Houston Texas
United States Gathe, Joseph, M.D. Houston Texas
United States Cedars Sinai Med Ctr Los Angeles California
United States UCLA CARE Ctr Los Angeles California
United States Regional Med Ctr at Memphis Memphis Tennessee
United States Beth Israel Med Ctr New York New York
United States Harlem AIDS Treatment Group / Harlem Hosp Ctr New York New York
United States Saint Vincent's Hosp and Med Ctr New York New York
United States UCI Med Ctr Orange California
United States Buckley Braffman Stern Med Associates Philadelphia Pennsylvania
United States Portland Veterans Adm Med Ctr / Rsch & Education Grp Portland Oregon
United States AIDS Community Research Consortium Redwood City California
United States Davies Med Ctr San Francisco California
United States Dr Patrick Joseph San Ramone California

Sponsors (1)

Lead Sponsor Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States, 

References & 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)

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