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Home > "A" Clinical Trials Conditions > A Study of WR 6026 in the Treatment of Pneumocystis carinii Pneumonia (PCP) in HIV-Infected Patients

A Study of WR 6026 in the Treatment of Pneumocystis carinii Pneumonia (PCP) in HIV-Infected Patients



A Study of WR 6026 in the Treatment of Pneumocystis carinii Pneumonia (PCP) in HIV-Infected Patients

For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the efficacy of WR 6026 once daily in the treatment of mild PCP. To evaluate the safety and tolerance of WR 6026. To assess the correlation between plasma WR 6026 concentrations and outcome/toxicity.
Details: All patients will receive an initial loading dose of WR 6026, followed the next morning and each morning thereafter by 1 of 2 lower doses of WR 6026 taken in a fasting state for 3 weeks.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Any medications not listed as excluded will be permitted on study. [ AS PER AMENDMENT 4/11/97:PCP prophylaxis is permitted if initiated after the Day 21 evaluation has been completed.] Patients must have: - Documented HIV infection. - Documented PCP. - On a room air ABG, the PO2 value greater than or equal to 70 mm Hg and the (A-a) DO2 less than 35 mm Hg. - Signed informed consent from parent or legal guardian for those patients less than 18 years of age. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Known hypersensitivity to quinolines. - If patient is unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study. Concurrent Medication: Excluded: - Any patient unwilling or unable to discontinue other medications with anti-PCP activity during the treatment period of this study (e.g., TMP/SMX, sulfonamides, dapsone, pentamidine, trimetrexate, atovaquone, clindamycin, azithromycin, pyrimethamine, primaquine). - Methemoglobinemia-producing agents (dapsone, primaquine, sulfonamides, chloroquine, nitrofurantoin, nitrates and nitrites). Patients with the following prior conditions or symptoms are excluded: - History of G6PD deficiency, hemoglobin M abnormality, or NAD methemoglobin reductase deficiency. Prior Medication: Excluded: - More than 24 hours receipt of anti-PCP treatment for the current episode of PCP. Receipt of prior PCP prophylaxis is permitted, as long as it is discontinued at study entry.
Total Enrollment: 45

Location and Contact Information:

Overall Study Official:
DohnM,  Study Chair, 

Methodist Hosp of Indiana / Life Care Clinic
Indianapolis,  Indiana,  46202
United States
 

Bellevue Hosp / New York Univ Med Ctr
New York City,  New York,  10016
United States
 

Louis A Weiss Memorial Hosp
Chicago,  Illinois,  60640
United States
 

Ohio State Univ Hosp Clinic
Columbus,  Ohio,  432101228
United States
 

Univ of Hawaii
Honolulu,  Hawaii,  96816
United States
 

SUNY / Erie County Med Ctr at Buffalo
Buffalo,  New York,  14215
United States
 

Univ of Southern California / LA County USC Med Ctr
Los Angeles,  California,  900331079
United States
 

Univ of Washington
Seattle,  Washington,  981224304
United States
 

Queens Med Ctr
Honolulu,  Hawaii,  96816
United States
 

Univ of Cincinnati
Cincinnati,  Ohio,  452670405
United States
 

Univ of Alabama at Birmingham
Birmingham,  Alabama,  35294
United States
 

Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis,  Indiana,  46202
United States
 

Northwestern Univ Med School
Chicago,  Illinois,  60611
United States
 

Indiana Univ Hosp
Indianapolis,  Indiana,  462025250
United States
 

Univ of Rochester Medical Center
Rochester,  New York,  14642
United States
 

Johns Hopkins Hosp
Baltimore,  Maryland,  21287
United States
 


Additional Information:
Study ID Numbers:
  ACTG 314; 
Study Start Date: 
Record last reviewed: May 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000863

Other Hiv Infections Studies:
1. 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. A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS

3. Gradual Initiation of Sulfamethoxazole/Trimethoprim as Primary Pneumocystis carinii Pneumonia Prophylaxis

4. Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis carinii Pneumonia

5. A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis carinii Pneumonia in Patients With AIDS Post First Episode PCP

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