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

Tracking Information
First Submitted Date ICMJE	November 2, 1999
First Posted Date ICMJE	August 31, 2001
Last Update Posted Date	April 2, 2012
Study Start Date ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE	Not Provided
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00000863 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	A Study of WR 6026 in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients
Official Title ICMJE	A Phase II Study of WR 6026 for Pneumocystis Carinii Pneumonia in People With HIV Infection
Brief Summary	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.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Primary Purpose: Treatment
Condition ICMJE	Pneumonia, Pneumocystis Carinii; HIV Infections
Intervention ICMJE	Drug: Sitamaquine
Study Arms	Not Provided
Publications *	Petty B, Black J, Hendrix C, Bassiakos Y, Feinberg J, Hafner R. Escalating multiple-dose safety and tolerance of WR 6026 in HIV-infected subjects. Int Conf AIDS. 1993 Jun 6-11;9(1):498 (abstract no PO-B29-2180)
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 23, 2005)	45
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	July 1998
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	13 Years and older (Child, Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00000863
Other Study ID Numbers ICMJE	ACTG 314; 11289 ( Registry Identifier: DAIDS ES Registry Number )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	National Institute of Allergy and Infectious Diseases (NIAID)
Study Sponsor ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Chair: Dohn M Study Chair: Petty B Study Chair: Black J Study Chair: Frame P
PRS Account	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	March 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP