A Study of WR 6026 in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Patients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00000863 |
Recruitment Status
:
Completed
First Posted
: August 31, 2001
Last Update Posted
: April 2, 2012
|
Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
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 |
|
||||||||||||
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 |
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:
[ AS PER AMENDMENT 4/11/97:PCP prophylaxis is permitted if initiated after the Day 21 evaluation has been completed.] Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Concurrent Medication: Excluded:
Patients with the following prior conditions or symptoms are excluded:
Prior Medication: Excluded:
|
||||||||||||
Sex/Gender |
|
||||||||||||
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 |
|
||||||||||||
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 |