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

HIV Infections Clinical Trial

Official title:

A Phase II Study of WR 6026 for Pneumocystis Carinii Pneumonia in People With HIV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000863
• Other study ID #: ACTG 314
• Secondary ID: 11289
• Status: Completed
• Phase: Phase 2
• Est. completion date: July 1998

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 1998
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Infections
• Pneumonia
• Pneumonia, Pneumocystis
• Pneumonia, Pneumocystis Carinii

Intervention

Drug:
• Sitamaquine

Locations

Country	Name	City	State
United States	Alabama Therapeutics CRS	Birmingham	Alabama
United States	SUNY - Buffalo, Erie County Medical Ctr.	Buffalo	New York
United States	Northwestern University CRS	Chicago	Illinois
United States	Weiss Memorial Hosp.	Chicago	Illinois
United States	Univ. of Cincinnati CRS	Cincinnati	Ohio
United States	The Ohio State Univ. AIDS CRS	Columbus	Ohio
United States	Queens Med. Ctr.	Honolulu	Hawaii
United States	Univ. of Hawaii at Manoa, Leahi Hosp.	Honolulu	Hawaii
United States	Indiana Univ. School of Medicine, Infectious Disease Research Clinic	Indianapolis	Indiana
United States	Indiana Univ. School of Medicine, Wishard Memorial	Indianapolis	Indiana
United States	Methodist Hosp. of Indiana	Indianapolis	Indiana
United States	NY Univ. HIV/AIDS CRS	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)