Clinical Trials

PHS 398/2590

Sponsor:
NIH

Study Title:
Serum Antibodies to Recombinant Pneumocystis Antigens

Summary:
OPEN TO ENROLLMENT. This study will produce the first information about the global serologic antibody response to Pneumocystis using a standard set of antigens; distinguish epitopes that are associated with recovery from those that are not; and provide new information about the responses to Pneumocystis in the normal host. Information gained from this grant will enhance the understanding of the immunology and epidemiology of Pneumocystis infection in humans, lead to a simple serologic test, and stimulate new approaches to the treatment and prevention of PcP.

Phase:
Observational

Study Design:
International, multicenter, prospective, non-randomized single-arm, observational, non-interventional cohort study.

HIV-infected subjects:  A total of 110 HIV-infected adult patients will be identified through review of clinic- based records and enrolled at the participating study sites. 35 patients with a history of PcP (PcP+) as determined by microscopic analysis or a presumptive diagnosis will be included at each site. The diagnosis of PcP must have been made ≥3 months previously in order to allow for accurate measurement of antibody level. 75 HIV-infected patients Without a known history of PeP (PcP-) will also be enrolled.  Patients will be divided into PcP+ and PcP- based on medical chart review as below, and if possible, subject interview.  Patients will be eligible for enrollment regardless of use of HAART, CD4 cell count, or HIV viral level.

Control subjects: Control subjects will be 110 non-HIV-infected subjects from each site. In 13 sites, these subjects will be anonymous blood donors who have tested negative for HIV.

Eligibility Criteria:
Inclusion criteria:

• Age ≥18 years old and
• Documented HIV infection.

• Patients with acute pneumonia, cough, shortness of breath, fevers, or a history of PcP within the past 3 months.
• Subjects who are unable or unwilling to provide informed consent will also be excluded.

Drugs/Treatment Provided:
None

Compensation:
None

Study Duration: One visit.

Principal Investigator: Donna Mildvan, M.D.

Study Location: Beth Israel Medical Center

Infectious Diseases/AIDS Clinical Trials Unit

350 East 17th Street, 3rd floor

New York, NY, 10003

Contact Information: Phone: 212-420-4519 or 800-483-7339 Email

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PHS 398/2590
Serum Antibodies to Recombinant Pneumocystis Antigens

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