Status:

COMPLETED

The Use of Bacteriophage Phi X174 to Assess the Immune Competence of HIV-Infected Patients In Vivo

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

Brief Summary

The objective of this study is to evaluate the safety and utility of bacteriophage phi X174 immunization as a tool to assess the immune competence of HIV-infected patients at different stages of disea...

Detailed Description

The objective of this study is to evaluate the safety and utility of bacteriophage phi X174 immunization as a tool to assess the immune competence of HIV-infected patients at different stages of disea...

Eligibility Criteria

Male or female; 18 years of age and over.

Women of child bearing potential must have a negative pregnancy test 2 weeks prior to immunization and must agree to use an active form of birth control during participation. Men should exercise appropriate contraceptive measures while participating on the study.

Ability and willingness to sign an informed consent.

Adequate venous access as assessed by the Principal or Associate Investigators.

Willingness to comply with the protocol requirements and visit schedule.

HIV-INFECTED PATIENTS:

HIV seropositivity on Elisa, confirmed with Western Blot.

No use or a stable use of an FDA-approved antiviral drug regimen for at least one month.

Life expectancy greater than 6 months.

NORMAL VOLUNTEERS:

Healthy (all clinical and laboratory tests should be in the normal range).

HIV seronegativity.

No signs and/or other laboratory evidence of immunodeficiency. These include a history of persistent or recurrent infections, infections with unusual organisms or autoimmunity.

No prior immunization with bacteriophage phi X 174.

No current active opportunistic infection.

No use of immune -based therapies or other experimental agents, corticosteroids (at doses greater than 25 mg/d of prednisone for more than 4 weeks) or any other immunosuppressive drugs within 6 months prior to enrollment.

No history of severe asthma defined by the need for intermittent or continuous corticosteroid therapy.

Key Trial Info

Start Date :

April 1 1996

Trial Type :

OBSERVATIONAL

End Date :

March 1 2000

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT00001540

Start Date

April 1 1996

End Date

March 1 2000

Last Update

March 4 2008

Active Locations (1)

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1

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, Maryland, United States, 20892