Screening HIV-Infected Patients for Vaccine Studies

Completed

Conditions studied: HIV Infection

In brief

This screening study will evaluate potential study volunteers with HIV infection to see if they are suitable candidates for trials of experimental vaccines against HIV (therapeutic), and against other infections (preventive). * Preventive vaccines against other infections. Preventive vaccines prevent a person from getting a disease. Preventive vaccines have been developed for many diseases, including, for example, whooping cough, measles, mumps, influenza, and hepatitis B. Some preventive vaccines may also prevent a disease from taking hold if given immediately after infection, such as vaccines for rabies, smallpox and hepatitis. * Therapeutic vaccines against HIV. Therapeutic vaccines are intended to treat someone who has already been infected, with the goal of controlling the disease or preventing it from causing severe illness. As yet, there are no therapeutic vaccines for any diseases. * Vaccines against other infections. Vaccines to prevent other infections besides HIV may need to be tested separately in people with HIV infection because the immune system works differently when HIV infection is present. HIV-infected patients 18 years of age or older may be eligible for this screening study. Women who are pregnant or breast feeding may not participate. Participants will be screened with the following: * A health history, including questions about sexual activity and drug use; * Physical examination, including blood and urine tests; * HIV testing to confirm HIV infection; * Pregnancy test for premenopausal women; * PPD test for tuberculosis for those who have not been tested in the previous 6 months. Candidates who meet the requirements for investigational vaccine studies will be invited to participate in a study. Those who do not begin a study within 1 month of the screening tests may need to repeat some tests for continued consideration. In addition, some studies require repeated measures of CD4 counts and viral load over a period of a few months.

Key facts

Study ID

NCT00051519

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

1000

Starts

2003-01-09

Expected to finish

2007-12-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Women who are known to be pregnant or breast feeding
• Clinically significant medical history, physical examination or laboratory test results that preclude participation in a clinical trial.
• A condition requiring medication that affects the immune response to a vaccine such as oral and parenteral corticosteroids, hydroxyurea, interleukin-2 or other immune modulators.
• A condition in which repeated blood draws or injections poses more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access.
• A condition that requires active medical intervention or monitoring to avert serious danger to the participant's health or well-being
• A condition in which signs or symptoms could be confused with reactions to vaccine
• Active participation in other experimental treatment studies

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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