NIH Clinical Research Studies

Protocol Number: 03-I-0079

Active Accrual, Protocols Recruiting New Patients

Title:
Screening HIV-Infected Subjects for Vaccine Research Studies
Number:
03-I-0079
Summary:
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.

Sponsoring Institute:
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled
Gender: Male & Female
Referral Letter Required: No
Population Exclusion(s): Children

Eligibility Criteria:
INCLUSION CRITERIA:

Age 18 years or older

HIV-infected, confirmed by ELISA and Western blot

Willing to participate for the planned duration of the study (6 months or longer)

Able and willing to give informed consent

Agree to have blood stored for future studies related to HIV, the immune system, vaccine response and/or other medical conditions

EXCLUSION CRITERIA:

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

Special Instructions:
Currently Not Provided
Keywords:
HIV
AIDS
Vaccine
HIV-positive
Therapy
Recruitment Keyword(s):
None
Condition(s):
HIV Infection
Investigational Drug(s):
None
Investigational Device(s):
None
Intervention(s):
None
Supporting Site:
National Institute of Allergy and Infectious Diseases

Contact(s):
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s): Not Provided

Active Accrual, Protocols Recruiting New Patients

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