Screening HIV-Infected Patients for Vaccine Studies

NCT00051519 | Completed

• 2 other identifiers: 03007903-I-0079
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infection

Keywords

HIV; AIDS; Vaccine; HIV-positive; Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; HIV Seropositivity

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 10, 2003
• First Posted: January 13, 2003
• Study Start: January 9, 2003
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 2, 2017

Record last verified: 2009-06-25

Locations

US (1)