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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00051519 |
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).
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:
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.
Condition |
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HIV Infection |
Study Type: | Observational |
Official Title: | Screening HIV-Infected Subjects for Vaccine Research Studies |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2003 |
Study Design: The purpose of this protocol is to screen potential study volunteers with HIV infection to determine if they are suitable candidates for vaccine trials. Screening will be primarily for HIV vaccine trials, but may also be for screening HIV-infected adults to participate in trials of other kinds of vaccine studies that will be enrolling HIV-infected subjects. All work will be conducted at the National Institutes of Health. HIV-infected volunteers will be recruited and screened. This protocol will be used to determine if the volunteers meet eligibility requirements for participation in trials of vaccines in HIV-infected subjects.
Subjects: Approximately 1,000 adults with HIV infection.
Study Plan: Subjects are evaluated for eligibility to participate in a vaccine trial and receive counseling on HIV-related issues. Women receive counseling on avoidance of pregnancy during a clinical trial. If it is determined that the volunteer might be eligible for a vaccine trial, additional information about trial options will be provided by telephone, mail and/or visits with a study coordinator.
Study Duration: Approximately six months for each subject.
Study Evaluations: Evaluations usually include history and physical examinations and CBC, differential, platelets, PT/PTT, chemistry panel, urinalysis, pregnancy test for women of reproductive potential, hepatitis B surface antigen, hepatitis C antibody, RPR, ELISA and Western blot for HIV, anti-dsDNA, quantitative immunoglobulins, adenovirus serology and T cell subsets (CD4/CD8). However, only those evaluations needed to determine eligibility for a particular vaccine study will be completed. Blood will also be collected for storage. If needed for eligibility in a particular vaccine study, a PPD will be administered unless subject has documentation of a negative PPD within six months prior to enrollment. In addition, other standard clinical evaluations may be done if needed to determine eligibility for a particular vaccine study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
Contact: TTY | 1-866-411-1010 |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 |
Study ID Numbers: | 030079, 03-I-0079 |
Study First Received: | January 10, 2003 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00051519 History of Changes |
Health Authority: | United States: Federal Government |
HIV AIDS Vaccine HIV-positive Therapy |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Seropositivity HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |