Screening HIV-Infected Patients for Vaccine Studies
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2003 |
| End Date: | December 2007 |
Screening HIV-Infected Subjects for Vaccine Research Studies
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.
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.
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.
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.
- 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
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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