Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051519
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-01-10
Brief Title:
Screening HIV-Infected Patients for Vaccine Studies
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Screening HIV-Infected Subjects for Vaccine Research Studies
Status:
COMPLETED
Status Verified Date:
2009-06-25
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
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 1000 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 andor 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 PTPTT 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 CD4CD8 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
Subjects Approximately 1000 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 andor 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 PTPTT 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 CD4CD8 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-I-0079 | None | None | None |