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| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 10, 2003 |
| Last Updated Date | August 27, 2009 |
| Start Date ICMJE | January 2003 |
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE |
To determine the safety and tolerability of a combination of a fixed dose of vaccine and anti-CTLA4, which will be dose escalated. |
| Change History | Complete list of historical versions of study NCT00051519 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE |
To evaluate immunologic response (as measured by an increase in PSA specific T-cells measured by ELISPOT in HLA-A2+ patients), and clinical response (as measured by RECIST and PSA consensus criteria). |
| Descriptive Information | |
| Brief Title ICMJE | Screening HIV-Infected Patients for Vaccine Studies |
| Official Title ICMJE | Screening HIV-Infected Subjects for Vaccine Research Studies |
| 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).
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. |
| 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 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. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE | HIV Infection |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 1000 |
| Completion Date | December 2007 |
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE |
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 |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00051519 |
| Responsible Party | |
| Study ID Numbers ICMJE | 030079, 03-I-0079 |
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | June 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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