|
Screening HIV-Infected Patients for Vaccine Studies Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Screening HIV-Infected Patients for Vaccine Studies conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Screening HIV-Infected Patients for Vaccine Studies Clinical research trials and Screening HIV-Infected Patients for Vaccine Studies medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Screening HIV-Infected Patients for Vaccine Studies. Screening HIV-Infected Patients for Vaccine Studies Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Screening HIV-Infected Patients for Vaccine Studies clinical trial. Subjects typically recieve the finest healthcare available for their Screening HIV-Infected Patients for Vaccine Studies condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Screening HIV-Infected Patients for Vaccine Studies  Screening HIV-Infected Patients for Vaccine Studies
Screening HIV-Infected Patients for Vaccine Studies
For Condition: HIV Infection
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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 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, ANA/anti-dsDNA, quantitative IgG, adenovirus serology and T cell subsets (CD4/CD8). Blood will also be collected for storage. A PPD will be administered unless subject has documentation of a negative PPD within six months prior to enrollment.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 100
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 030079; 03-I-0079
Study Start Date: January 9, 2003
Record last reviewed: October 2, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00051519
Other Hiv Infection Studies:
1. Combination Therapy with IL-2 Plus Antiretroviral Drugs to Treat HIV Infection
2. Immune and Viral Status of HIV-Infected Patients after Stopping Combination Antiretroviral Therapy
3. Magnetic Resonance Imaging of the Face and Bones
4. Influenza Vaccine in HIV Infection: Immune Response and Effect on Viral Load
5. Combination Drug Treatment of Pediatric HIV Infection
Related Studies:
Other HIV Infection Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Screening HIV-Infected Patients for Vaccine Studies
|
|
|
|
|
|
|
|
