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Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients Clinical research trials and Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients. Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients clinical trial. Participants oftentimes recieve the finest healthcare available for their Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients  Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients
Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The aim of this trial is to find out if immune responses to HIV can be boosted in individuals who start medicines soon after being infected. If immune responses can be boosted to the virus, this may allow the body to control HIV without the need for medications. This study is designed to test a new strategy for boosting immune responses to HIV and to evaluate if these responses allow people to have control of HIV without medicines.
Details: The novel strategy used in this trial is to mix a peptide vaccine with dendritic cells from individuals. The dendritic cells are normal cells in the blood that boost immune responses. In HIV uninfected people, dendritic cells have been found to strongly activate the types of immune responses that may be important in controlling HIV. HIV infected and HIV uninfected individuals in this study will receive four monthly shots of dendritic cells plus vaccine. We will monitor the immune responses to the peptide vaccine during this time period. After completing the vaccinations, HIV infected patients will stop their HIV medications and their immune status (CD4 count) and viral load will be monitored closely over 12 weeks.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Both HIV infected and HIV uninfected individuals are eligible for this study. - CD4 cell count of 400 cells/mm3 or greater at study entry - If HIV infected, initiated anti-HIV medicines within 120 days of infection - If HIV infected, HIV viral load < 50 copies/ml for at least 3 months prior to study entry - Current medication regimen for at least 3 months prior to study entry - A particular blood type (HLA-A*0201) - Acceptable methods of contraception Exclusion Criteria - Received investigational drug or vaccine within 30 days prior to study entry - On other immune-based therapy (e.g., interleukin-2, alpha interferon, immunoglobulin, thalidomide) within 30 days prior to study entry - Megesterol acetate within 30 days prior to study entry - Immunization within 4 weeks of study entry - If hepatitis B virus (HBV) uninfected and at high risk for HBV infection, the patient will not be eligible until he or she has completed an HBV vaccine series. - Unstable or severe medical condition, including active opportunistic infection requiring treatment - History of Hashimoto's thyroiditis - Cancer requiring chemotherapy within 6 months prior to study entry - History of radiation therapy to axillary lymph nodes - Significant laboratory abnormalities at study entry - Pregnant or breastfeeding - History of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, scleroderma, mixed connective tissue disorder) - Allergy to gentamicin, tobramycin, streptomycin, or amikacin
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
NiniBhardwaj, Principal Investigator, New York University School of Medicine
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Rajesh Gandhi 617-724-9690
Additional Information:
Study ID Numbers: R01 AI44628;
Study Start Date: November 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058734
Other Hiv Infections Studies:
1. Vitamin B Therapy for Hyperlactatemia
2. A Phase I/II Study of Intralesional Recombinant Tumor Necrosis Factor in Patients With AIDS-Related Cutaneous Kaposi's Sarcoma
3. A Study to Test the Safety of Three Experimental HIV Vaccines
4. HIV Symptom Management Program for African American Mothers
5. A Study of HIV Levels During Pregnancy and After Childbirth
Related Studies:
Other HIV Infections Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients
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