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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. A Randomized Phase III Clinical Trial of Daunoxome Versus Combination Chemotherapy With Adriamycin/Bleomycin/Vincristine (ABV) in the Treatment of HIV-Associated Kaposi's Sarcoma.
2. Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma
3. A Phase I/II Open-Labelled Trial of Intravitreal Ganciclovir Salvage Therapy for AIDS Patients With Active CMV Retinitis Who Are Intolerant of Systemic Therapy
4. A Comparison of Atovaquone and Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia in HIV-Infected Patients Who Cannot Take TMP/SMX
5. Study of Itraconazole in Patients with Advanced HIV Infection
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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