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Home > "H" Clinical Trials Conditions > HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs  HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs
HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: This study will evaluate the safety of and immune responses to a dendritic cell vaccination for HIV-1 infection. The vaccine will be made from a patient's own cells combined with small fragments of HIV-1 (made synthetically in a laboratory). These cells will be administered back to the patient either into a vein (intravenously) or the skin (subcutaneously).
Details: Untreated HIV-1 infection is characterized by progressive immune dysfunction and the development of opportunistic infections and AIDS-associated malignancies. Highly active antiretroviral therapy (HAART) has been successful in suppressing HIV replication and restoring partial immune function. However, HIV-specific immunity remains poor, as evidenced by rapid rebound of HIV-1 RNA following HAART withdrawal. Studies of individuals with acute HIV-1 infection, as well as those who are long-term nonprogressors, have suggested that robust HIV-specific immune responses are associated with control of HIV-1 viremia. Dendritic cells (DCs) are potent antigen presenting cells that may increase HIV-specific immune responses. This protocol will evaluate the use of DCs to help control HIV infection. Patients will be randomized to receive either intravenous or subcutaneous administration of HIV antigen expressing DCs. Each subject will receive two administrations of mature DCs given 3 weeks apart. Subjects will be followed weekly for 8 weeks, then at Weeks 12, 16, 24, 36, and 48. Two doses of DCs will be evaluated (low dose: 1-3 million cells; high dose: 5-10 million cells) for safety and immune system response.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - HIV-1 infection - Current CD4 > 400/mm3 - HIV RNA < 400 copies/ml - Stable combination antiretroviral therapy for at least 4 weeks prior to study entry - HLA A2.1 (to be tested at screening) Exclusion criteria - Prior HIV vaccine - Systemic steroids or immunosuppressive drugs within 30 days of study entry - Pregnant or breastfeeding
Total Enrollment: 18
Location and Contact Information:
Overall Study Official:
SharonRiddler, Principal Investigator, University of Pittsburgh
University of Pittsburgh, Pitt Treatment Evaluation Unit *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Carol Oriss 412-647-8125, 1-888-396-7838
Additional Information:
Study ID Numbers: P01 AI43664-04;
Study Start Date: February 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056758
Other Hiv Infections Studies:
1. A phase II study of lopinavir/ritonavir in combination with saquinavir mesylate or lamivudine/zidovudine to explore metabolic toxicities in antiretroviral HIV-infected subjects
2. Metabolic Abnormalities in HIV Infected and Uninfected Young Women
3. An Escalating Dose Tolerance Trial of BG8962 (rCD4) in Patients Who Are HIV Antibody Positive
4. Randomized Placebo-Controlled Study of Aerobic Exercise and Resistance Training Plus Megestrol Acetate for HIV-Wasting
5. Safety of and Immune Response to a Combination HIV Vaccine Regimen in HIV Uninfected Adults
Related Studies:
Other HIV Infections Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs
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