Clinical trial NCT00056758: HIV Vaccine Designed for HIV Infected Adults Taking Anti-HIV Drugs
Official title: Randomized Phase I Evaluation of Immunization With Highly Conserved HIV-1 Derived Peptides and Influenza Matrix Peptide in HIV-1-Infected Subjects on Highly Active Antiretroviral Therapy (HAART) Using Autologous Dendritic Cells Derived From Adherent Monocytic Precursors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV-1
HAART
Therapeutic immunization
HIV Therapeutic Vaccine
Treatment Experienced
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2003-03-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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 criteria: Inclusion Criteria

* HIV-1 infection
* Current CD4 count more than 400/mm3
* HIV RNA less than 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

Primary outcomes:
measure: Safety and tolerability of peptide pulsed, autologous, cultured dendritic cells
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh, Pitt Treatment Evaluation Unit
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sharon A. Riddler, MD
role: PRINCIPAL_INVESTIGATOR
References: