A Pilot Study of a Dendritic Cell Vaccine in HIV-1 Infected Subjects - Full Text View

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00833781

Purpose

The purpose of the study is to find out whether an experimental autologous dendritic cell vaccine is safe, well tolerated, and whether it can strengthen the immune system's response to HIV.

Condition	Intervention	Phase
HIV-1 Infection HIV Infections	Biological: mRNA-transfected autologous dendritic cells Biological: Autologous dendritic cells not transfected with mRNA.	Phase I Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Pilot, Double-blind, Placebo-controlled, Randomized Clinical Trial of mRNA-transfected Autologous Dendritic Cells in Subjects With Well-controlled Chronic HIV-1 Infection on Highly Active Antiretroviral Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

The safety and tolerability of mRNA-transfected autologous dendritic cell vaccine. [ Time Frame: After each vaccination. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Immune response to the vaccine. [ Time Frame: Week 4 and after the final vaccination. ] [ Designated as safety issue: No ]

Estimated Enrollment:	21
Study Start Date:	August 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 mRNA-transfected autologous dendritic cell vaccine.	Biological: mRNA-transfected autologous dendritic cells Injections will be administered intradermally at weeks 0, 2, 6 and 10.
Placebo Comparator: 2 Dendritic cell vaccine without transfected mRNA.	Biological: Autologous dendritic cells not transfected with mRNA. Injections will be administered intradermally at weeks 0, 2, 6 and 10.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV-1 positive
CD4+ T Cell count >200
Undetectable HIV viral load for 6 months prior to screening
On antiretroviral treatment for 12 months prior to screening

Exclusion Criteria:

Hepatitis C positive
Detectable HIV viral load within 6 months prior to study entry
Females who are pregnant or nursing

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833781

Contacts

Contact: Douglas Kwon, MD, PhD	617-726-4748	dkwon@partners.org
Contact: Theresa Flynn, RN, MSN, ANP	617-726-3819	tflynn@partners.org

Locations

United States, Massachusetts
Infectious Disease Unit; Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Rajesh Gandhi, MD

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Rajesh Gandhi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00833781 History of Changes
Other Study ID Numbers:	2008p001577, R01-AI066992-04, DAIDS-ES ID 10731
Study First Received:	January 29, 2009
Last Updated:	April 30, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

HIV vaccine
Dendritic cells
treatment experienced

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases

Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on February 09, 2012