search
Back to results

Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dendritic Cells Pulsed with HIV antigens
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Dendritic Cell, Immunotherapy, Acute HIV, Human Immunodeficiency Virus, AIDS, HIV Therapeutic Vaccine, Treatment Experienced, Treatment Interruption

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 11, 2003
Last Updated
August 23, 2007
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00058734
Brief Title
Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients
Official Title
Immune Responses to Antigen-Bearing Dendritic Cells in HIV-Infected Individuals
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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 one shot of dendritic cells alone followed by three 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Dendritic Cell, Immunotherapy, Acute HIV, Human Immunodeficiency Virus, AIDS, HIV Therapeutic Vaccine, Treatment Experienced, Treatment Interruption

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
Dendritic Cells Pulsed with HIV antigens

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nina Bhardwaj, MD, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10411546
Citation
Dhodapkar MV, Steinman RM, Sapp M, Desai H, Fossella C, Krasovsky J, Donahoe SM, Dunbar PR, Cerundolo V, Nixon DF, Bhardwaj N. Rapid generation of broad T-cell immunity in humans after a single injection of mature dendritic cells. J Clin Invest. 1999 Jul;104(2):173-80. doi: 10.1172/JCI6909.
Results Reference
background
PubMed Identifier
10727452
Citation
Dhodapkar MV, Krasovsky J, Steinman RM, Bhardwaj N. Mature dendritic cells boost functionally superior CD8(+) T-cell in humans without foreign helper epitopes. J Clin Invest. 2000 Mar;105(6):R9-R14. doi: 10.1172/JCI9051.
Results Reference
background
PubMed Identifier
10357375
Citation
Larsson M, Jin X, Ramratnam B, Ogg GS, Engelmayer J, Demoitie MA, McMichael AJ, Cox WI, Steinman RM, Nixon D, Bhardwaj N. A recombinant vaccinia virus based ELISPOT assay detects high frequencies of Pol-specific CD8 T cells in HIV-1-positive individuals. AIDS. 1999 May 7;13(7):767-77. doi: 10.1097/00002030-199905070-00005.
Results Reference
background
PubMed Identifier
11029005
Citation
Rosenberg ES, Altfeld M, Poon SH, Phillips MN, Wilkes BM, Eldridge RL, Robbins GK, D'Aquila RT, Goulder PJ, Walker BD. Immune control of HIV-1 after early treatment of acute infection. Nature. 2000 Sep 28;407(6803):523-6. doi: 10.1038/35035103.
Results Reference
background

Learn more about this trial

Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients

We'll reach out to this number within 24 hrs