Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients

August 23, 2007 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

Immune Responses to Antigen-Bearing Dendritic Cells in HIV-Infected Individuals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Principal Investigator: Nina Bhardwaj, MD, PhD, New York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Registration Dates

First Submitted

April 11, 2003

First Submitted That Met QC Criteria

April 11, 2003

First Posted (ESTIMATE)

April 14, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

August 27, 2007

Last Update Submitted That Met QC Criteria

August 23, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01AI044628 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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