NCT00058734

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2003

Completed
Last Updated

August 27, 2007

Status Verified

August 1, 2007

First QC Date

April 11, 2003

Last Update Submit

August 23, 2007

Conditions

HIV Infections

Keywords

Dendritic CellImmunotherapyAcute HIVHuman Immunodeficiency VirusAIDSHIV Therapeutic VaccineTreatment ExperiencedTreatment Interruption

Interventions

Dendritic Cells Pulsed with HIV antigensBIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (4)

  • 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.

    PMID: 10411546BACKGROUND

  • 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.

    PMID: 10727452BACKGROUND

  • 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.

    PMID: 10357375BACKGROUND

  • 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.

    PMID: 11029005BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

HIV Antigens

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

Antigens, ViralViral ProteinsProteinsAmino Acids, Peptides, and ProteinsAntigensBiological Factors

Study Officials

  • Nina Bhardwaj, MD, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

April 11, 2003

First Posted

April 14, 2003

Study Start

November 1, 2000

Last Updated

August 27, 2007

Record last verified: 2007-08

Locations

US(1)