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CompletedNCT00058734Updated Aug 27, 2007

Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients

A Phase 1 interventional study of Dendritic Cells Pulsed with HIV antigens in HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-08-27.

Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • HIV Infections

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Keywords

  • Dendritic Cell
  • Immunotherapy
  • Acute HIV
  • Human Immunodeficiency Virus
  • AIDS
  • HIV Therapeutic Vaccine
  • Treatment Experienced
  • Treatment Interruption
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In context

HIV Infections

4,257 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 5 is below the median of 83 across 3,250 interventional studies indexed under HIV Infections.

Browse HIV Infections studies →

Lead sponsor

National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.

Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Interventions

  • BiologicalDendritic Cells Pulsed with HIV antigens
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Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
07

References and documents

Publications

  • 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. PubMed 10411546 ↗
  • 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. PubMed 10727452 ↗
  • 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. PubMed 10357375 ↗
  • 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. PubMed 11029005 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00058734
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
First posted
Apr 14, 2003
Start date
Nov 2000
Last update
Aug 27, 2007

Study contacts

Nina Bhardwaj, MD, PhD
principal investigator · New York University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2007. You cannot join it, but the record below documents what was studied.

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