Therapeutic Vaccination Followed by Treatment Interruption in HIV Infected Patients

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00058734

Collaborator

(none)

Enrollment

Location

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: Dendritic Cells Pulsed with HIV antigens	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

5 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

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:

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