Safety, Tolerability and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving HAART

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV Infections

In brief

LC002 is an experimental therapeutic vaccine designed to boost the immune response of people infected with HIV. The purpose of this study was to determine the safety and tolerability of and immune response to LC002 in HIV-1-infected adults who are currently receiving anti-HIV treatment.

Key facts

Study ID

NCT00270205

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

28

Starts

2006-01-01

Expected to finish

2010-09-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV-1-infected
• On a stable HAART regimen without changes or interruptions for more than 4 consecutive days for at least 12 weeks prior to study entry. Patients must be currently taking regimens containing drugs of at least two different classes.
• Two readings of plasma HIV-1 viral load of less than 50 copies/ml within 30 days prior to study entry. More information on this criterion can be found in the protocol.
• CD4 count greater than 350 cells/mm\^3 within 12 weeks prior to study entry
• Lowest CD4 count greater than 250 cells/mm\^3 at any time prior to study entry
• Willing to use acceptable forms of contraception
• Karnofsky performance score 90 or higher obtained within 30 days prior to study entry

You may not qualify if…

• HIV-1 viral load greater than 500 copies/ml within the 24 weeks prior to study entry
• History of or current active skin disease (e.g., atopic dermatitis, psoriasis) or any chronic autoimmune disease (e.g., Graves' disease). Participants with minor, localized skin conditions that, in the opinion of the investigator, do not represent a safety concern, are not excluded.
• Treatment with topical corticosteroids at the proposed vaccination sites (Cohort 1: left and right upper back; Cohorts 2 and 3: left and right upper back and left and right upper ventral thigh) within 2 weeks of study entry
• Excessive exposure to the sun (e.g., sunbathing, tanning bed) within 2 weeks prior to study entry
• Laser hair removal within 2 weeks prior to study entry
• Use of any local skin treatments (e.g., topical/chemical hair removal, ointments, possible irritants) to the targeted vaccination sites within 7 days prior to study entry
• History of diabetes or bleeding disorders
• Previous CDC Category C event. More information on this criterion can be found in the protocol.
• Use of immunomodulating therapy, including cyclosporine, IgG-containing products, interleukins, interferons, or systemic glucocorticosteroids (including those inhaled) within 6 months prior to study entry
• Exposure to an experimental HIV vaccine within 6 months prior to study entry
• Any vaccine within 30 days prior to study entry
• Investigational products within 12 weeks prior to study entry
• Allergy or sensitivity to study vaccine products, adhesives, or polyester
• Current drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study
• Serious illness requiring systemic treatment and/or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
• Positive hepatitis B surface antigen or positive anti-hepatitis C antibody at screening
• History of treatment with HAART during primary infection
• History of lymph node irradiation
• Pregnant or breastfeeding
• Certain abnormal laboratory results. More information on this criterion can be found in the protocol

Where it is running

• Univ. of California Davis Med. Ctr., ACTU — Sacramento, California, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Case CRS — Cleveland, Ohio, United States
• MetroHealth CRS — Cleveland, Ohio, United States
• University of Pittsburgh CRS — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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