Therapeutic Vaccine for HIV

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV, Therapeutic Vaccine

In brief

Background: \- In most people who have human immunodeficiency virus (HIV), the immune system cannot control or cure the infection. Antiretroviral therapy drugs can keep the amount of HIV virus low for a long time. However, this treatment does not remove the virus from the body. In the vast majority of patients antiretroviral therapy also will not protect the body from the virus once treatment stops. Researchers want to see if therapeutic vaccination can help people with HIV. Therapeutic vaccination means giving vaccines to treat an infection that someone already has (HIV, in this case). It may help the body's immune system attack the infection. This study will look at different measures of HIV infection after receiving either therapeutic vaccination or a placebo. Objectives: \- To see whether therapeutic vaccination is safe and can affect how the body responds to HIV infection. Eligibility: \- Individuals between 18 and 65 years of age who have HIV and are taking antiretroviral therapy drugs. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. * During the screening visit and throughout the study until week 56, participants will continue to take their HIV medications. * Participants will be divided into two groups. One group will have the study vaccines. The other will have a placebo. * The first study vaccine or placebo will be given in weeks 4, 12, and 36. The second study vaccine or the placebo will be given in weeks 24 and 48. Blood samples and other tests will be given at each visit. * After the study visit at week 56, participants will stop their HIV medications until week 72. From weeks 58 through 72, they will come in every 2 weeks for study visits; each visit will take about 1 hour to complete. These visits will look at the body s response to the vaccines and their HIV viral load. After week 72, participants will re-start their HIV medications. * There will be follow-up study visits from weeks 76 to 96, with blood tests and other studies.

Key facts

Study ID: NCT01859325
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 33
Starts: 2013-05-10
Expected to finish: 2017-02-26
Last updated by the study team: 2020-03-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

Allergy to amide-type local anesthetics (bupivacaine (Marcaine), lidocaine (Xylocaine), Mepivacaine (Polocaine/Carbocaine), etidocaine (Duranest), prilocaine (Citanest, EMLA cream).
Chronic hepatitis B, as evidenced by a positive test for hepatitis B surface antigen (HBsAg), or chronic hepatitis C virus (HCV) infection, as evidenced by a positive test for HCV RNA. Subjects with a positive test for HCV antibody and a negative test for HCV RNA are eligible.
Changes in cART regimen due to virologic breakthrough.
HIV immunotherapy or vaccine(s) received within 1 year prior to screening.
Any licensed or experimental non-HIV vaccination (e.g., hepatitis B, influenza, pneumococcal polysaccharide) received within 4 weeks prior to study entry.
Interruption of cART for greater than 3 months since its initiation. 8. Any active malignancy that may require systemic chemotherapy or radiation therapy.
Pregnancy or planned pregnancy during the study period or breastfeeding.
Any active malignancy that may require systemic chemotherapy or radiationtherapy.
Immunosuppressive medications received within 6 months before the first study vaccination (Not excluded: (1) corticosteroid nasal spray for allergic rhinitis; (2) topical corticosteroids for mild, uncomplicated dermatitis; or (3) oral/parenteral corticosteroids administered for non-chronic conditions not expected to recur (length of therapy less than or equal to10 days, with completion in greater than or equal to 30 days prior to enrollment).
Evidence of hepatic decompensation in subjects with cirrhosis: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, or screening laboratory results with any of the following:
International normalized ratio of greater than or equal to1.5 x ULN.
Serum albumin less than 3.2 g/dL.
Serum total bilirubin greater than 1.8 x ULN, unless history of Gilbert's disease or deemed related to treatment with atazanavir.
History or other clinical evidence of:
Significant or unstable cardiac disease (e.g., angina, congestive heart failure, recent myocardial infarction, significant arrhythmia).
Severe illness, malignancy, immunodeficiency other than HIV, or any other conditions that, in the opinion of the investigator, would make the subject unsuitable for the study.
AIDS-defining condition.
Known allergy or sensitivity to the components of the investigational therapy.
History of significant cardiac arrhythmia (e.g., supraventricular tachycardia, ventricular tachycardia, and atrial fibrillation/flutter).
Active drug or alcohol use or any dependence other pattern of behaivor that, in the opinion of the investigator, would interfere with adherence to study requirements.
Any active systemic inflammatory or autoimmune disease or condition.
Presence of implanted electronic medical device (e.g., pacemaker, implantable cardiac defibrillator) or surgical/traumatic metal implant in the upper limb and/or upper torso.
Neurological or neuropsychiatric disorder that may interfere with the assessment of safety (e.g., frequent recurring headaches, for example, a pattern of greater than 1 headache/month affecting activities of daily living/work, frequent or severe/complicated migraines, cluster headaches); or history of encephalitis, narcolepsy, stroke with sequelae, moderate/severe major depressive disorder, moderate/severe bipolar disorder, seizure disorder.
Deltoid skinfold measurements (by caliper) of greater than 40 mm.
Body mass index greater than 40.

Where it is running

National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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