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(EMI-0829) Poly-ICLC/Placebo


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Simultaneous Disruption of Latency and Immune Enhancement by Poly-ICLC during HIV-1 Infection

Principal Investigator:
Elizabeth Miller

Investigators:

Contact Information:
Recruitment Specialist
1230 York Avenue
New York, NY 10065
Telephone: 1800RUCARES
Alt. Telephone: 1800RUCARES
Email: rucares@rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
This study involves researching new approaches to treating HIV infection. Currently, HIV infection is treated with combinations of drugs called antiretrovirals. These drugs protect cells from infection by interfering with the viruses’ ability to make copies of itself by infecting new target cells. Though these drugs are very effective, they cannot cure HIV infection and must be taken each and every day at prescribed doses to maintain their beneficial effect. In this research study we are investigating a new approach that involves an addition to existing medications. We are investigating a medication called Poly-ICLC (Hiltonol®, Oncovir), which is an adjuvant. Adjuvants are medications that are designed to boost your body’s immune responses resulting from a vaccine. We want to test whether Poly-ICLC is an adjuvant that is safe and effective in HIV-infected patients. We are not giving a vaccine in this study, but just investigating the adjuvant, Poly-ICLC, to determine whether it is safe and may be useful in future vaccines that could be used to treat HIV, called therapeutic vaccines. One goal of future therapeutic vaccines is to reduce the virus that remains persistently inside of cells in a dormant or resting state despite treatment with HIV medications. This persistent pool is termed the “latent virus pool” or “viral reservoir”. One tactic to reduce this viral reservoir is to first stimulate HIV to start replicating in order to force it out of hiding. Once viral replication occurs, the infected cells may then be recognized and killed by cells of the immune system. Therefore, we also want to see what effect Poly-ICLC has on the virus that lives inside of cells. Specifically, we want to look at whether Poly-ICLC increases the level of virus inside your cells while also improving your immune system’s responses. We are doing this research because we hope to find new ways to treat HIV infection that may reduce exposure to medications that are called antiretrovirals. Antiretrovirals are medications used to treat HIV infection. They are very effective but have side effects and have to be taken each and every day and cannot cure HIV.



Detailed Description of Protocol:




What specifically makes a person eligible for the study?
You may be eligible to enter this study:

1) You are between the ages of 18 and 55 and have been infected with HIV the virus that causes AIDS. 2) You are currently taking medications to treat your HIV infection. 3) Your level of virus in the blood has been below the level of detection (<50 copies/ml) for 48 weeks or longer. 4) You are not pregnant, breast-feeding and do not plan on becoming pregnant for the duration of this study. 5) You have never had a history of vascular disease including a heart attack, stroke, mini-stroke, poorly controlled high blood pressure or symptoms that could indicate you have these conditions. 6) You do not have diabetes. 7) You do not have elevated cholesterol that requires medication. 8) You do not have a strong family history of heart disease. 9) You have never taken immune based therapy for HIV and you are not currently taking medications that affect the immune system. 10) You do not have drug-resistant HIV. 11) You are not taking cancer chemotherapy. 12) You do not have autoimmune disease such as lupus or rheumatoid arthritis. 13) You do not have active co-infection with Hepatitis B or Hepatitis C. 14) You have not participated in any other clinical trial within 30 days. 15) You do not use drugs or drink alcohol excessively such that you would not be a reliable participant in the study.

Gender:
Both

Age(s):
15-55

Children permitted to participate:
No

Potential Benefits.....
If you take part in this study, we do not expect there to be a benefit to you, but it is possible there will be a benefit to you. What we learn from this study may help others who have HIV in the future.



Compensation:
compensation and lunches are provided