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Open Clinical Trials

Summer/Fall 2010

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EraMune: HIV Eradication

A cure for HIV -- either total viral eradication or a "functional cure" that allows people to stop taking ART -- has been a topic of increased attention this year. The EraMune02 trial (a collaboration between the U.S. National Institute of Allergy and Infectious Diseases, the French vaccine research group ORVACS and others) will evaluate whether an intensified combination ART regimen along with an immune-modulating vaccine can eliminate HIV from the body, including hidden reservoirs.

In this Phase II trial, participants on standard ART with stable undetectable viral load will intensify therapy by adding the integrase inhibitor raltegravir (Isentress) and the CCR5 blocker maraviroc (Selzentry) for 56 weeks. Some will be randomly assigned to do this alone, while others will also receive an adenovirus-based therapeutic HIV vaccine. Investigators will measure plasma viral load, proviral HIV (latent HIV genetic material in resting cells) and HIV in gut lymphoid tissue; they will also look at HIV-specific immunity and T-cell activation.

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Participants must be 18 to 60 years of age and on uninterrupted ART for at least three years. They must have had plasma viral load below 500 copies/mL for three years and below the limit of detection during the past year, as well as proviral DNA between 10 and 500 copies. CD4 count must be at least 350 cells/mm3. There are additional criteria for adenovirus titers and blood cell counts. Exclusion criteria include hepatitis B or C coinfection, recent cancer, history of autoimmune disease, certain laboratory abnormalities, previous use of integrase inhibitors or CCR5 antagonists and recent use of immune-based therapies. Women may not be pregnant or breastfeeding and all participants must agree to use barrier contraception.

EraMune02 will enroll 28 participants in the U.S. at the University of California at San Francisco (415-476-4082), Northwestern University in Chicago (312-695-5012) and Cornell University in New York City (212-746-7262). A similar study in Europe is evaluating ART intensification plus interleukin 7 (IL-7). www.clinicaltrials.gov/ct2/show/NCT00976404.


CD4 Cell Gene Therapy

Another investigational approach to curing HIV is modifying CD4 T-cells to make them resistant to HIV entry. Sangamo Biosciences is conducting trials to test whether a zinc finger nuclease can be used to remove the gene for CCR5, one of the coreceptors HIV uses to enter host cells. People who naturally lack the CCR5 coreceptor are protected from HIV infection and disease progression, and studies have shown that humanized mice with CD4 cells altered in this way experience less HIV disease progression and CD4 cell loss.

Two related non-randomized Phase I trials are testing this approach in humans. Participants' CD4 cells will be obtained using a process called apheresis, in which blood is withdrawn, desired cells are removed and the rest of the blood is returned to the body. Collected CD4 cells will be altered in the laboratory using the zinc finger (SB-728-T) technique, allowed to reproduce and then returned to the patient. Participants will receive a single infusion containing one to three batches of 5-10 billion modified cells.

Investigators will evaluate the safety of the procedure, and measure the activity and persistence of the altered CD4 cells; some participants will be followed for as long as 10 years. A small number of participants in one trial will undergo ART interruption to see if the modified cells are protected from HIV infection.

The studies will enroll different types of patients. Some will have been on antiretroviral treatment for at least two years with continuous undetectable viral load starting six months after ART initiation, but with suboptimal CD4 cell recovery (below 500 cells/mm3). Other participants will be on ART but still have viral load of 1,000 copies/mL or higher; some will have experienced treatment failure on two or more ART regimens.

Participants must be at least 18 years of age. Exclusion criteria include recent AIDS-defining illness, chronic hepatitis B or C coinfection, most cancers, certain laboratory abnormalities, recent use of certain drugs (including maraviroc, enfuvirtide [Fuzeon], and immune-modulating agents) or vaccines. Women may not be pregnant or breastfeeding and participants must agree to use effective contraception.

One trial aims to enroll 13 participants at the UCLA Center for AIDS Research and Education in Los Angeles (310-557-3729) and Quest Clinical Research in San Francisco (415-353-0212); www.clinicaltrials.gov/ct2/show/NCT01044654 (SB-728-0902). The other will enroll 18 people at the University of Pennsylvania in Philadelphia (215-349-8091) and Jacobi Medical Center in the Bronx (718-918-3662); www.clinicaltrials.gov/ct2/show/NCT00842634 (806383).

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This article was provided by San Francisco AIDS Foundation. It is a part of the publication Bulletin of Experimental Treatments for AIDS. Visit San Francisco AIDS Foundation's Web site to find out more about their activities, publications and services.
 
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Specific U.S. Nationwide Studies
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