ACRIA Trials in Progress

Ampligen and HAART With Treatment Interruptions

This trial will study the effects of the addition of Ampligen to HAART in people with HIV. People who have been on a stable HAART regimen for at least 4 months will add Ampligen either immediately or after 24 weeks. Ampligen is given as an hour-long infusion twice a week.

Ampligen is an immunomodulator with a low incidence of side effects. It can stimulate interferon and other cytokines, as well as other intracellular antiviral defense mechanisms. This trial will study whether Ampligen can assist the immune system's response to carefully monitored Strategic Therapeutic Interruptions (STIs) of HAART. The theory is that Ampligen will lengthen the HAART-free time interval with a resultant decrease in HAART-induced toxicities. The hope is that Ampligen will maximize STIs to the point that the cell-mediated immune system response might be sufficient to eliminate the need for HAART.

Adults with a CD4 count of 300 or more and a viral load over 500 but less than 30,000 within 40 days, can join this 48 week study. Participants make 44 visits to ACRIA. All blood tests, study visits and study drugs will be provided at no charge. Once you have been enrolled you will be reimbursed for each visit.

For more information, call Dr. Douglas Mendez at (212) 924-3934 ext. 126.

Resurgex Pilot Study

This study will evaluate the safety and effects of Resurgex on metabolic, virological, and immunological parameters in people with HIV.

Resurgex is a nutritional supplement developed by Millennium Biotechnology, Inc. Its components have been designed to nutritionally address problems encountered in HIV disease and in antiretroviral drug treatment. Most of the ingredients contained in Resurgex are available individually at health food stores. What makes Resurgex unique is its combination of superoxide dismutase (SOD, a potent antioxidant enzyme) with gliadin (a wheat-based natural polymer), to make SOD absorbable in the digestive tract.

People with HIV who have been on HAART therapy for at least 16 weeks or have never been on antiretroviral therapy (or have not taken it for at least 24 weeks), and who do not currently take any additional fortified nutritional supplementation, may be eligible for this study.

This study will last approximately 6 months, with at least 10 visits to the Harlem United Community AIDS Center on 124th St. in Manhattan. All blood and investigational tests, study visits, and study investigational products will be provided at no charge. Participants are reimbursed $25 when they enroll, with an additional $25 when they complete the study.

For more information, call Dr. Eugen Vartolomei at 212-924-3934 ext. 125.