AEGiS-RITA! HIV Treatment Alerts: Clinical Trial Information

Important note: Information in this article was accurate in April 2002. The state of the art may have changed since the publication date.

Clinical Trial Information

(RITA!) HIV Treatment Alerts - April 2002

Study to focus on patients with drug-resistant HIV
The Montrose Clinic is now enrolling patient volunteers for a study of multi-drug resistance. The study (called CPCRA 064) will use viral resistance testing to see what drugs might still work against a patient's HIV. From the resistance tests, new drug combinations will be figured out that hopefully should work against the virus. Two groups of patients will be studied: one that starts the new drug regimens right away, and one that starts the new drug regimens after a 4-month treatment interruption. Patients will participate in this study for at least 2 years. To be eligible, patients must be on anti-HIV therapy and have viral loads above 5000. Resistance testing should show virus resistant to multiple drugs. Patients are not eligible if they have been recently vaccinated, are ill (especially with an opportunistic infection), have recently used interleukin-2 (IL-2), or are pregnant. For more information, contact Jesse Rios, RN, at 713.830.3050.

Atazanavir: an experimental protease inhibitor
A study sponsored by drug maker Bristol-Myers Squibb is looking at atazanavir in combination with other anti-HIV drugs. This study (called BMS 045) is being done to help determine the safety and effectiveness of atazanavir. This drug has not been approved yet by the Food and Drug Administration (FDA). The results from studies like this one usually help the FDA to decide whether or not to approve a drug. Patients with viral loads of 1000 or more and T cells greater than 50 are eligible. Patients are not eligible if they have a history of pancreatitis, heart disease, hemophilia, or recent hepatitis or opportunistic infection. Patients are also not eligible if they are pregnant or have received atazanavir or the other study drugs in the past. For complete details and more information, contact Mark Mall, RN, at the Montrose Clinic (713.830.3018).

Mycophenolic acid study
A study being done locally by Dr. Joseph Gathe will look at the effects of mycophenolic acid in combination with anti-HIV drugs as part of "salvage" therapy for highly drug-experienced patients. No specific T cell or viral load levels are required. For more information, contact Marketer Washington or Delishia Sapp at 713.526.9821.

SMART now enrolling
SMART stands for Strategies for the Management of Anti-Retroviral Therapy, and it will be the largest, most ambitious clinical trial in the history of the HIV/AIDS epidemic. The study will involve 6000 patients and last for as long as 8 years.

Driven by common knowledge that anti-HIV drugs are toxic, the study's planners are hoping to learn whether delayed, broken-up treatment for HIV is just as effective as immediate, uninterrupted treatment. The study will also gather information on the long-term side effects of HIV treatment and its effect on quality of life.

The study is open to anyone with HIV, male or female, who is at least 13 years old. To volunteer, you must have a T cell count of at least 350 and you must be willing to start, stop, or change anti-HIV drug therapy, depending on the study group to which you are assigned. For the first year of the study, you will have to see the doctor once every 2 months. After that, you will see the doctor 3 times a year. For safety, you cannot volunteer for the study while you are pregnant, but you can volunteer after you have had your baby.

In Houston, this study is available at 3 sites: Thomas Street Clinic, the Veteran's Administration Medical Center, and Montrose Clinic. The head doctor for the study is Roberto Arduino, MD, an associate professor of medicine at the University of Texas–Houston Medical School.

For more information, call Hilda Cuervo at 713.500.6731.

Hemophilia: a disease that interferes with blood clotting and can result in uncontrolled bleeding.

Hepatitis: inflammation of the liver that can have a variety of causes including viruses, medications, etc.

Opportunistic infection: a disease caused by an organism that is usually harmless, but becomes activated when a person's immune system is impaired or damaged.

Pancreatitis: inflammation of the pancreas, an internal organ, usually involving pain in the upper abdomen (just under the ribs) and possible nausea and vomiting.

Toxic: being poisonous or damaging to the body.

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Copyright © 2002 - Research Initiative Treatment Action (RITA!). Reproduced with permission. RITA! is published by The Center for AIDS. Contact Thomas Gegeny, MS, ELS, Editor, RITA! for permission to reproduce RITA!. tom@centerforaids.org. http://www.centerforaids.org

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