(RITA!) HIV Treatment Alerts - May 2003

• ACTG A5157: This study will look at the effectiveness of acetyl-L-carnitine for the treatment of peripheral neuropathy associated with certain anti-HIV drugs like Videx, Zerit, and Hivid. To participate in this study, you must be experiencing symptoms such as pain in the feet or legs, with the pain starting or worsening within 12 months of taking of any of those drugs. Also, you must currently be taking any of those drugs with stable HIV control for at least 8 weeks. Your viral load must be less than 10,000. You must not have diabetes, nor have taken any new pain medication or treatment for peripheral neuropathy within the last 60 days. The study takes 24 weeks with a total of 6 visits. Two skin biopsies are needed by researchers to test for any improvements in nerve damage. Acetyl-L-carnitine will be provided (but not after study).
  
• ACTG A5110: This study will look at whether fat wasting in the arms and legs can be stopped or possibly reversed by substituting or changing anti-HIV drugs. To participate in this study, you must be currently receiving Retrovir or Zerit. Your viral load must be less than 500, and your T cells must be greater than or equal to 100. You must also have experienced weight loss (wasting) in your arms and legs. The anti-HIV drugs Kaletra, Ziagen, and Viramune will be provided during the study.
  
• ACTG A5132: Using interleukin-2 (an immune booster) with up to 3 interruptions of anti-HIV treatment, researchers in this study will look at whether immune reactions specifically against HIV can be enhanced. They will also see if interleukin-2 influences the amount of time to viral rebound after stopping anti-HIV therapy. To enroll in this study, your viral load must be less than 50, and your T cell count must be at least 300. Also, you must have been on combination anti-HIV therapy (3 drugs) for at least 6 months. Use of other immune boosters or hydroxyurea may keep you from participating in the study. Interleukin-2 will be provided.

SMART study
The SMART Study continues enrollment in Houston and around the country. SMART stands for Strategies for the Management of Anti-Retroviral Therapy. The study will involve 6000 patients and last for at least 8 years. The study's planners hope to learn whether delayed, broken-up treatment for HIV is just as effective as immediate, uninterrupted treatment. They will also gather information on the long-term side effects of HIV treatment and effects 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. For more information, call Hilda Cuervo at 713.500.6731. The study website is www.smart-trial.org.

Studies enrolling at Montrose Clinic
The following studies are enrolling at the Montrose Clinic in Houston. To find out more information, contact Rick Witt at 713.830.3013, extension 521.

• A4311006: Capravirine is an experimental non-nucleoside reverse transcriptase inhibitor ("non-nuke"). This drug may be active against HIV that is resistant to other non-nukes like Sustiva and Viramune. This study will look at the combination of capravirine and Kaletra in patients who have failed other anti-HIV drugs. To be eligible for the study, you must have HIV that became resistant to at least 1 (but no more than 3) protease inhibitors, 1 non-nuke, and at least 2 nukes (such as Epivir, Ziagen, Zerit, Videx, or Retrovir). Your viral load must be greater than 1000.
  
• MDX010-10: The antibody MDX010-10 works by binding to the CD4 receptor on T cells and affecting the body's immune response to HIV. Such antibodies may be a new type of anti-HIV therapy for people with HIV, but more research is needed. Patients with drug-resistant HIV (verified by resistance testing) who have gone through 2 prior drug regimens are eligible for this study. T cell count must be greater than or equal to 100, and viral load must be between 1000 and 100,000.

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Copyright © 2003 - 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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