AEGiS-RITA! HIV Treatment Alerts: Clinical Trial Information

Important note: Information in this article was accurate in June 2004. The state of the art may have changed since the publication date.

Clinical Trial Information

HIV Treatment Alerts - June 2004

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 goal of the study is to learn whether delayed, broken-up treatment for HIV is just as effective as immediate, uninterrupted treatment. Information will also be gathered on the long-term side effects of HIV treatment and effects on quality of life. The study is open to men and women with HIV, age 13 or older. To volunteer, you must have a T cell count of at least 350 and you must be willing to start, stop, or change HIV medications, 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 the baby is born. Some patients who enroll in the study will be able to participate in smaller substudies focusing on topics like lipodystrophyand anal cancer screening; these may require special tests and scans. 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.

Heart Positive study

The Montrose Clinic and Baylor College of Medicine in Houston are participating in a study called "Heart Positive." The study aims to answer important questions about how to reduce heart disease and diabetes risk in people with HIV, especially those who show signs of lipodystrophy. The study is open to men and women with HIV, age 18 to 65, who have been taking combination HIV medications for at least 6 months. The study will look at lifestyle changes (diet and exercise) and the use of medications to control levels of fats in the blood. The study is placebo-controlled (study participants may take pills, but only some people get real medicines) and randomized (patients cannot choose a group, but are assigned randomly, like flipping a coin). These study rules help the doctors find out what will work or not work in reducing the risk of heart disease and diabetes in people with HIV. To find out more information or to discuss enrolling in the study, visit www.heartpositive.org or call 713-830-3034.

Study for HIV-related neuropathy

People with HIV can experience pain called neuropathy in their feet and sometimes their hands. This pain can be caused by HIV itself, the medications for treating HIV, or both. A research study is now enrolling to study the effectiveness of an injectable medication called Prosaptide in treating neuropathy. The 13-week trial is placebo-controlled (some people will not be injecting actual medicine). The self-injections must be given once a day. The study requires 2 visits for screening/interviews and 6 study visits for 2 to 3 hours each. Money is given to participants who finish the study. To be eligible, participants must be diagnosed with neuropathy by a study doctor. For more information, call Ghous Khan at 713-773-1331.

New protease inhibitor being studied

For patients with drug-resistant HIV, a new protease inhibitor "TMC 114" may offer some hope. The drug has not been approved yet, but is being studied in people with HIV to determine its effectiveness. The study is open to men and women with HIV, age 18 or older. To be eligible, participants must have experience with the 3 main classes of HIV medications, be currently taking HIV medications that include a protease inhibitor, and have virus with up to 2 major protease inhibitor mutations. Certain issues may prevent participation in the study including current AIDS-defining conditions (opportunistic infections), current treatment interruption, and pregnancy. People who enroll in this study may not be able to take certain other medications. For more information, contact study coordinator Raúl Nuñez at 713-500-5483 (phone) or 713-608-0689 (pager).

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Copyright © 2004 - 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

AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, Bridgestone/Firestone Charitable Trust, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2005. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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