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Clinical Trial Information

October 2004


Clinical Trial Information
The SMART Study continues enrollment in Houston and around the world. SMART stands for Strategies for the Management of Anti-Retroviral Therapy. The study will involve 6,000 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 lipodystrophy and anal cancer screening; these may require special tests and scans. In Houston, this study is available at several sites: Thomas Street Clinic, the Veteran's Administration Medical Center, the University Clinical Research Center at UT and Montrose Clinic. For more information, call Hilda Cuervo at 713-500-6731. The study Web site is

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 will 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 or call 713-830-3034.

Baylor College of Medicine

Researchers are looking into ways fat cells and fat metabolism are different in people with HIV. People with lipodystrophy have problems with fat metabolism. Leptin is a substance in the body that helps control fat breakdown. Levels of leptin may be low in some people with HIV. Patients with HIV and low leptin levels are eligible to participate in a study looking at the effects of leptin treatments (given by injection) on fat metabolism. A 2-hour screening is needed to measure leptin levels. If you qualify and decide to participate, 3 clinic visits will be required: before starting leptin, 2 months after starting leptin and 4 months after starting leptin. The study is placebo-controlled (study participants all get injections, but only some people get real leptin) and randomized (patients cannot choose a group, but are assigned randomly, like flipping a coin), but all participants will have the option to use leptin after the 4 months of study. Studies can offer compensation ($) and free parking to eligible participants. All lab work and tests are free. Contact Dr. Khaleel Rehman if you are interested or would like more information: 713-441-1654 (phone) or 281-952-3713 (pager).

Coming soon: The Center for AIDS will introduce a new publication, The Houston-area HIV/AIDS Clinical Trials Directory, in November 2004. This comprehensive publication will be updated at least quarterly and will be available on The CFA Web site at under "Publications."

Back to the HIV Treatment ALERTS! October 2004 contents page.

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