Important note: Information in this article was accurate in October 2003. The state of the art may have changed since the publication date.
Clinical Trial Information
HIV Treatment Alerts - October 2003
Baylor College of Medicine
Researchers are looking into ways fat cells and fat metabolism are different in people with HIV. 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). The following are 3 studies that are currently enrolling.
If you have been recently diagnosed with HIV and have never before taken HIV medications, you might be eligible for a 2-day study looking at fat breakdown in the body. The study involves 2 one-day admissions to the Clinical Research Center (CRC) at The Methodist Hospital in Houston's Texas Medical Center.
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 visits to the CRC will be required: before starting leptin , 2 months after starting leptin, and 4 months after starting leptin.
If you have been recently diagnosed with HIV and have never before taken HIV medications, you might consider participating in a study that will look at genetic changes in fat cells before and after starting HIV medications. Two visits to the Outpatient Department of Ben Taub Hospital are required to take fat cell samples under local anesthesia—before starting HIV therapy and then 6 months later (whether HIV medications were started or not).
Galveston
The AIDS Clinical Trials Unit (ACTU) at The University of Texas Medical Branch (UTMB) in Galveston is conducting several clinical trials. A few of these are listed below. For more information, contact the ACTU at 409-747-0214 or toll free at 877-324-2288.
ACTG A5163: Bone loss is a problem associated with HIV infection and possibly HIV treatment. This study will look at the effectiveness of alendronate (brand name: Fosamax) plus calcium and vitamin D for treating bone loss in people with HIV. To participate in this study, you must have a viral load less than 1000, a T cell count greater than 100, and be on HIV medications for at least 12 weeks with good virus control. Also, you should not plan on changing your diet or exercise habits for the 48 weeks of the study.
ACTG 5093: Depo-medroxyprogesterone or DMPA (brand name: Depo-Provera) is a hormone treatment for women that helps regulate the menstrual cycle and is sometimes used for birth control, among other purposes. This study will look for possible drug interactions with HIV drugs. To participate in this 12-week study, females with HIV must have a viral load less than 10,000 and T cells greater than 200. Also, you cannot have taken DMPA within 180 days before the study, and you cannot have been through menopause. DMPA, but not HIV medications, will be provided for this study.
ACTG A5127: This study will look at the treatment of hepatitis B in HIV+ patients for whom Epivir will not work because of hepatitis B drug resistance. Participants will be given adefovir (brand name: Hepsera) or Viread to treat the hepatitis B. You must be co-infected with HIV and hepatitis B, with an HIV viral load less than 10,000 and a hepatitis B viral load more than 1 million. You cannot have hepatitis C or hepatitis D. You should be taking HIV therapy with good virus control; you should not be taking Ziagen (which is also in Trizivir).
Montrose Clinic
The following studies are enrolling at the Montrose Clinic in Houston.
GS-01-934: This 48-week study will look at an HIV treatment regimen of Viread, Emtriva, and Sustiva compared to Combivir and Sustiva. To participate, you must have never before taken HIV medications. You must also have a viral load greater than 10,000 and not have any kidney, liver, or bone problems. Also, you cannot have had an AIDS-defining condition within 30 days of starting on the study. For more information, contact Rick Witt at 713-830-3013 (ext. 521).
ZEST-QD: The ZEST study will see if HIV+ patients with undetectable viral loads (less than 50) can be switched from a twice-daily (or more) HIV medication regimen to once-daily treatment using Zerit XR, Epivir, and Sustiva. To participate in this study, you cannot be or plan to be pregnant or breastfeeding. You cannot have hepatitis or an active AIDS-defining condition. Also, you should have never before taken a non-nuke (Sustiva, Viramune, or Rescriptor). Other criteria apply. For more information, contact Mark Mall at 713-830-3018 (ext. 520).
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Important note: Information in this article was accurate in October 2003. The state of the art may have changed since the publication date.
