Clinical Trial Information

• Fat Wasting Study Looks at Switching Drugs
• Immune Restoration Study
• Study to Test Safety and Anti-HIV Effectiveness of Potential Drug

Fat Wasting Study Looks at Switching Drugs

Some people with HIV experience what is commonly known as lipodystrophy, which includes such symptoms as fat loss in the face, arms, and legs and/or fat gain in the gut, breasts, or back of the neck. A study called "ACTG A5110" is looking at whether fat loss in the arms and legs is caused by specific types of anti-HIV drugs. The study also wants to see if such fat loss can be reversed if a certain type of anti-HIV drug is stopped and replaced with other types. The answers to such questions are not known. The purpose of the study is to try to answer the questions. The study is available locally through the AIDS Clinical Trials Unit (ACTU) at The University of Texas Medical Branch (UTMB) in Galveston. HIV-positive adults (18 years or older) are eligible to participate. Study drugs and study-related clinic visits will be provided at no cost. Some travel or childcare assistance may be available on a limited basis. People are eligible if they are on HIV meds that include either Retrovir or Zerit, if they have undetectable viral loads and T-cell counts of at least 100, and if they have experienced fat loss or wasting in their arms and legs. For more information, contact the ACTU at 409.772.3991 or toll free at 877.324.2288.

Immune Restoration Study

One of the challenges in HIV medicine is to try to restore the immune system to a healthier state after it has been attacked by HIV. Combination HIV therapy helps, but the restoration is still incomplete. Doctors from the AIDS Clinical Trials Unit (ACTU) at The University of Texas Medical Branch (UTMB) in Galveston are trying to find ways to improve immune restoration. In their study, they will use an experimental AIDS vaccine, interleukin-2 (an immune booster), and HIV treatment interruptions to see if immune restoration can be improved. To be eligible, patients must have been receiving combination anti-HIV therapy (3 or more drugs) for longer than 6 months; Ziagen (which is present in Trizivir) cannot be one of the drugs used. Also required are a T-cell count greater than 350 and viral load less than 50, no previous or current AIDS-defining illness (except Kaposi's Sarcoma if less than 5 skin lesions), and no use of an HIV vaccine within the past year. For more information, contact the ACTU at 409.772.3991 or toll free at 877.324.2288. More information about the ACTU research group can be found on the Web at www.actu.utmb.edu.

Study to Test Safety and Anti-HIV Effectiveness of Potential Drug

An experimental nucleoside reverse transcriptase inhibitor (NRTI) called "ACH-126,443" is being tested for safety and anti-HIV effectiveness. This drug is in the same family as drugs like Epivir, Zerit, Videx, and Retrovir. The study (called "Achillion 006") will look at 3 groups of patients, where one group stays on Epivir, but the other groups switch Epivir for ACH-126,443 at either of 2 doses. The patients will be followed in the study for 4 weeks. Although this study does not have much advantage for treatment-experienced patients who need new treatment options, it is a preliminary and necessary step to move the drug forward into longer, more in-depth study. Entry criteria for this study include being on an Epivir-containing drug regimen, experiencing viral rebound after previous HIV suppression (current viral load between 1,000 and 30,000), having T cells greater than 200, and test results showing viral resistance to Epivir. Also, patients must be older than 18 years, cannot be pregnant or breast-feeding, and cannot have any opportunistic infections or hepatitis B or C infection. The study is enrolling locally at Houston's Montrose Clinic. For more information, contact Rick Witt, PA-C, at 713.830.3013.

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