BEAT-HIV Study - Beyond Antiretroviral Treatment: Reducing Proviral HIV DNA with Interferon Immunotherapy
Brief Description Of Study
The NIH is paying for this study. When a person has HIV, some of the virus hides in blood and tissues. HIV drugs cannot completely remove HIV from the body. This “hidden virus” is known as the viral reservoir. Scientists think that the reservoir may be why HIV cannot be cured. This study has three main goals: (1) to test if the drug Pegintron® is safe and can lower how much hidden HIV is in your blood and tissues, (2) to find out if a short-term break from your current HIV drugs (12 weeks maximum) is needed for Pegintron® to reduce the amount of hidden HIV in your blood and/or tissues, and (3) to verify the safety of these methods.
Detailed Study Description
This is a clinical trial to test if a needle form of Interferon-alpha-2b called Pegintron® can reduce the amount of hidden HIV in blood and tissues. A similar study took place in the last three years. Some patients had lower HIV levels in the blood after stopping their HIV medications. If you agree to enroll, you will be randomly assigned to one of three groups. Group 1 receives 20 weeks of Pegintron® with a 12-week interruption of HIV medications. This tests if an interruption from medications is required for the Pegintron® to reduce HIV in blood and tissues. Group 2 receives 20 weeks of Pegintron® with no interruption of HIV medications. This tests if Pegintron® will work without interrupting HIV treatment. The third group, called a control group, does not receive Pegintron® and does not interrupt their HIV medications. The “control” allows the study team to compare blood and tissues from each group. To measure the effects of Pegintron®, we will compare the levels of HIV (viral load) in blood and tissues between these three groups.
Additional Information About The Study
A detailed description of this clinical trial is available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, when the study is finished the Web site will include a summary of the results of our study. You can search this Web site at any time.