Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV (LIFE-HIV) Trial
Goal of Study
The National Institutes of Health (NIH) is conducting a research study of a medication called losartan (or COZAAR). This study may provide information that will improve the health of HIV-positive people who are already on HIV medicines. Losartan is approved by the Food and Drug Administration (FDA) but not for treatment of HIV infection; it is commonly used to treat high blood pressure. Use of losartan in this study is investigational. However, we think this medication may help address some of the damage that HIV causes in the body.
Damage caused by HIV infection results in problems with the immune system. These problems cannot be fully corrected, even with effective treatment using antiretroviral medications. One of these problems is inflammation. ‘Inflammation’ occurs when the body’s immune system responds to injury or infection. Inflammation can be helpful in the short term, but when it is persistent it can also cause more damage to the body over time. HIV also damages the immune system by causing scarring in tissues such as lymph nodes. This scarring limits recovery of the immune system after treatment with antiretroviral therapy is started. Participants with a palpable lymph node in their groin may be eligible for two lymph node biopsies while on study.
A total of 100 individuals are expected to participate in this study. Individuals are being recruited at four different clinical sites in the United States. If you agree to participate in this study, you will be asked to take losartan or a matching placebo medication for 12 months. At the beginning of the study you will be randomly assigned to start either losartan or a placebo (inactive pill). Neither you, nor the study investigators, will know which study medication you will take. You will start out taking 50 mg of losartan or matching placebo. If you are not having any problems after two weeks, the dose will be increased to 100 mg of losartan or matching placebo for the rest of the study. The study will last approximately 12 months. After the screening visit, if you qualify, you will come in for a ‘baseline’ study visit within 90 days. You will then return for a clinic visit after two weeks, and then for follow-up visits at 1, 3, 6, 9, and 12 months. Volunteers will be compensated.
- You are HIV-positive and age 50 or older.
- You have taken HIV medications continuously for at least two years.
- You have a CD4 (t-cell) count of less than 600.
- You have a HIV viral load less than 200.
- If you are on daily aspirin therapy or a statin, you do not plan to stop in the next 12 months; if you are not on either of these, you do not plan to start in the next 12 months
- Your systolic blood pressure (the first number) must be over 120.
- You have not been treated for hepatitis C in the past six months with the drugs interferon and/or ribavirin.
- You are not currently taking rifampin (Rifadin).
- You are not currently taking an ACE Inhibitor or an Angiotensin Receptor Blocker (ARB).
- If female, you are not currently pregnant or breast feeding.
- You live in the DC Metro area and can travel to NIH in Bethesda, Maryland.