A clinical trial of low-dose methotrexate on inflammation in HIV-infected people who are at risk for cardiovascular disease (CVD): A5314.
Brief Summary and Purpose of this study:
Anti-HIV medicines have been very successful in allowing people with HIV to control the virus. However, researchers have noticed that many patients have high levels of inflammation even when their medicine is controlling their HIV viral load.
Inflammation is the body’s response to infection or irritation that can be helpful sometimes but can cause long-term problems when it lasts too long. Researchers believe that people with high levels of inflammation could, over time, have an increased risk to develop certain health problems such as heart disease, kidney disease, and some forms of cancer.
Anti-HIV medicines can lower levels of inflammation in people living with HIV. Yet levels of inflammation still remain higher in some people with HIV compared with people who do not have HIV.
The main purpose of this study is to look at the safety of low-dose methotrexate for use for the first time in HIV-infected people. We want to learn if treatment with low-dose methotrexate can safely lower the risk of heart disease by lowering HIV-related inflammation.
Half of the people in this trial will get one pill of low-dose methotrexate to take each week. The other half of the people will get a placebo, a pill that does not have medicine in it. Neither the people in the study nor the local research staff will know who gets the real medicine and who gets the placebo.
The dose of the real medicine will be very low at first; then it will be increased after the 1st week and again after the 12th week, if the participants are doing well. People will get the drug or placebo for 6 months, and then be followed for another 3 months without taking the drug. Everyone on the study will take a dietary supplement of folic acid each day.
Key Requirements to enter the study:
- HIV-positive men and women 40 years old and older.
- CD4+ T cells 400 or more.
- Undetectable viral load for at least 6 months.
- Currently on anti-HIV medicines (HAART) for at least 6 months and no plans to change anti-HIV medicines for the next 9 months.
- Must have moderate or high risk of cardiovascular disease; a study nurse can discuss this with you to see if you qualify for the trial.
- No chronic hepatitis B or C infections.
- Other requirements that a study nurse can discuss with you.
The trial lasts for 36 weeks.