REPRIEVE Launches Sub-Study on HIV Heart Health

Back in 2015, EDGE reported on a National Institutes of Health study prompted by research revealing that people with HIV were 50 to 100 percent more likely to develop cardiovascular disease, including myocardial infarctions and strokes.

Over the past two years, REPRIEVE, a Randomized Trial to Prevent Vascular Events in HIV, has grown tremendously. They now have about 2,800 participants and have launched sites throughout the U.S., Canada, South Africa, and Brazil to study the connection between HIV and cardiovascular disease, and to test whether the drug pitavastatin will help reduce heart-related disease in people with HIV.

"It's going really well," said Katie Fitch, MSN, FNP, Project Manager of REPRIEVE. "We have 107 clinical sites and our demographics are about 31 percent female. We are really pleased with that."

Fitch said that a number of factors combine to put people living with HIV at risk for cardiovascular disease. Among them is the inflammation that HIV causes in activated immune cells, which leads to plaque buildup (atherosclerosis) in the arteries, and cardiovascular disease.

In addition, antiretroviral therapy also leads to higher cholesterol levels, which can contribute to cardiovascular disease. And lastly, the HIV-positive population has higher conventional risk factors, such as smoking and obesity.

"Some of the older meds, like protease inhibitors, were also associated with high cholesterol risks factors for cardiovascular health," added Fitch. "People who had lipodystrophy also have higher triglycerides, and trouble with their blood sugar. With new meds, you don't see that as often. Cholesterol abnormalities exist, but not to the same level as lipodystrophy."

To see if you qualify for this study, click here.

Sub-Study Follows Women with HIV

Now, just in time for February's Heart Health Month and March's Women's History Month, comes the REPRIEVE Follow Your Heart study. This is a separately funded NIH study integrated into study to evaluate sex-specific results, and it will be limited to U.S. sites, although the outreach campaign will be global.

"It is well-known -- even in women without HIV -- that there are sex-specific differences in regard to heart disease," said Sara Looby, PhD, ANP-BC, FAAN, co-principal investigator of the Follow Your Heart study. "For example, in menopause you lose the protective effect of estrogen, which can put you at risk. However, no one has carefully looked at whether women with HIV as they enter menopause will be at risk, as well as some of the nontraditional risks of heart disease. When REPRIEVE was funded, there was an interest in looking at cardiovascular disease and inflammation among women, so we applied for funding to answer some of these important questions."

The Follow Your Heart study will be held during the same time as the regular REPRIEVE study. In addition to looking at the sex-specific risk factors among women with HIV, they will also develop an educational campaign for women with HIV about associated heart disease, and the importance of their clinical research participation.

"Women with HIV might not be strongly represented in these trials, and it might be harder to extrapolate sex-specific differences," said Looby. "The Follow Your Heart campaign collects feedback from women with or at risk for HIV heart disease, asks them about how they learn about these trials, and teaches them how to participate in other clinical trials."

Looby said that the enrollment specifications for Follow Your Heart are the same as for the larger REPRIEVE study, with no capped enrollment. As she noted, "the more the merrier; that's the beauty of REPRIEVE. It can have 6,000 participants, and the result will be better statistics."

There are four more years left before the REPRIEVE study wraps up. Right now, the major benchmark is enrollment, which Fitch said they hope to finish by the end of 2018.

"We are leaving plenty of time for people to enroll, but we want them sooner rather than later, so we can follow them longer," said Fitch. "If someone is interested in participating, we are looking for people with a CD4 count about 100, who are on ART and relatively healthy. They can go to the website to see more."

The HIV-positive community came together to help develop effective ARTs that work with as little as one pill a day. Now, as people with HIV are aging and we seek a primary prevention tool for heart disease, the HIV-positive community must again come out in force to support this trial, said Fitch.

Besides the benefit of helping people live longer, healthier lives, participants in the clinical research study will become educated on healthy lifestyles, have time to talk to doctors about HIV and heart disease, and may receive other compensation. Fitch said that most participants have said taking one additional pill was not a burden.

REPRIEVE, which plans to enroll 6,500 participants, will be the largest study to date to test a cardiovascular disease prevention strategy in HIV. And now, they have the unique objective to study sex differences in cardiovascular disease and response to statin therapy.�This is extremely important as researchers have found that women living with HIV are three times more likely than those without HIV to experience heart disease. Ultimately, the REPRIEVE study will teach us whether pitavastatin lowers heart disease risk in women as well as it lowers risk in men.�