Gay Atlanta men who PrEP and sex can help a study that's investigating a promising new HIV drug that could eventually be PrEP 2.0 – a daily HIV prevention regimen with fewer side effects.

The AIDS Research Consortium of Atlanta hopes to recruit up to 150 HIV-negative gay men and transgender women as part of a nationwide study of about 5,000 people. Researchers want to compare the effectiveness of Truvada, a once-a-day pill of Tenofovir and Emtricitabine that's highly effective at preventing HIV, with a new drug from Truvada maker Gilead Sciences.

The new drug, a type of Tenofovir called F/TAF, is effective in treating HIV but with less toxicity and impact on the kidneys and bones, according to Melanie Thompson, ARCA's principal investigator. 

Researchers hope the combination can become a new HIV prevention agent – call it PrEP 2.0.

"PrEP is going to evolve over time. We started with one drug," Thompson (second photo) said.  

"This drug, if it works for prevention, may offer some improvement over the current drug and give people more options. I think we're going to see much more of this as years come. Truvada is the first PrEP but it certainly won't be the only PrEP. The more options people have the better," she added.

The study will unfold over three years and provides participants with condoms, lube and testing for sexually transmitted infections during every study visit. After a handful of visits in the first month, participants will then settle into a schedule similar to what people taking PrEP undergo – a visit about every three months, Thompson said.

During the course of the study, researchers will also monitor the effect of the trial drug on bone density. Initial results show that F/TAF has less impact than Truvada, she said.

"Truvada does cause a little bit of loss of bone density. Usually it's not clinically significant. In the treatment studies, the bone density of F/TAF have been less than with Truvada. We want to find out if that is also true with people that don't have HIV," Thompson said.

During the first two years of the trial, participants receive either the current PrEP prevention or the new F/TAF regimen. In the third year, everyone in the study shifts to F/TAF.

"Everyone will take two pills once per day, but everyone will definitely be getting real drugs. Nobody gets nothing," Thompson said.

Study participants receive $50 per visit for their travel and time, with additional stipends if they undergo bone scans. Additionally, Thompson said, the study provides the drugs, labs, physical exams, and HIV and STI testing.

"We want to be sure that if anyone has a sexually transmitted infection that we can identify it and help them get treated," Thompson said.

The study is enrolling gay and bisexual men, and transgender women who are HIV-negative and at least 18 years old.

 

Two studies for people with HIV

 

ARCA is also recruiting volunteers for two other HIV-related studies. 

The FLAIR study is exploring a once-per-month injection of drugs to suppress HIV in an effort to replace current treatments that are often taken daily. The study will include 620 people across the country, including Atlanta. 

But the promising treatment – and study – is limited to people recently diagnosed with HIV who have not yet started treatment for it. Study participants will begin treatment with Triumeq, a new all-in-one HIV treatment, and randomly be selected to continue with that or shift to the injectable regiment of Cabotegravir and Rilpivirine.  

"There is obviously something attractive about taking medicines once a month," Thompson said. 

The injectable HIV treatment is investigational, Thompson noted, but so far has shown to be safe and well-tolerated by people taking it.

"This will be a study that really gives us more information about whether these will be viable options," Thompson added.

Participants will take part in the study in ARCA's offices on Ralph McGill Boulevard, which offers a quieter environment than a typical medical clinic, Thompson said. They will also undergo education about HIV and support to help with their new diagnosis, she said.

"It's important that people understand not only the study but what the disease is about. We do provide a lot of support for people and a lot of education. We can help people who are trying to struggle through what it means to have HIV," Thompson said. 

Participants receive $50 per visit to help compensate them for travel and their time.

ARCA is also recruiting at least 10 people for a nationwide study of 240 participants to investigate new medications to treat people with both HIV and hepatitis C. Participants will change their current HIV medications to either Genvoya or Odefsey for eight weeks. If that change goes well and their HIV remains undetectable, participants then receive Harvoni for 12 weeks and then be observed for 12 more weeks, Thompson said. 

"Hopefully, they will be cured of their hepatitis C. It's a pretty straight-forward study but it does provide access for hepatitis C treatment for people who qualify for the study," Thompson said.

Participants in the study must be eligible to change their existing HIV treatment. They will be paid $50 per visit.

For more information about the studies, visit ARCA's website.