Family Health International (FHI), a nonprofit global health and development organization working to improve the lives of the world's most vulnerable people, recently joined the Tuberculosis Trials Consortium (TBTC), an international body that researches new TB drugs and treatment strategies. The consortium is funded by the US Centers for Disease Control and Prevention (CDC). As part of the consortium, FHI is partnering with Duke University Medical Center to conduct clinical trials that aim to reduce the duration of TB treatment and lessen the side effects of TB drugs.
The work of the TBTC is advancing the development of improved TB treatment, which has remained largely unchanged for 50 years. First-line TB treatment involves taking four pills once a day for six to nine months. Strict adherence is critical: patients who miss doses may relapse or acquire resistance to TB medicines. By establishing shorter, less toxic treatment regimens, scientists hope to facilitate adherence to TB treatment, increasing the likelihood that patients will be cured and fewer cases of drug-resistant TB will occur.
"Our goal is to find a new TB treatment regimen available in a once-daily pill form that cures TB in less than two months," says Carol Hamilton, MD, MHS, a founding member of the TBTC and FHI senior scientist who serves as principal investigator for the FHI-Duke site. "The regimen would result in little to no bad reactions. It would be something you could administer along with HIV medications if need be, and it would be safe and effective for children and pregnant women."
Since November 2009, the FHI-Duke partnership has been recruiting participants for two TB clinical trials, each one testing the effectiveness of an alternate treatment regimen. One of the trials, known as TBTC Study 26 or "Prevent TB," is the largest study of latent TB ever funded by the CDC. Eight-thousand participants are taking part across several sites, including 214 currently enrolled at the FHI-Duke site.
"There are three new TB drugs being tested in humans now, for possible inclusion in a new and improved TB treatment strategy. Another 10 drugs are being evaluated in the laboratory and in animal studies," Hamilton says. "This is the richest pipeline of potential new TB drug options available in the past 40 years. FHI is committed to being part of the global solution to the huge global problem of drug-susceptible and drug-resistant TB."